Pharma Manual PDF

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Pharmaceutical Guidelines: Guidelines for Quality Assurance 30 common ways to avoid making the most frequent GMP errors Adverse reaction of pharmaceutical dosages forms An overview of ISO 14644 clean room classification Analytical method validation Biocontamination control techniques for purified water sysem Chemical Sanitization of RO Systems and Biofilm Removal Clean Room System in Sterile Pharmaceutical Clean Rooms And Controlled Areas (Sterile Area Classification) Cleaning Validation Protocol for Pharmaceuticals Cleaning Validation in Pharmaceuticals Cleaning Validation of Pharmaceutical Equipments Cleaning and Disinfection of a Newly Purified water system before Start Up Clinical Trials Concept of Revalidation in Pharmaceuticals Corrective and Preventive actions (CAPA) Deviation Control in Pharmaceuticals Differece between water (moisture) content and loss on drying (LOD) Difference among calibration, validation & qualification FDA´s New Process Validation Guidance Facility Qualification in Pharmaceuticals GMP Audit Check List- Equipment GMP Audit Check List- Filling and Packaging GMP Audit Check List- Personnel and Premises GMP Audit Check List- Process Validation GMP Audit Check List- Sanitation and Hygiene GMP Audit Check List- Storage of Starting Materials GMP Audit Check List- Weighing and Dispensing GMP Audit Check List- water supply system GMP Observations in Production Good Documentation Practices (GDP) in Pharmaceuticals Guide To Inspections of High Purity Water Systems Guidelines for preparation of Site Master File (SMF) Guidelines for the preparation of VMP (Validation Master Plan) HEPA filters used in pharmaceuticals HVAC system validation tests Handling of Pharmaceutical Market Complaints Handling of out of calibration instruments and equipment High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations Hold time study of cleaned equipments List of Standard Operating Procedures (SOPs) in Quality Assurance Media Fill Validation -SVP Media fill validation test in sterile pharmaceutical Mix Up and Cross Contamination in Pharmaceutical Manuacturing Non-sterile Process Validation in Pharmaceuticals www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Passivation of Purified water system/ WFI system in pharmaceuticals Pharmaceutical Bioavailability and Bioequivalence Pharmaceutical product recall procedure Prevention of Cross - contamination during Processing Prevention of Cross- contamination by HVAC in Pharmaceuticals Prevention of Cross- contamination in Pharmaceuticals Procedure for Change Control in Pharmaceuticals Procedure for garment change and entry and exit through first and primary change room Procedure for in process checking during off-line and on line packing in pharmaceuticals Procedure for line clearance before commencing any manufacturing operation Procedure for preparation of APR (Annual Product Review) Procedure for the qualification of vendors for the raw material and packaging materials Product Recall Procedure in Pharmaceuticals Prospective Validation Protocol for hold time study of prepared control standard endotoxin (CSE) Purified Water System Purified Water System Validation Purpose of Process Validation in Pharmaceuticals Qualification of systems and equipments in pharmaceuticals Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical Rounding Off Values In GMP Documents in Pharmaceuticals Rounding off figures of analytical results SOP of SOP (SOP on SOP) in Pharmaceuticals SOP on Standard Operating Procedure Site Master File (SMF) for pharmaceuticals Summary of ISO 14644 (ISO cleanliness classes) Terminology & Definitions in Pharmaceuticals Types of water used in pharmaceutical processes Validation in pharmaceutical manufacturing Validation of Supporting Processes in Pharmaceuticals WHO Qualification List for Pharmaceutical Equipments WHO SOP list for Pharma Microbiology WHO SOP list for Pharma Production WHO SOP list for Pharma Quality Assurance WHO SOP list for Pharma Quality Control WHO SOP list for Pharma Quality Control Cleaning WHO SOP list for Pharma Quality Control Operations WHO: Water for pharmaceutical use What WHO says about cross-contamination? What is HEPA filter? Its use in Pharma What is change control ? cGMP guidelines for pharmaceutical industries part-1 cGMP guidelines for pharmaceutical industries part-2 cGMP regulations for finished pharmaceuticals and medical devices

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Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Guidelines for Quality Control Analytical Balance Calibration Analytical method validation Appearance of Solution Assay of Ascorbic acid Assay of Calcium Carbonate Assay of Calcium Citrate Atomic Absorption Spectrometry Atomic Emission Spectrometry Bursting Strength Tester Calibration of Brookfield viscometer in pharmaceuticals Calibration of Disintegration Test Apparatus Calibration of FT-IR Spectrophotometer Calibration of Halogen moisture analyzer Calibration of TOC (Total Organic Carbon)Analyser Calibration of Total organic carbon Analyzer Calibration of UV / Visible spectrophotometer Calibration of Volumetric Glassware used in Pharmaceuticals Calibration of automatic potentiometric titrator Calibration of digital polarimeter Calibration of eppendorf centrifuge apparatus Calibration of glassware (class A and class B) Calibration of hardness tester in pharmaceuticals Calibration of melting point apparatus Calibration of refractometer in pharmaceuticals Calibration of vernier caliper Cleaning of Glassware With Nitric Acid and Chromic Acid Climatic zones for stability studies Conductivity of Purified Water (Apparatus and Procedure) in Pharmaceutical Congealing Range or Temperature Contents (Weight or Volume Uniformity) of Packaged Dosage Forms Determination and Acceptance limits of Uniformity of Content of Single-Dose Preparations Determination of Acetyl Value Determination of Acid Value Determination of Assay of Nitrous Oxide Determination of Assay of Oxygen Determination of Assay of Steroids Determination of Assay of Vitamin D Determination of Boiling Range or Temperature and Distillation Range Determination of Esters Determination of Ethanol-Soluble Extractive Determination of Foreign Organic Matter Determination of Freezing Point Determination of Hydroxyl Value Determination of Iodine Value Determination of Loss on Ignition Determination of Methoxyl www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Determination of Nitrogen Determination of Optical Rotation and Specific Optical Rotation Determination of Peroxide Value Determination of Refractive Index Determination of Saponification Value Determination of Solubility in Pharmaceuticals Determination of Sulphur Dioxide Determination of Total Organic Carbon in Purified Water Determination of Total Solids Determination of Unsaponifiable Matter Determination of Viscosity by Using Ostwald-type, Suspended-level and Rotating Viscometer Determination of Weight Per Millilitre and Relative Density Determination of Zinc Content Differece between water (moisture) content and loss on drying (LOD) Difference among calibration, validation & qualification Dimensions of Hard Gelatin Capsule Shells Disintegration Test and Apparatus Dissolution Test (DT) Apparatus Operating Procedure Dissolution Test and Apparatus Dissolution Testing apparatus calibration in pharmaceuticals Flame Photometry (Apparatus and Method) Fluorimetry Friability Test Apparatus Calibration Friability of Uncoated Tablets GC Calibration Good Documentation Practices (GDP) in Pharmaceuticals Good Laboratories Practice (GLP) in Pharmaceuticals Guideline for preparation of mobile phase required for HPLC Guidelines For Receipt And Usage of Reference Standards and Qualification and Usage of Working Standards Guidelines for Pharmaceutical Stability Study HPLC Caibration in Pharmaceuticals HPLC Column Performance Evaluation and Column Care Handling of out of calibration instruments and equipment Handling, Cleaning & Storage of Cuvettes of Spectrophotometer Havey Metals Testing ICH Guidelines for Pharmaceuticals Identification Test of Barbiturates Identification of Environmental Flora Identification test of Phenothiazines Indicator (Litmus Paper) and Test Papers Investigation on sterility failure Ionising Radiation Sterilisation Karl fisher apparatus calibration in pharmaceuticals Limit Test for Aluminium Limit Test for Arsenic in Pharmaceuticals Limit Test for Heavy Metals in Pharmaceuticals Limit Test for Iron and Lead www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Limit Test for Potassium and Sulphates List of Current ICH Quality Guidelines for Stability List of Standard Operating Procedures (SOPs) in Quality Control (QC) Maintenance of Primary Standards in Pharmaceutical Industries Melting Range or Temperature (Apparatus and Deternination) Method for Nitrite Titration Operating Procedure for Weighing Balances Paper Chromatography (Apparatus and Peocedure) Particle Size by Microscopy Pharmaceutical Analytical Method Validation With Definitions Pharmaceutical Bioavailability and Bioequivalence Pharmaceuticals Limit tests Potentiometric Titration Powder Fineness (Types of Powder) Preparation and Standardisation of Volumetric Solutions Preparation and Standardization of 0.004 M Benzethonium Chloride Preparation and Standardization of 0.1 M Ceric Ammonium Nitrate Preparation and Standardization of 0.0005 M Dioctyl Sodium Sulphosuccinate Preparation and Standardization of 0.001 M Sodium Dodecyl Sulphate Preparation and Standardization of 0.0167 M Potassium Dichromate Preparation and Standardization of 0.02 M Cupric Sulphate Preparation and Standardization of 0.02 M Mercuric Nitrate Preparation and Standardization of 0.02 M Potassium Permanganate Preparation and Standardization of 0.05 M Magnesium Sulphate Preparation and Standardization of 0.05 M Barium Chloride Preparation and Standardization of 0.05 M Bromine Preparation and Standardization of 0.05 M Iodine Preparation and Standardization of 0.05 M Potassium Iodate Preparation and Standardization of 0.1 M Ammonium Thiocyanate Preparation and Standardization of 0.1 M Ceric Ammonium Sulphate Preparation and Standardization of 0.1 M Disodium Edetate (EDTA) Preparation and Standardization of 0.1 M Ethanolic Potassium Hydroxide Preparation and Standardization of 0.1 M Ethanolic Sodium Hydroxide Preparation and Standardization of 0.1 M Ferric Ammonium Sulphate Preparation and Standardization of 0.1 M Ferrous Ammonium Sulphate Preparation and Standardization of 0.1 M Hydrochloric acid (HCl) Preparation and Standardization of 0.1 M Lead Nitrate Preparation and Standardization of 0.1 M Lithium Methoxide Preparation and Standardization of 0.1 M Perchloric acid Preparation and Standardization of 0.1 M Potassium Hydroxide Preparation and Standardization of 0.1 M Silver nitrate Preparation and Standardization of 0.1 M Sodium Methoxide Preparation and Standardization of 0.1 M Sodium Nitrite Preparation and Standardization of 0.1 M Sodium Thiosulphate Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide Preparation and Standardization of 0.1 M Titanium Trichloride Preparation and Standardization of 0.1 M Zinc Chloride Preparation and Standardization of 0.1 M Zinc Sulphate www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Preparation and Standardization of 0.25 M Ethanolic Sulphuric Acid Preparation and Standardization of 0.5 M Methanolic Hydrochloric Acid Preparation and Standardization of 0.5 M Potassium Hydroxide in ethanol (60 per cent ) Preparation and Standardization of 0.5 M Sulphuric Acid Preparation and Standardization of 1 M Nitric Acid Preparation and Standardization of 1M Hydrochloric Acid Preparation and Standardization of Volumeteric Solutions Preparation of Buffer Solutions Preparation of Indicator Solutions Preparation of Standard Solutions Primary Standards used in Pharmaceuticals Principle and Calibration of Ultraviolet and Visible Absorption Spectrophotometry Procedure for the qualification of vendors for the raw material and packaging materials Purified Water Specification as per IP/BP/USP Purified Water System Purified Water System Validation Purified Water Testing (Method of analysis) as per IP/BP/USP Purified water testing in Pharmaceuticals Raw Water Testing (Method of Analysis) as per IP/BP/USP Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical Resolution factor, Telling factor, Theoretical Plates and Capacity factor in HPLC Retesting of raw materials Rounding Off Values In GMP Documents in Pharmaceuticals Rounding off figures of analytical results Sampling procedure for purified water Sampling, preservation and storage procedure of water sample Size-Exclusion Chromatography Specification for water for injection (WFI) as per USP Tapped Density Tester Terminology & Definitions in Pharmaceuticals Test for Free Formaldehyde (Formaldehyde Content) Test for Sulphated Ash and Total Ash Testing procedure (Method of analysis) for Acetates,Acetyl Groups and Alkaloids Testing procedure (Method of analysis) for Aluminium Salts, Amines and Ammonium salts Testing procedure (Method of analysis) for Antimony, Arsenic and Barium Salts Testing procedure (Method of analysis) for Benzoates, Bicarbonates and Bismuth Compounds Testing procedure (Method of analysis) for Bromides, Calcium Salts and Carbonates Testing procedure (Method of analysis) for Chlorides, Citrates and Esters Testing procedure (Method of analysis) for Ferric salts, Ferrous Salts and Iodides Testing procedure (Method of analysis) for Lactates, Lead Compounds and Magnesium Salts Testing procedure (Method of analysis) for Mercury Compounds, Nitrates and Phosphates (Orthophosphates) Testing procedure (Method of analysis) for Potassium Salts, Salicylates and Silicates Testing procedure (Method of analysis) for Silver Compounds, Sodium Salts and Sulphates Testing procedure (Method of analysis) for Sulphur in Organic Compounds, Tartrates and Thiosulphates Testing procedure (Method of analysis) for Xanthines and Zinc Salts Thin-Layer Chromatography (TLC Method and Apparatus) www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Types of water used in pharmaceutical processes UV Cabinet Calibration in Pharmaceuticals UV Light Efficiency Test Ultrasonic bath Ultraviolet and Visible Absorption Spectrophotometer (Apparatus and Calibration) Uniformity of Weight of Single-Dose Preparations Update on Schedule L1 Vacuum pump Validation of excel calculation sheets Viscometer calibration WHO SOP list for Pharma Quality Control WHO SOP list for Pharma Quality Control Cleaning WHO SOP list for Pharma Quality Control Operations Water Content Determination by Karl Fischer What is Loss on Drying ? and Determination of Loss on Drying cGMP guidelines for pharmaceutical industries part-1 cGMP guidelines for pharmaceutical industries part-2 pH Values (Apparatus and Method of Determination)

Guidelines for Microbiology An overview of ISO 14644 clean room classification Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Assay of Biotin or Vitamin B7 (Biological method) in Pharmaceuticals Assay of Folic Acid or Vitamin B9 (by microbiological method) Autoclave Validation in Pharmaceuticals BET: Bacterial Endotoxin (LAL)Test. Bacterial Endotoxin Test (BET or LAL Test) Validation Bacterial Endotoxin Test Methods Biocontamination control techniques for purified water sysem Biological Indicator for Dry Heat Sterilization Processes Biological Indicator for Moist Heat (Steam) Sterilization Processes Calibration of Heating block Calibration of Micropipettes Calibration of Microscope Chemical Sanitization of RO Systems and Biofilm Removal Clean Room System in Sterile Pharmaceutical Clean Rooms And Controlled Areas (Sterile Area Classification) Cleaning and Disinfection of a Newly Purified water system before Start Up Culture Media D value, Z value and F0 value calculations Destruction of microbial waste Difference among calibration, validation & qualification Disinfectant Efficacy Test Effectiveness of Antimicrobial Preservatives in Pharmaceutical Drugs Endotoxin Detection by End-Point Chromogenic Method Endotoxin Detection by Gel-Clot Limit Test Method Endotoxin Detection by Gel-Clot Methods www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Endotoxin Detection by Kinetic Thrbidimetric and Kinetic Chromogenic Methods Endotoxin Detection by Quantitative Methods Endotoxin Detection by Semi-Quantitative Gel-Clot Method GMP Audit Check List- Equipment GMP Audit Check List- Filling and Packaging GMP Audit Check List- Personnel and Premises GMP Audit Check List- Process Validation GMP Audit Check List- Sanitation and Hygiene GMP Audit Check List- Storage of Starting Materials GMP Audit Check List- Weighing and Dispensing GMP Audit Check List- water supply system GMP Observations in Production Good Documentation Practices (GDP) in Pharmaceuticals Good Laboratories Practice (GLP) in Pharmaceuticals Growth Promotion Test Guide To Inspections of High Purity Water Systems HEPA filters used in pharmaceuticals HVAC system validation tests High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations How Sterilization is done by Filtration? Identification of Environmental Flora Investigation on sterility failure Ionising Radiation Sterilisation MLT (Microbial Limit Test) Validation MLT: Microbial Limit Test Maintenance of Microbial cultures Media Fill Validation -SVP Media fill validation test in sterile pharmaceutical Microbiological Assay of Cyanocobalamin or Vitamin B12 Mix Up and Cross Contamination in Pharmaceutical Manuacturing Passivation of Purified water system/ WFI system in pharmaceuticals Performance Evaluation of Biological Indicators Performance Qualification Protocol for Sterilization and Depyrogenating Tunnel Performance Qualification of Autoclave cum Bung Processor Performance Qualification of High Pressure High Vaccum (HPHV) Steam Sterilizer in Pharmaceuticals Personnel monitoring of sterile area Preservative Efficacy Test Prevention of Cross - contamination during Processing Prevention of Cross- contamination by HVAC in Pharmaceuticals Prevention of Cross- contamination in Pharmaceuticals Procedure for air sampling (environmental monitoring) in sterile pharmaceutical manufacturing area Procedure for garment change and entry and exit through first and primary change room Protocol for hold time study of prepared control standard endotoxin (CSE) Purified Water System Purified Water System Validation Pyrogens Testing in Pharmaceuticals www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Qualification of systems and equipments in pharmaceuticals Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V Sampling procedure for purified water Sampling, preservation and storage procedure of water sample Steam sterilisation (Heating in an autoclave) Sterility testing procedure Sterlity Validation (Membrane Filtration) in Pharmaceuticals Types of Biological Indicators Types of water used in pharmaceutical processes Update on Schedule L1 Validation in pharmaceutical manufacturing Validation of Dry Heat Sterilizer (DHS) Validation of Supporting Processes in Pharmaceuticals Validation of shelf life for 70% v/v isopropyl alcohol (IPA) WHO SOP list for Pharma Microbiology WHO: Water for pharmaceutical use What WHO says about cross-contamination? What is HEPA filter? Its use in Pharma cGMP guidelines for pharmaceutical industries part-1 cGMP guidelines for pharmaceutical industries part-2 cGMP regulations for finished pharmaceuticals and medical devices

Guidelines for Production 30 common ways to avoid making the most frequent GMP errors Biocontamination control techniques for purified water sysem Chemical Sanitization of RO Systems and Biofilm Removal Clean Room System in Sterile Pharmaceutical Clean Rooms And Controlled Areas (Sterile Area Classification) Cleaning Validation Protocol for Pharmaceuticals Cleaning Validation in Pharmaceuticals Cleaning Validation of Pharmaceutical Equipments Cleaning and Disinfection of a Newly Purified water system before Start Up Concept of Revalidation in Pharmaceuticals Difference among calibration, validation & qualification Dry granulation process Film coating process in pharmaceuticals Film coating process of tablets in pharma manufacturing GMP Audit Check List- Equipment GMP Audit Check List- Filling and Packaging GMP Audit Check List- Personnel and Premises GMP Audit Check List- Process Validation GMP Audit Check List- Sanitation and Hygiene GMP Audit Check List- Storage of Starting Materials GMP Audit Check List- Weighing and Dispensing GMP Audit Check List- water supply system GMP Observations in Production www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Good Documentation Practices (GDP) in Pharmaceuticals Granulation and particle-bonding mechanism of granulation Guideline for pharmaceutical packing operation High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations Hold time study of cleaned equipments List of Standard Operating Procedures (SOPs) in Production Media Fill Validation -SVP Media fill validation test in sterile pharmaceutical Mix Up and Cross Contamination in Pharmaceutical Manuacturing Non-sterile Process Validation in Pharmaceuticals Operating Procedure for Weighing Balances Operation and Cleaning of Machanical Sifter Operation and Cleaning of Octagonal Blender Operation and Cleaning of Roll Compector Operation and Cleaning of Tablet Deduster Machine Operation and Cleaning of Tablet Inspection Machine Operation and Cleaning of Tray Dryer Passivation of Purified water system/ WFI system in pharmaceuticals Pharmaceutical Analytical Method Validation With Definitions Prevention of Cross - contamination during Processing Prevention of Cross- contamination by HVAC in Pharmaceuticals Prevention of Cross- contamination in Pharmaceuticals Procedure for Operation and Cleaning of Metal Detector Procedure for Operation and Cleaning of Rapid Mix Granulator (RMG) Procedure for garment change and entry and exit through first and primary change room Procedure for in process checking during off-line and on line packing in pharmaceuticals Procedure for line clearance before commencing any manufacturing operation Purified Water System Purified Water System Validation Purpose of Process Validation in Pharmaceuticals Sugar coating process and its problems in pharmaceuticals Tablet coating problems and their solutions in pharmaceuticals Terminology & Definitions in Pharmaceuticals Tooling of Oral Solid Dosage Form (Tablet) Types of water used in pharmaceutical processes Validation in pharmaceutical manufacturing Validation of Supporting Processes in Pharmaceuticals WHO Qualification List for Pharmaceutical Equipments WHO SOP list for Pharma Production Wet Granulation Process What WHO says about cross-contamination? cGMP guidelines for pharmaceutical industries part-1 cGMP guidelines for pharmaceutical industries part-2 cGMP regulations for finished pharmaceuticals and medical devices

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Index of all Pharmaceutical Guidelines. Click on Guideline to Open. Standard Operating Procedures (SOPs) for Pharmaceuticals SOP For Operation And Calibratioin of Polarimeter SOP For Analysis And Release of Finished Sample SOP For Backup/Restore And Archival of Analytical Data,In Electronic Form SOP For Calibration Of Colony Counter SOP For Calibration Of Glasswares SOP For Calibration Of Hot Air Oven SOP For Calibration Procedure of BOD / Bacteriological Incubator SOP For Calibration of UV-Vis Spectrophotometer SOP For Cleaning And Operation of Horizontal Autoclave SOP For Cleaning And Operation of Verticle Autoclave SOP For Cleaning Of Quality Control Laboratory SOP For Cleaning Of Refrigerator SOP For Cleaning Of Sampling Equipment SOP For Cleaning and sterilization of glassware used in microbiology lab . SOP For Cleaning of microbiology lab SOP For Control of Record of Analysis SOP For Entry/Exit Procedure For Quality Control Laboratory SOP For Good Laboratory Practice SOP For HPLC Analysis And Documentation SOP For Handling Of Glassware SOP For Identification Of Micorganisms SOP For Laminar Flow Workbench SOP For Maintenance Of Desiccator SOP For Media Preparation And Growth Promotion Test SOP For Monitoring Of Raw And Potable Water Quality SOP For Operating Procedure For Air Sampler SOP For Operation And Calibration Of FT-IR Spectrometer SOP For Operation And Calibration Of Hot Air Oven SOP For Operation And Calibration Of Leak Test Apparatus SOP For Operation And Calibration Of Refractometer SOP For Operation And Calibration Of Tap Density Apparatus SOP For Operation And Calibration Of Vernier Caliper SOP For Operation And Calibration Of Water Bath SOP For Operation And Calibration Of pH Meter (Pico+) SOP For Operation And Calibration of Auto Titrator (Metrohm) SOP For Operation And Calibration of Microscope SOP For Operation And Calibration of Sieve Shaker SOP For Operation Of C/75 % RH) Control Envronment Chamber (40 SOP For Operation Of Milli- Q Water System SOP For Operation Of Muffle Furnace SOP For Operation Of UV Cabinet SOP For Operation and Calibration of Melting Point Apparatus SOP For Operation of Bacteriological Incubator www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP For Operation of C/75 % RH) Control Envronment Chamber (30 SOP For Operation of HPLC System Using Chemistation Software SOP For Operation of UV- Visible Spectrophotometer SOP For Preparation And Standardisation Of Volumetric Solution SOP For Preparation Of Standard, General Reagent And Indicator Solution SOP For Preparation of Culture Of Microorganism SOP For Preventive Maintenance Of Instrument SOP For Procedure For Glasswares Washing SOP For Procedure For Opening of Lyopholized Vial of Microorganism SOP For Qualification of Facility/Equipments/Systems SOP For Recrding of Analytical Data In Raw Data Sheet SOP For Safety Measurs of QC Laboratory SOP For Sampling Of Raw Material SOP For Storage Of Sampling Tool SOP For The Enumeration of Spore Count In Biological Indicators SOP For Validation Of Autoclave With Biological Indicator For Sterilization Efficiency SOP For Washing Of HPLC Column SOP For handling of market complaints SOP for Antimicrobial effectiveness testing SOP for Bacterial Endotoxin Test SOP for Clean Inspection of media fill vials and qualification of inspectors SOP for Cleaning and Operation of Anaerobic Culture Jar SOP for Cleaning and sanitization of Microbiology lab SOP for Cleaning of Glassware SOP for Cleaning of Glassware for Microbiological testing SOP for Collection and Testing of samples during Process Simulation SOP for Deaeration of Dissolution media SOP for Dispensing and Issuance of Raw Material SOP for Disposable of mediafill vials after incubation SOP for Disposal of Contaminated Material SOP for Disposal of media fill vials SOP for Entry and Exit procedure for microbiology testing area and Sterility testing area SOP for Entry and exit in Microbiology testing area SOP for Handling and Storage of Raw & Packing Material SOP for Handling of Market Complaints in Pharmaceuticals SOP for Identification of microbial cultures using biomeriux identification system SOP for Investigation on sterility failure, which is required to find out the route cause, and to take the appropriate actions for future analysis SOP for Karl Fischer apparatus SOP for L.O.D. oven SOP for Microbial Limit Test of Raw material and Finished product SOP for Microbial analysis of swab samples from equipment surfaces SOP for Microbial assay SOP for Microbial staining procedures SOP for Microbiology start up procedure after shut down www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for Monitoring of Compressed Air/Gases for Microbiological, Non-Viable Particulate, Oil and Moisture Content SOP for Monitoring of microbiology laboratory SOP for Operating and cleaning of distilled water unit SOP for Operation & Maintenance Of Fogger SOP for Operation and Calibration of Analytical Balance SOP for Operation and Calibration of Conductivity meter SOP for Operation and Calibration of Conductivity meter SOP for Operation and Calibration of Micropipette SOP for Operation and Calibration of Top Pan Balance SOP for Operation and Calibration of pH meter SOP for Operation and Cleaning of Air Sampler SAS 180 L SOP for Operation and Cleaning of Colony Counter SOP for Operation and Cleaning of Deep Freezer SOP for Operation and Cleaning of Garment Cubicle SOP for Operation and Cleaning of Incubator SOP for Operation and Cleaning of Microscope SOP for Operation and Cleaning of Microscope SOP for Operation and Cleaning of Pass box SOP for Operation and Cleaning of Steam Sterilizer SOP for Operation and Cleaning of Triobloc SOP for Operation and Cleaning of Vertical Portable Autoclave SOP for Operation and Maintenance of Fogger SOP for Operation and Maintenance of Sterilization Reel Sealer SOP for Operation and Maintenance of Water Purification System SOP for Operation and Performance qualification of Biomerieux Kit (mini API, Densimat and Electronic pipette) SOP for Operation and calibration of leak tester SOP for Operation of Milliflex Water filtration Unit SOP for Operation of Rady Count Down Timer SOP for Operation, Cleaning and Monitoring of Bio-Safety Cabinet SOP for Operation, Cleaning and Monitoring of Laminar Air Flow SOP for Operation, Maintenance & Calibration of Heating Block SOP for Personnel Qualification of personnel entering into Aseptic area and Sterility Testing area SOP for Planning for analysis and reporting of result SOP for Post Sterility Growth Promotion Test SOP for Preparation of Culture Inoculum SOP for Preparation of Trends SOP for Preparation, Review and Approval of Standard Operating Procedures SOP for Procedure For Bioburden, BET, And LPC Of Primary Packaging Materials SOP for Procedure for Bacterial Endotoxin (LAL) test SOP for Procedure for Changeovers carried out in Manufacturing and Packing area SOP for Procedure for Die Blocking SOP for Procedure for Handling Of Out Of Specification Results In Microbiological Testing www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for Procedure for Handling of Out Of Limit Results in Environmental Monitoring and Water Analysis. SOP for Procedure for Manufacturing of Tablets & Capsules SOP for Procedure for Operation of Air Sampler SOP for Procedure for Operation of Deduster Cum Metal Detector SOP for Procedure for Operation of Tablet Branding Machine SOP for Procedure for Operation, Calibration, and System Suitability of Total Organic Carbon (TOC) Analyser SOP for Procedure for Receipt of Raw and Packing Material SOP for Procedure for Stereo Ordering, Issue, Receipt & Destruction of Rubber Stereos SOP for Procedure for Storage and Preparation of Microbiological Culture Media SOP for Procedure for Testing of Biological Indicators SOP for Procedure for analysis of Water SOP for Procedure for preparation of dresses for sterilization. SOP for Procurement, Maintenance and Sub-culturing of Standard Microbial Cultures SOP for Sampling and Testing of Pure Steam SOP for Sterility Testing By Membrane Filtration Method SOP for Sterility Testing Using Manifold For Dilution Study and Stability SOP for Sterility testing of compressed air, Nitrogen & Carbon dioxide SOP for Sterility using Streitest Equinox SOP for Sterilization by Autoclaving for Microbiological testing SOP for Swab sampling for validation of test surface to evaluate cleaning efficacy. SOP for Temperature, Humidity and Differential Pressure Monitoring SOP for Testing of Particulate Matter in Injections and Operation and Maintenance of Liquid Particle Counter SOP for Validation Process For Checking Effectiveness Of Disinfections / Cleaning Procedure SOP for a procedure for preparation of the volumetric solutions SOP for action to be taken during unusual observation for instrument during calibration SOP for allocating identification number to instrument/ equipment SOP for autoclave SOP for bacteriological incubator SOP for behaviour in quality control department SOP for calibration Total Organic Carbon (TOC) Analyser SOP for calibration coulter counter SOP for calibration of HPLC column oven SOP for calibration of halogen moisture analyzer SOP for calibration of pH meter temperature sensor SOP for calibration of Atomic absorption spectrophotometer (AAS) SOP for calibration of Autotitrator SOP for calibration of Brook field viscometer SOP for calibration of Gas chromatograph SOP for calibration of HPLC (low pressure quaternary gradient liquid chromatograph) SOP for calibration of Head Space Gas Chromatograph SOP for calibration of Mercury filled glass thermometer SOP for calibration of Micropipettes www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for calibration of Polarimeter SOP for calibration of automatic box compression strength tester (digital model) SOP for calibration of autotitrator SOP for calibration of balance SOP for calibration of balance SOP for calibration of bursting strength tester SOP for calibration of conductivity TDS meter SOP for calibration of conductivity meter SOP for calibration of disintegration test apparatus SOP for calibration of glassware SOP for calibration of hardness tester SOP for calibration of high performance thin layer chromatography SOP for calibration of infrared moisture balance SOP for calibration of infrared spectrophotometer SOP for calibration of karl fischer apparatus SOP for calibration of melting point apparatus SOP for calibration of pipettes, burettes and volumetric flasks used in Quality control SOP for calibration of plunger operated pipette SOP for calibration of refractometer SOP for calibration of refractometer SOP for calibration of slit – to – agar air sampler SOP for calibration of the refractometer SOP for calibration of walk-in- incubators 20-25°c and 30-35°c SOP for calibration pH meters SOP for calibration procedure of u.v.cabinet SOP for calibration programme SOP for careful handling of poisonous chemicals SOP for centrifuge machine SOP for check suitability of dissolution test apparatus SOP for check the Fertility properties of the procured Media SOP for cleaning SOP for cleaning and disinfection SOP for cleaning and c) c- 35 operation of BOD incubator (30 SOP for cleaning and operation of RLAF unit in Sampling Room SOP for cleaning and operation of bio- safety cabinet SOP for cleaning and operation of incubator SOP for cleaning and sanitization of microbiology section SOP for cleaning for DHS SOP for cleaning in microbiology section SOP for cleaning of Autodiluter SOP for cleaning of Dispensing & Sampling Room SOP for cleaning of Halogen Moisture Analyser SOP for cleaning of Metrohm Karl fisher SOP for cleaning of Quality Control Dept. throughout working SOP for cleaning of Vertical Autoclave www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for cleaning of autoclave SOP for cleaning of automatic distillation apparatus SOP for cleaning of box compression strength tester SOP for cleaning of colony counter SOP for cleaning of disintegration test apparatus SOP for cleaning of disintegration test apparatus SOP for cleaning of dispensing utensils SOP for cleaning of dissolution tester SOP for cleaning of fourier transform infrared spectrophotometer SOP for cleaning of friability test apparatus SOP for cleaning of high performance liquid chromatography (HPLC) SOP for cleaning of melting point apparatus SOP for cleaning of microscope SOP for cleaning of oven for incubator at 55°c SOP for cleaning of oven for depyrogenation SOP for cleaning of slit to agar air sampler SOP for cleaning of steritest SOP for cleaning of tablet hardness tester SOP for cleaning of tap density apparatus SOP for cleaning procedure for karl fischer apparatus SOP for cleaning procedure for Alu-Alu Packing Machine SOP for cleaning procedure for Automatic Cartoning Machine SOP for cleaning procedure for Automatic Coating System SOP for cleaning procedure for Bins & HDPE Containers SOP for cleaning procedure for Blister Packing Machine SOP for cleaning procedure for Checkweigher SOP for cleaning procedure for Colloidal Mill SOP for cleaning procedure for Conveyor Belt SOP for cleaning procedure for Deblistering machine SOP for cleaning procedure for Deburring and Dedusting Machine SOP for cleaning procedure for Dehumidifier SOP for cleaning procedure for Drum mixer SOP for cleaning procedure for EPD Collator machine with strip packing machine line SOP for cleaning procedure for Exhaust Ducts in Coating area SOP for cleaning procedure for FBD Bag SOP for cleaning procedure for Fluidised bed Dryer SOP for cleaning procedure for Hose Pipe Of Dust Extraction System SOP for cleaning procedure for Metal Detector SOP for cleaning procedure for Mini roll compactor SOP for cleaning procedure for Octagonal Blender SOP for cleaning procedure for Paste Kettle SOP for cleaning procedure for Pressure Vessel, Peristaltic Pump & spraying gun SOP for cleaning procedure for Rapid Mixer Granulator (R.M.G.) SOP for cleaning procedure for S.S. Vessel and Utensils SOP for cleaning procedure for Semi-Automatic Cartoning Machine www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for cleaning procedure for Stirrer SOP for cleaning procedure for Strip Packing Machine SOP for cleaning procedure for Tablet Compression Machine SOP for cleaning procedure for Vacuum Cleaner SOP for cleaning procedure for Vibro Sifter SOP for cleaning procedure for brooke field viscometer SOP for cleaning procedure for cad mill SOP for cleaning procedure for capsule filling cubicle SOP for cleaning procedure for capsule filling line SOP for cleaning procedure for centrifuge SOP for cleaning procedure for coulter counter SOP for cleaning procedure for dissolution test apparatus SOP for cleaning procedure for gas chromatograph (head space) SOP for cleaning procedure for heating block SOP for cleaning procedure for high performance thin layer chromatograph SOP for cleaning procedure for microbiological laboratory other than clean area. SOP for cleaning procedure for microscope SOP for cleaning procedure for multi mill SOP for cleaning procedure for pallet SOP for cleaning procedure for polarimeter SOP for cleaning procedure for refracto meter SOP for cleaning procedure for semi auto induction cap sealing machine SOP for cleaning procedure for tablet counter SOP for cleaning procedure for u.v. /visible spectrophotometer SOP for cleaning procedure for u.v. /visible spectrophotometer SOP for cleaning procedure for ultrasonic bath SOP for cleaning procedure for vacumme oven SOP for cleaning procedure for water bath SOP for cleaning procedure for water purification system SOP for cleaning procedure for zone reader SOP for cleaning procedure of atomic absorption spectrophotometer SOP for cleaning procedure of balances SOP for cleaning procedure of bursting strength tester SOP for cleaning procedure of deep freezer SOP for cleaning procedure of polariscope SOP for cleaning procedure of puncture resistance tester SOP for cleaning procedure of quardrant meter SOP for cleaning procedure of sterile dress cabinate SOP for cleaning procedure of water bath SOP for cleaning, operation and calibration of Antibiotic Zone Reader SOP for collection and storage of retained samples of packaging material SOP for collection and storage of retained samples of raw material SOP for collection of swab sample SOP for control of master data generation by computer system SOP for destroy the inprocess, finished product and raw materials samples timely after testing www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for destruction of control samples (Raw material and Finished product) SOP for dispatch the Finished Goods out side the factory premises from BSR SOP for dispensing and issuing of Packing Material as per the requirement from Production Department SOP for disposal of empty media conatiner SOP for disposal of expired chemicals, reagents, solvents and micro-biological medium. SOP for disposal of microbial culture media and cleaning of glassware used for culture media SOP for disposal of rejected Packing Material SOP for disposal procedure for media containing growth SOP for entry and exit in Microbiological Testing Area (MLT/Sterility Room) SOP for entry and exit in Microbiology Section SOP for environmental monitoring of aseptic area by air sampling for viable count using air sampler SOP for environmental monitoring of dispensing and sampling area in raw materials SOP for environmental monitoring of manufacturing area of solid dosage form by settling plate count SOP for environmental monitoring of solid dosage form area by non viable air particle count SOP for environmental monitoring of walk-in-incubators SOP for evaluation of compressed air in manufacturing of Pharmaceutical products SOP for evaluation of environmental monitoring results (trend analysis) SOP for for allocating document protocol number for instrument qualification SOP for for measurement of particle size of raw materials using microscopic method SOP for general test procedure SOP for gowning procedure SOP for gowning procedure for the visitors SOP for growth promotion test and calibration of inoculum SOP for guideline for storage condition of raw material SOP for guideline for the system suitability test for HPLC analysis SOP for guidelines for Microbiology laboratory SOP for hand wash procedure SOP for handling & usage of hazardous chemicals SOP for handling and control for the prohibited items SOP for handling and testing of inprocess sample SOP for handling and testing of various samples SOP for handling of biological indicators SOP for handling of glassware SOP for handling of reference and working standard SOP for handling of spillage of solid/liquid media containing growth SOP for handling of the spillages in the laboratory SOP for heat distribution study in chamber of depyrogemation oven using different probe with data logger SOP for heat distribution study in chamber of dry heat sterilizer using different probe with data logger SOP for heat distribution study in oven using multi probe data logger SOP for heating block validation SOP for hplc column receipt checking and regeneration SOP for identification of contaminant in sterile area SOP for identification of organisms www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for instrument for macroscopical examination SOP for inventory and issuances of media in quality control lab SOP for investigation for out of action level results of monitoring of micro biological environment SOP for investigation of sterility test failure SOP for laboratory cleaning SOP for laboratory safety SOP for lal test by gel clot method SOP for laminar air flow workstation SOP for leak seal test apparatus SOP for leak test of strip, blister and alu – alu blister sealing SOP for logic for giving number to the method for analysis of finished product and raw material SOP for logic for giving number to the method for analysis of packaging material SOP for maintenance & cleaning procedure for sampling equipment SOP for maintenance and transfer of stock cultures SOP for maintenance of desiccator SOP for manual glassware cleaning procedure SOP for media disposal SOP for media preparation SOP for media preparation SOP for media stock maintenance and suitability testing of media SOP for method for programme file checks of software of instruments SOP for metone laser particle counter SOP for microbial limit test for raw materials and finished products SOP for microbial monitoring of drainage in solid dosage manufacturing area SOP for microbiological integrity testing of vials SOP for microbiological monitoring of clean equipment in to solid dosage area. – swab method SOP for microscope SOP for monitoring UV Light Efficiency LAF & Pass Box SOP for muffel furnace SOP for numbering system of media SOP for operating procedure of Dehumidifier SOP for operating procedure of colony counter SOP for operating procedure of culture cabinet SOP for operating procedure of data logger SOP for operating procedure of double door autoclave SOP for operating procedure of fogster –ULV fogger machine SOP for operating procedure of laminar air flow SOP for operating procedure of water bath. SOP for operation & calibration of digital Colony Counter SOP for operation and calbration of dry bath SOP for operation and calibration of bulk density apparatus SOP for operation and calibration of bursting strength tester SOP for operation and calibration of friability test apparatus SOP for operation and calibration of pH meter (GMPH) SOP for operation and calibration of pH meter (pH tutor) www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for operation and calibration of tablet disintegration apparatus SOP for operation and calibration of vacuum oven SOP for operation and cleaning of LAF unit in Sampling Room SOP for operation and cleaning of Refrigerator SOP for operation and monitoring of performance of dynamic pass box SOP for operation and monitoring of performance of garment cabinet SOP for operation of Laminar Air Flow SOP for operation of centrifuge machine SOP for operation of magnetic stirrer with hot plate SOP for operation of micrometer SOP for operation of particle counter SOP for operation of sampling booth SOP for operation of sonicator SOP for operational check of disintegration test apparatus SOP for operational check of friability test apparatus SOP for operational qualification of dissolution tester SOP for oven for depyrogenetion SOP for oven for incubation at 55 deg c SOP for palm swabbing SOP for performance check of karl fisher SOP for performance check of UV - visible spectrophotometer (Jasco) SOP for performance check of UV/visible spectrophotometer SOP for performance check of autodiluter SOP for performance check of fourier transform infrared SOP for performance checks of karl fischer apparatus SOP for performance of low temperature water bath SOP for personnel monitoring in aseptic area SOP for physical monitoring of microbiology section SOP for plate exposure SOP for preparation and handling of primary standard SOP for preparation and standardisation of volumetric solutions SOP for preparation of Culture dilutions SOP for preparation of Rejection Note SOP for preparation of bench reagents SOP for preparation of microbial culture media SOP for preparation of sterile petridishes, agar slants and agar butts SOP for preparation, approval, issue, control, uncontrol and revision of quality manual SOP for preservation of Control samples of Active ingredients SOP for procedure environmental monitoring of parenteral processing area : by settling plate count method. SOP for procedure for Handling of Lysate. SOP for procedure for Material and Product Labeling in Production department SOP for procedure for Operation and cleaning of Automatic Batch Printing Machine SOP for procedure for Operation of Alu Alu blister pack machine SOP for procedure for Operation of Automatic Capsule Filling Line www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for procedure for Operation of Automatic Coating System (NEOCOTA 48”) SOP for procedure for Operation of Batch Printing Machine (Semi Automatic) SOP for procedure for Operation of Colloid Mill SOP for procedure for Operation of Compression Machine 20 station (Single Rotary Type) SOP for procedure for Operation of Compression Machine 27 station (Double Rotary Type) SOP for procedure for Operation of Deblistering Machine SOP for procedure for Operation of Deburring & Dedusting Machine SOP for procedure for Operation of Drum mixer SOP for procedure for Operation of Fluidised Bed Dryer SOP for procedure for Operation of Multimill SOP for procedure for Operation of Octagonal Blender (1000 liter) SOP for procedure for Operation of Paste Kettle SOP for procedure for Operation of Rapid Mixer Granulator (RMG) SOP for procedure for Operation of Stirrer SOP for procedure for Operation of Strip Packing Machine SOP for procedure for Operation of Tablet Inspection machine SOP for procedure for Operation of Vacuum Test Apparatus SOP for procedure for Operation of Vibro Sifter SOP for procedure for Operation of Volume Delivering Systems (Peristaltic Pump) SOP for procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies & Punches SOP for procedure for Packing of Tablets/Capsules in strip pack or blister pack as primary packing & packing of strips or blisters in cartons, shipper as secondary packing SOP for procedure for Pre Filter cleaning of RLAF SOP for procedure for Receipt, Issuance, Storage and Handling of solvent SOP for procedure for Tablet Inspection SOP for procedure for Tablet granulation, compression and coating SOP for procedure for action to be taken during spillage/breakage of materials SOP for procedure for analyst validation SOP for procedure for calibration of thermometer SOP for procedure for challenge test of solid Flow Monitor in Fluid Bed Dryer SOP for procedure for cleaning and storage of flexible pipes SOP for procedure for cleaning of barrel pump & pipe SOP for procedure for cleaning of clean area SOP for procedure for cleaning of equipment and accessories in Production Area SOP for procedure for conduct a temperature mapping exercise in store to identify the location of the worst point at which the thermometer and hygrometer for daily monitoring needs to be placed SOP for procedure for destruction of online rejects of printed and overprinted packaging materials SOP for procedure for disposal of wastage and transfer to ETP SOP for procedure for entering in inoculation room SOP for procedure for entering in sterility testing room SOP for procedure for environmental monitoring of aseptic area :non viable particle count of air SOP for procedure for environmental monitoring of aspetic area: finger prints and gown sampling SOP for procedure for environmental monitoring of clean area and LAF modules. SOP for procedure for environmental monitoring of parenteral processing area : surface testing by means of rodac plate and swab www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for procedure for evaluation of analyst’s performance SOP for procedure for fumigation in microbiology lab SOP for procedure for handling of Rejected Packing Materials SOP for procedure for handling of Rejected Raw Material SOP for procedure for handling of Tablet Counter SOP for procedure for handling of sieves and screen SOP for procedure for house-keeping of stores SOP for procedure for issuance of additional packaging materials SOP for procedure for linearity check of high performance liquid chromatograph SOP for procedure for maintaining machine use log SOP for procedure for making production related entries in SAP system SOP for procedure for operating and cleaning of Vacuum Cleaner SOP for procedure for operation and calibration of precision oven SOP for procedure for operation and cleaning of Carton Sealing Machine SOP for procedure for operation of Cad mill SOP for procedure for operation of EPD Collator coupled with strip packing machine SOP for procedure for operation of conveyor belt in packing SOP for procedure for operation of mini roll compactor SOP for procedure for operation of semi auto induction cap sealing machine SOP for procedure for operation of ‘Bliss’, the online inspection system SOP for procedure for overprinting of batch details on cartons and catch covers SOP for procedure for performance of automatic distillation apparatus SOP for procedure for preparation and handling of working standard SOP for procedure for proper disposal of expired finished goods SOP for procedure for receipt, numbering, usage and destruction of FBD filter bag SOP for procedure for recleaning SOP for procedure for reconciliation of Raw Materials and Packing Materials SOP for procedure for recording of Temperature & Humidity in Stores Department SOP for procedure for recording of Temperature and Humidity in Raw Material Store and Temperature recording in Packing Material Store for maintaining proper storage conditions SOP for procedure for recording of Temperature in Production Department SOP for procedure for recording of differential pressure in Production area. SOP for procedure for return of Raw & Packing materials from production department SOP for procedure for safely and effectively clean and disinfect the drains SOP for procedure for sampling and testing schedule of water for injection and clean steam SOP for procedure for sampling of the packaging material SOP for procedure for sieve analysis SOP for procedure for stacking of packed shippers on pallet SOP for procedure for stenciling of shippers used for packing SOP for procedure for sterility testing SOP for procedure for storage & transference of dispensed raw material in day store SOP for procedure for storage of temperature sensitive raw materials SOP for procedure for the Blister Pack Machine SOP for procedure for the intimation of break down of utilities services & equipments in manufacturing & packing department during working www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for procedure for the operation of Automatic Cartoning Machine SOP for procedure for the operation of Semi-Automatic Cartoning Machine (VP-120) SOP for procedure for the operation of checkweigher SOP for procedure for the preventive maintenance of all quality control instruments SOP for procedure for transfer of the finished goods to bonded store room SOP for procedure for validation of microbiologist SOP for procedure for vehicle Inspection SOP for procedure for washing the HPLC column after use SOP for procedure of fumigation in production area by using 5 % Gramicid and Fogger SOP for procedure of sampling of raw material SOP for procedure to specify the responsibilities of production department SOP for procurement and handling of reference standard SOP for proper disposal of contaminated material to ensure all media containing microbial growth are disposed properly SOP for qualification of Biological Indicator SOP for quantification of culture SOP for raw material release SOP for receipt and maintenance of working standards of API SOP for receiving the samples in microbiology lab SOP for release of finished product SOP for retesting of Raw Materials SOP for retesting schedule of packaging material SOP for retesting schedule of raw material SOP for retesting schedule of raw material (for API) SOP for rounding off the analytical test results SOP for routine cleaning verifictaion by TOC-SSM method SOP for safety in quality SOP for sampling and release of Inprocess samples SOP for sampling and release of raw materials SOP for sampling and testing schedule of purified water SOP for sampling of Finished product SOP for sampling of packing material SOP for sampling of water SOP for selection criteria and its procedure before dissolution profile study SOP for slit to agar air sampler SOP for statistical study for trend analysis of purified water and water for injection SOP for steam penitration study by bowie-dick test SOP for sterile dress cabinet SOP for sterilization of accessories by dry heat sterilization SOP for storage and use of reagents & chemicals SOP for subculturing & maintenance of microbial cultures SOP for testing & release/rejection of Finished product SOP for testing for bioburden of fractional solutions SOP for testing of compressed air and nitrogen gas for viable count SOP for testing of miscellaneous sample www.pharmaguideline.com

Index of all Pharmaceutical Guidelines. Click on Guideline to Open. SOP for the procedure for Operation of Rapid Mixer Granulator SOP for training procedure for qc persons SOP for trend analysis SOP for ultrasonic cleaner SOP for use of logcard for equipment status SOP for validation of DHS with biological indicator SOP for validation of autoclave SOP for validation of autoclave with biological-indicator SOP for validation of clean area & equipment lying in clean area SOP for validation of oven for depyrogeneation. SOP for verification of system suitability test SOP for verification of system suitability test measured by chrom card software for GC SOP for vortex mixer SOP for water sampling procedure SOP for writing method of analysis for P.M SOP of SOP (SOP on SOP) in Pharmaceuticals SOP on Standard Operating Procedure SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V

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