Operating Qualification

 

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT ------------------------------------------------------------------------------------------------------------------

VIBRO SIFTER    30” DIA. (GMP MODEL) OPERATING QUALIFICATION  M/s. Milan Laboratories India Pvt. Ltd,

CLIENT PARTY’S REF. (P.O) NO. MONTH & YEAR OF MFG.

2009-2010

LOCATION

Panvel

OUR REF. NO. JOB NO.

521006

MODEL NO.

30VS  

 Allied  MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT  

Unit No. 17, Param Industrial Estate, Naik Pada, Waliv, Vasai (East), District Thane- 401 208, Maharashtra, India. Fax: 0250 –: 245167 2451675 5  Tel : 6451697, 6451697, 645430 6454301, 1, 2451674  

 

 

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

PROTOCOL APPROVAL COVER PAGE

 

The signatures below indicate approval of this protocol. Once signatures are obtained, execution of the protocol may begin. Department

Authorized Person

Signature

Date

Initiated by

Reviewed by  Approved by

CONTENTS Sr. No. 1.0 2.0 3.0 4. 4.0 0 5.0 5.1 5.2 5.3 5.4 6. 6.0 0 7.0

TITLE

Introduction Rationale Responsibilities Equ quip ipme ment nt Crit Critic ical al to Study tudy Qualification Description   Prerequisites   Start Up   Emergency Stop   Power Failure Cr Crit iter eria ia For For Acc Accep epta tabi bili lity ty Conclusion   OQ Data Sheets Operational Qualification Approval Page

1.0

2.0 2.0

INTRODUCTION

1.1

The object objective ive of this this Protocol Protocol is to provide provide guide guideline lines s for the instal installatio lation n of the Vibro Sifter.

1.2

Insta Installa llatio tion n deta details ils for the Vibro Vibro sifte sifterr are availab available le in installa installatio tion n qu quali alific ficati ation on Protocol (II/PP/RPT/QUA/18). The operation of the equipment is described in the SOP titled operation of Vibro sifter SOP No. II/PP/SOP/OPR/3

1. 1.3 3

The The ob obje ject ctiv ive e of as this thisper st stud udy y designed is to asse assess ss th the e ab abil ilit ity y ofstudy the siftin sift g eq equi uipm pmen enttthe to operate correctly the parameters. The willing also assess electrical operations.

RA RATI TION ONAL ALE E FO FOR R QUAL QUALIF IFIC ICAT ATIO ION N PROG PROGRA RAMM MME E Page 2

 

 

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

The sifter functions by imparting vibratory energy to the granules in the bowl by means vibrating motor. The amount of energy imparted is proportional to the motor speeds. These functions of the equipment will be challenged within the anticipated operational limits. Also, all electrical and sealing operations of the equipment equipment shall be qualified. qualified. The equipment equipment will be validated for the following functions in manual and auto mode: 2.1 Critical operating parameters: parameters:   2.1.1 Leakage 2.1.2 Material movement   2.1.3 Vibration. 2.2 Power Failure 3.0

RESPONSIBILITIES

3.1

3. 3.2 2

Th The e respo responsi nsibil bility ity of of the Vali Valida datio tion n Team Team is overal overalll adhere adherenc nce e to this this protoc protocol. ol. Specific duties include: 3.1.1 3.1. 1

Monitorin Monitoring g Protocol Protocol complete completeness ness,, accuracy, accuracy, technica technicall excellence excellence and applicability.

3.1.2 3.1. 2 3.1. 3.1.3 3 3.1.4 3.1. 4 3.1.5 3.1. 5 3.1. 3.1.6 6

Scheduli Schetenance duling ng and and Opera Operation tional aln Qualif Qu ication ion activ activity ity nt Maintena Main nce and and calib calibratio ration of alificat valid validatio ation n equipme equ ipment Conducti Conducting ng the the Opera Operation tional al Qu Qualif alificat ication ion activity activity Data review review of of valida validation tion Prot Protocol ocol preparati preparation on Appr Approv oval al of Pr Prot otoc ocol ol

Th The e resp respon onsi sibi bili lity ty of of the the Q.A. Q.A. D Dep epar artm tmen entt incl includ udes es:: 3.2.1 3.2.1 3.2. 3.2.2 2 3.2.3 3.2 .3

3.3

Issue Issue validat validation ion d data ata s shee heett to the the valid validatio ation n team team Revi Review ew of of vali valida dati tion on dat data a Ap Appro proval val of val valida idatio tion n Prot Protoc ocol ol

Th The e respo responsi nsibil biliti ities es of of Formu Formulat lation ion De Deve velop lopmen mentt are are as as follo follows: ws:

3.3. 3.3.1 1 To make make cr crit itic ical al equi equipm pmen entt avai availa labl ble e for for va vali lida dati tion on.. equipment is listed in Section 4 of this protocol) 3.3.2 3.3 .2 Rev Review iew of of data data and and appro approva vall of Proto Protoco coll 3. 3.4 4

(The (The

Ex Exce cept ptio iona nall Cond Condit itio ions ns and and Dev Devia iati tion ons s  Any minor changes or deviations deviations that are necessary necessary to comply with this protocol will be documen documented ted in the final Protocol. Protocol. Any significa significant nt changes changes or deviations deviations altering the scope or intent of this protocol require prior approval by the original signatories and documentation in the final Protocol.

4.0

EQUIPME IPMENT NT CRITIC ITICAL AL TO STUD TUDY 4. 4.1 1 Ca Cali libr brat ated ed Stop Stopwa watc tch h (ta (tag g no no IIIE IE 29) 29) 4. 4.2 2 Ca Cali libr brat ated ed Tech Techno nome mete terr (tag (tag no. no. II IIE E 30) 30) 4.3 Vibro ibro Sifte ifterr (T (Tag no IIE - 55)

5.0

QUALIFICATION PR PROGRAMME Page 3

 

 

5.1

Prerequisites 5.1.1 5.1. 1 5.1.2 5.1. 2 5.1.3 5.1. 3

5.1.4 5.1. 4

5.2

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

Confirm Confirm that the equipme equipment/s nt/syste ystem m is installed, installed, the Installa Installation tion Qualific Qualificatio ation n completed and installation package approved, and is ready for operation. Confirm Confirm that that the operati operating ng SOP exists exists,, in draft or ap approv proved ed form, form, to support support operational testing. Verify Verify that all instrume instruments nts associat associated ed with this equipm equipment/ ent/syst system, em, incl includin uding g those to be used for testing, have been calibrated and that the re-calibration dates will not expire before execution of this protocol has been completed. Verify Verify that all all material materials s and test test equipmen equipmentt are availab available le for the execu execution tion of of this Protocol.

Start-Up 5.2.1 5.2. 1 Ensure Ensure that that the the main main ele electric ctrical al suppl supplies ies are are ‘ON’ ‘ON’ 5.2.2 5.2. 2 Switch Switch ‘ON’ ‘ON’ the the power power at at the the main main switch switch cabinet cabinet.. 5.2.3 5.2. 3 Ensure Ensure that that equi equipmen pmentt is clean cleaned ed befo before re operat operation. ion. 5.2.4 5.2 .4 Che Checks cks tha thatt sievin sieving g scree screen n fits fits pro prope perly rly.. 5.2.5 5.2 .5 En Ensur sure e that that all all gaske gaskets ts are are clo closed sed.. 5.2.6 5.2. 6 Ensure Ensure that that mater material ial moves moves in circul circulatio ation n motion motion 5.2.7 5.2 .7 Sta Start rt the sif siftin ting g opera operatio tion n 5.2.8 5.2 .8 Run the the mac machin hines es for 30 mins. mins.  ACCEPTANCE  ACCEPTAN CE CRITERIA: CRITERIA: All operations operations should should be smooth. smooth.

5.3

Noise Generation 5.3.1 5.3. 1 Run the the Vibro Vibro Sifter Sifter for some some time time and obser observe ve for gene generati ration on of noise. noise.  ACCEPTANCE  ACCEPTAN CE CRITERIA: CRITERIA: No noise noise generation. generation.

5.4

Direction of of Ro Rotation 5.4.1 5.4 .1 che check ck the direct directio ion n of of moto motor  r 

5.5

Seals 5.5.1 5.5. 1 5.5.2 5.5 .2

Visually Visually check check for leaks leaks from top lid lid and and top top deck. deck. Visua Visually lly che check ck for for leaks leaks from from ‘C’ Clam Clamp. p.

 ACCEPTANCE  ACCEPTA NCE CRITERIA: CRITERIA: No leakage leakage

6.0

CRITE ITERIA FOR ACCEPT CEPTA ABI BIL LITY ITY The Operations Qualification of Vibro Sifter shall be considered acceptable if individual operating operatin g parameters fall within anticipated anticipated acceptable acceptable limits. If the results do not meet anticipated acceptance limits, the review team shall meet and agree corrective actions.

7.0

CONCLUSION The collected collected data shall be analyze analyzed, d, evaluate evaluated d and reviewed reviewed against against the acceptab acceptable le limits lim its for operat operation ion.. Th The e co concl nclus usion ions s sh shall all be drawn based based on revie review w of data and suggestions shall be made to optimize the operational efficiency of equipment.

DRAWING - I Page 4

 

 

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

OQ DATA SHEETS IDENTIFICATION OF PERSONNEL PERFORMING OPERATIONAL QUALIFICATION   DEPARTMENT

SIGNATURE

DATE

OQ DATA SHEET

STEP

5.1.1

5.1.2

5.1.3

5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9

5.1.10

REQUIRED

RECORDED

ACCEPTANCE CRITERIA

Confirm equipment / system installed, I.Q.

IQ documents reviewed and

complete and ready for operation.

approved.

Confirm SOP exists

SOP exists

Confirm instruments calibrated and recalibration date not expired. Verify all materials and test equipment available

All instruments calibrated.

Test equipments available

Verify electrical supplies

All utilities available in right

are “ON” Verify equipment cleaning

capacity. Should be cleaned

Sieving screen Should not generate noise from damp and feed hopper 

Fits properly  No noise

Material should move in circulation direction

Material movement in circulation direction

Continuous material movement through discharge chute

Material moves out of discharge chute continuously

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

OPERATIONAL QUALIFICATION APPROVAL PAGE OBSERVATION:

CONCLUSION:

SUGGESTION:

 _________________  _____________ ____   PREPARED BY:

(Formulation Technologist)

_____________ _________________ ____ REVIEWED BY:

_____________ _________________  ____  APPROVED BY:

(Manager Formulation Development) (Quality Assurance Dept)

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