Documents to be elaborated in order to meet ISO 22716.pdf

Documents to be elaborated in order to meet ISO 22716:2007 standard requirements Below you´ll find all the documentation that it is needed to meet ISO 22716:2007, Cosmetics: Good Manufacturing Practices, requirements. Section

Requirement

Required documentation Description

Personnel

3

4

Responsibilities of personnel Training

3.5.1 3.5.2 3.6

Personnel Hygiene and Health

Premises Equipment Raw Materials and Packaging Materials

7

Job Descriptions Personnel and Training Initial Orientation Program Gowning, Hand Washing and Conduct Response Plan for Incidents Involving Biohazards Initial Orientation Program

Record SOP Program SOP SOP Program

Premises Cleaning and Sanitation

SOP

Premises Maintenance Program

Program

4.11

Visitors and Untrained Personnel Premises Cleaning and Sanitation Maintenance

4.13

Pest Control

Pest Control

SOP

5.3 5.4 5.6

Equipment Installation Qualification Control of Measuring and Test Instruments Equipment Cleaning and Sanitation

SOP SOP SOP

5.6

Installation Calibration Equipment Cleaning and Sanitation Maintenance

6.2

Purchasing

SOP Form Form Form Form Form SOP SOP SOP SOP

6.3

Receipt

6.4

Identification and Status

Equipment Maintenance Equipment Technical Data Sheet Equipment Maintenance Checklist Equipment Maintenance Request Equipment Maintenance Work Order Equipment Maintenance Record Purchasing and Assessment of Suppliers Supplier Audits Supplier Corrective Action Request (SCAR) Performance Evaluation of Suppliers of Significant Materials and Services Incoming Inspection Raw materials specifications Identification & Traceability of Raw Materials, Manufactured, and Packaged Products Production and Process Control of Chemical Process Production and Process Control of Machining Process Product Specifications Product Bill of Materials (BOM) Production Work Order Work Instructions for the use of specific equipment (boiler, reactors, filters, drillers, CNC´s, and so on) In-Process Inspection (for chemical and machining process) Production Line Clearance Procedure Production and Process Control of Packaging Process Packaging Product Specifications Packaging Product Bill of Materials Packaging Work Order

4.10

5

6

3.3.2 3.4

Type

Manufacturing operations: Availability of relevant documents

Production

7.2.1 7.2.3 7.2.4 7.2.5 7.2.6 7.2.7

7.2.2 7.3.1 7.3.3 7.3.4 7.3.5

Start-up Checks Packaging Operations

SOP Specs SOP SOP SOP Specs BOM Form WI WI SOP SOP Specs BOM Form

Section

Requirement

Required documentation

8

Finished Product

7

Production

Description

Quality Control Laboratory

9

7.3.1 7.3.2 7.3.6 8.1 8.2 8.3

9.2

Shipment Returns Test Methods

9.3

Acceptance criteria

9.4

Results

9.5

Out-of-Specification Results Reagents, solutions, reference standards, culture media

8.4 8.5

9.6

9.7 9.8

10

15

16

Deviations Complaints and Recalls

14

Sampling Retain Sample Rejected finished products, bulk products, raw materials and packaging materials Reprocessed finished products and bulk products Wastes

Work Instruction for the use of specific equipment (as sealers) Packaging Line Clearance Procedure Packaging In-Process Inspection Final product specification Final Inspection Product Release Shipping Procedure Customer Returns Analysis Procedures (for those not included in the EU Pharmacopoeia) Raw material, in process or final product specifications, establishing the acceptance criteria. Raw material, in process or final testing results forms (indicating the acceptance criteria) OOS Procedure Receipt and Storage of Chemicals Preparation and Standardization of Solutions Cleaning and washing of laboratory glassware Laboratory Basic Safety Rules Sampling Procedure Retains Control of Non-Conforming Product Non-Conforming Event Procedure Root Cause Analysis (RCA) Procedure Rework Procedure

WI

Handling, Storage, Treatment and Disposal of Wastes

SOP

SOP WI Spec WI Form SOP SOP PA Specs Forms SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP

13.1 13.2

Deviations

To be determined Deviation Procedure

SOP

14.2

Product Complaints

Customer Complaints Management

SOP

14.3

Product Recalls

Recall Procedure

SOP

Change Control

Creating and Changing Specifications

SOP

Risk Assessment Procedure

SOP

Corrective and Preventive Action System Procedure

SOP

Internal Audits Procedure

SOP

Subcontracting

Change Control

12 13

10.2

Wastes

OOS product Treatment

10.1

Internal Audits

11

Packaging Operations (continued) Start-up checks In process Control Finished Products

Type

Internal Audits

Section

Requirement

Required documentation

17

Documentation

Description

Documentation

Document Control and Data Control Procedure Signature Authority for Controlled Documents Document Retention Storage and Disposition Good Documentation Practices

Type

SOP SOP SOP SOP

This is the required documentation to be generated in order to meet ISO 22716:2007 requirements. Section 12 is left open because it is not clear if the company will made use of subcontractors in order to perform some specific activities (like dispensing and repackaging). PD:

It is important to take in mind that according to ISO 22716:2007 3.2.11 requirement, the company should ensure that there are adequate staffing levels in the different scope of activity, according to the diversity of production”. That is, the company must ensure that in every key area the personnel who made decisions and perform key activities have the required competences. Thus, it is important to proceed to perform an organizational assessment to verify this point. Sections 4.2 to 4.9 are related to premises design, materials of construction, ventilation, lighting, floors, walls, windows, pipework, drains and ducts. The way to meet these requirements is to perform a diagnostic of the current state of the premises, in order to identify the type of action to be taken, and proceed to establish a Premises Adjustment Plan.