ISO 22716 Consultancy, ISO 22716 Certification, ISO 22716 GMP

ISO 22716 Cosmetic GMP

ISO 22716 Requirements cover

1. Organization

2. Risk Assessment of the proceses

3. Infrastructure and Equipments

4. Training and Competency

5. Good Manufacturing Practices

6. Hygiene, Cleaning and Sanitization

7. Maintenance and Calibration

8. Recall

The requirements of the standard are

1 Scope

2 Terms and Definition

3. Personnel

3.2 Key Responsibilities

3.3.1 Management Responsibilities

3.4 Training

3.4.1 Training and Skills

3.5 Personnel Hygiene and Health

3.6 Visitors and untrained personnel

4 Premises

4.1 Principle

4.2 Types of Area

4.3 Space

4.4 Flow

4.5 Floors, Walls, Ceilings, Windows

4.6 Washing and Toilet facilities

4.7 Lighting

4.8 Ventilation

4.9 Pipe work drains and ducts

4.10 Cleaning and sanitization

4.11 Maintenance

4.12 Consumables

4.13 Pest Control

5 Equipment

5.2 Equipment Design

5.3 Installation

5.4 Calibration

5.5 Cleaning and Sanitization

5.6 Maintenance

5.7 Consumables

5.8 Authorizations

5.9 Back up systems

6 Raw Materials and packaging materials

6.1 The guiding principle

6.2 Purchasing

6.3 Critical and Non-critical raw material

7 Production

7.1 Guiding Principle

7.2 Manufacturing Operations

7.2.1 Availability of relevant document

7.2.2 Startup Checks

7.2.3 Assignment of a batch number

7.2.4 Identification and in process Operations

7.2.5 In process Controls

7.2.6 Bulk Product Storage

7.2.7 Restocking and Raw Materials

7.3 Packaging Operations

7.3.1 Availability of relevant documents

7.3.2 Startup checks

7.3.3 Assignment of Batch number

7.3.4 Packing Line Identification

7.3.5 Checks of on line Control Equipment

7.3.6 In-process

7.3.7 Re-stocking of packaging materials

7.3.8 Identifications

8 Finished products

8.1 Guiding Principle

8.2 Release

8.3 Storage

8.4 Shipment

8.5 Returns

9 Quality Control calibrations

9.1 Guiding Principle

9.2 Test Methods

9.3 Acceptance Criteria

9.4 Results

9.5 Out of specification results

9.6 Reagents, solutions, reference standards, culture, media

9.7 Sampling

9.8 Retain Sample

10 Treatment of product that is out of specification

10.1 Rejected finished products, bulk products, raw materials and packaging

11 Waste Management

11.1 Guiding Principle

11.2 Types of waste

11.3 Food

11.4 Containers

11.5 Disposal

12 Sub contracting

12.2 Types of Subcontract

Manufacturing

Packaging

Analysis

Equipment

Pest Control

12.3 Contract given

12.4 Contract Acceptor

12.5 Written contract agreement

13 Handling of Deviations

14 Complaints and Recalls

14.2 Product complaints

14.3 Product recalls

15 Change Control

16 Internal Audit

17 Documentation

17.2 Types of document

Procedures—Instructions, specifications, protocols, reports

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