SFS-EN ISO 22716

Scope

ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution of finished products.

The standards writing body responsible for this document in Finland is Kemesta.

Table of contents

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Personnel

3.1 Principle
3.2 Organization
3.3 Key responsibilities
3.4 Training
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 Pipework, drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest control

5 Equipment

5.1 Principle
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 Principle
6.2 Purchasing
6.3 Receipt
6.4 Identification and status
6.5 Release
6.6 Storage
6.7 Re-evaluation
6.8 Quality of water used in production

7 Production

7.1 Principle
7.2 Manufacturing operations
7.3 Packaging operations

8 Finished products

8.1 Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns

9 Quality control laboratory

9.1 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 materials
10.2 Reprocessed finished products and bulk products

11 Wastes

11.1 Principle
11.2 Types of waste
11.3 Flow
11.4 Containers
11.5 Disposal

12 Subcontracting

12.1 Principle
12.2 Types of subcontracting
12.3 Contract giver
12.4 Contract acceptor
12.5 Contract

13 Deviations
14 Complaints and recalls

14.1 Principle
14.2 Product complaints
14.3 Product recalls

15 Change control
16 Internal audit

16.1 Principle
16.2 Approach
16.3 Follow-up

17 Documentation

17.1 Principle
17.2 Type of document
17.3 Writing, approval and distribution
17.4 Revision
17.5 Archiving

Show all

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Personnel

3.1 Principle
3.2 Organization
3.3 Key responsibilities
3.4 Training
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 Pipework, drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest control

5 Equipment

5.1 Principle
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 Principle
6.2 Purchasing
6.3 Receipt
6.4 Identification and status
6.5 Release
6.6 Storage
6.7 Re-evaluation
6.8 Quality of water used in production

7 Production

7.1 Principle
7.2 Manufacturing operations
7.3 Packaging operations

8 Finished products

8.1 Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns

9 Quality control laboratory

9.1 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 materials
10.2 Reprocessed finished products and bulk products

11 Wastes

11.1 Principle
11.2 Types of waste
11.3 Flow
11.4 Containers
11.5 Disposal

12 Subcontracting

12.1 Principle
12.2 Types of subcontracting
12.3 Contract giver
12.4 Contract acceptor
12.5 Contract

13 Deviations
14 Complaints and recalls

14.1 Principle
14.2 Product complaints
14.3 Product recalls

15 Change control
16 Internal audit

16.1 Principle
16.2 Approach
16.3 Follow-up

17 Documentation

17.1 Principle
17.2 Type of document
17.3 Writing, approval and distribution
17.4 Revision
17.5 Archiving

Product group(s)

71.100.70 Cosmetics. Toiletries »

Relationships

Normative references

No references for this publication.

Technical committee

CEN/TC 392 Cosmetics »

Directive

1223/2009 Commission communication in the framework of the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

http://ec.europa.eu »

Date of implementation

12.05.2008

Published

12.12.2008

Edition

1

Pages

50

Language(s)

Finnish/English