Specifities of the ISO 22716 standard Good Cosmetic Manufacturing Practices version 2007

13/10/2023

See the quiz "ISO 22716 requirements version 2007".

ISO 22716 version 2007 is the standard for guidelines on Good Manufacturing Practices for cosmetic products.

ISO 22716 is a standard (in substance) and guidelines (in content).

ISO 22716 requirements version 2007

The course T 23v07 ISO 22716 readiness version 2007 and its free demo without registration

The course T 43v07 ISO 22716 internal audit version 2007 and its free demo without registration

The training package T 73v07 ISO 22716 readiness and internal audit

1. ISO 22716 Structure

The ISO 22716 cosmetic Good Manufacturing Practices guidelines include 17 articles:

Scope
Terms and definitions
Personnel
Premises
Equipment
Raw materials and packaging materials
Production
Finished products
Quality control laboratory
Treatment of product that is out of specification
Wastes
Subcontracting
Deviations
Complaints and recalls
Change control
Internal audit
Documentation

2. Terms

Terms and definitions in article 2 are 36:

- acceptance criteria
- audit
- batch
- batch number
- bulk product
- calibration
- change control
- cleaning
- complaint
- contamination
- consumables
- contract acceptor
- control
- deviation
- finished product
- in-process control
- internal audit
- major equipment
- maintenance
- manufacturing operation
- out-of-specification
- packaging operation
- packaging material
- plant
- premises
- production
- quality assurance
- raw material
- recall
- reprocessing
- return
- sample
- sampling
- sanitization
- shipment
- waste

3 DOCUMENTATION

The requirements (recommendations) of the documentation are not specified, but in practice the necessary procedures can be:

- Training (Article 3)
- Responsibilities and authorities (Article 3)
- Control of the working environment (Article 4)
- Maintenance (Article 5)
- Purchasing (Article 6)
- Receipt (Article 6)
- Identification and traceability (Article 6)
- Production (Article 7)
- Release (Article 8)
- Laboratory (Article 9)
- Inspection (Article 9)
- Subcontracting (Article 12)
- Deviations (Article 13)
- Handling of complaints and recalls (Article 14)
- Change control (Article 15)
- Internal audit (Article 16)
- Corrective action (Article 16)
- Control of documents (Article 17)

Instructions (templates, records) which can be used:

- process sheet
- job description sheet
- change notice
- training certificate
- prior learning assessment
- measuring equipment verification range
- procedure model
- instruction model
- certificate of conformity
- list of subcontractors
- supplier survey
- subcontractor quality claim
- quarterly subcontractor quality indicator
- reception anomaly
- shipping request
- carrier claim
- job sheet
- maintenance record
- maintenance worksheet
- batch tracking sheet
- inspection results
- non-conformance sheet
- customer deviation
- internal auditor's list
- audit plan
- audit program
- audit report

4. Cosmetic regulation articles CE 1223/2009

- CHAPTER I SCOPE, DEFINITIONS
  - Article 1 Scope and objective
  - Article 2 Definitions
- CHAPTER II SAFETY, RESPONSIBILITY, FREE MOVEMENT
  - Article 3 Safety
  - Article 4 Responsible person
  - Article 5 Obligations of responsible persons
  - Article 6 Obligations of distributors
  - Article 7 Identification within the supply chain
  - Article 8 Good manufacturing practices
  - Article 9 Free movement
- CHAPTER III SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION
  - Article 10 Safety assessment
  - Article 11 Product information file
  - Article 12 Sampling and analysis
  - Article 13 Notification
- CHAPTER IV RESTRICTIONS FOR CERTAIN SUBSTANCES
  - Article 14 Restrictions for substances listed in the Annexes
  - Article 15 Substances classified as CMR substances
  - Article 16 Nanomaterials
  - Article 17 Traces of prohibited substances
- CHAPTER V ANIMAL TESTING
  - Article 18 Animal testing
- CHAPTER VI CONSUMER INFORMATION
  - Article 19 Labelling
  - Article 20 Product claims
  - Article 21 Access to information for the public
- CHAPTER VII MARKET SURVEILLANCE
  - Article 22 In-market control
  - Article 23 Communication of serious undesirable effects
  - Article 24 Information on substances
- CHAPTER VIII NON-COMPLIANCE, SAFEGUARD CLAUSE
  - Article 25 Non-compliance by the responsible person
  - Article 26 Non-compliance by distributors
  - Article 27 Safeguard clause
  - Article 28 Good administrative practices
- CHAPTER IX ADMINISTRATIVE COOPERATION
  - Article 29 Cooperation between competent authorities
  - Article 30 Cooperation regarding verification of the product information files
- CHAPTER X IMPLEMENTING MEASURES, FINAL PROVISIONS
  - Article 31 Amendment of the Annexes
  - Article 32 Committee procedure
  - Article 33 Glossary of common ingredient names
  - Article 34 Competent authorities, poison control centres or assimilated entities
  - Article 35 Annual report on animal testing
  - Article 36 Formal objection to harmonised standards
  - Article 37 Penalties
  - Article 38 Repeal
  - Article 39 Transitional provisions
  - Article 40 Entry into force and date of application
- ANNEX I COSMETIC PRODUCT SAFETY REPORT
- ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS (1379)
- ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN OUTSIDE THE RESTRICTIONS LAID DOWN (296)
- ANNEX IV LIST OF COLOURING AGENTS THAT MAY BE PRESENT IN COSMETIC PRODUCTS (153)
- ANNEX V LIST OF PRESERVATIVES PERMITTED IN COSMETIC PRODUCTS (59)
- ANNEX VI LIST OF ULTRAVIOLET FILTERS ALLOWED IN COSMETIC PRODUCTS (30)
- ANNEX VII SYMBOLS USED ON THE PACKAGING/CONTAINER
- ANNEX VIII LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING
- ANNEX IX PART A Repealed Directive with its successive amendments (referred to in Article 33)
- ANNEX IX PART B List of time-limits for transposition into national law and application (referred to in Article 33)
- ANNEX X MAPPING TABLE