ISO 22716
Good Manufacturing Practices (GMP) for Cosmetics
Overview
ISO 22716 was developed by the International Organization for Standardization (ISO) to meet the recently revised European cosmetics regulations and international requirements. It has already been adopted as the Good Manufacturing Practices (GMP) standard for cosmetics in several countries. ISO 22716 provides a comprehensive approach to the production of cosmetics, covering everything from the import of raw materials to the release of finished products, including manufacturing, packaging, testing, storage, transportation, and post-market activities. This standard is highly integrated with existing quality management systems like ISO 9001, facilitating system integration and transition. The main benefit of implementing ISO 22716 is the ease of obtaining international certifications and regulatory approvals.
Scope
ISO 22716 provides guidelines for the manufacturing, management, storage, and transportation of cosmetics. These guidelines focus on quality-related aspects of products, while safety for personnel and environmental protection must comply with local regulations. The guidelines do not cover product design and development.
Terms and Definitions
Chapter 2 of ISO 22716 introduces several terms that differ from general GMP, including:
- (1) Bulk Product: Products that have completed all processes prior to final packaging.
- (2) Deviation: Intentional or unintentional temporary situations where requirements for roles and responsibilities within GMP activities are not met.
- (3) Major Equipment: Essential equipment for processes listed in production and testing documentation.
- (4) Out of Specification (OOS): Test, measurement, or investigation results that do not meet established criteria.
Human Resources
Chapter 3 outlines requirements for organizational structure and personnel. Organizations must establish a structure suitable for their size, products, and related activities, with clear definitions of roles within sub-organizations. Sufficient personnel with adequate training and experience are required for specific roles. Detailed requirements for responsibilities, communication, training, personal hygiene, health, and access for visitors or untrained personnel are specified.
Facilities
Facilities must prevent contamination, protect products, and support cleaning, disinfection, and maintenance. Layouts should be simple, and GMP activities require appropriate zoning. Specific requirements cover restrooms, washing areas, walls, ceilings, windows, floors, lighting, ventilation, plumbing, drainage, cleanliness, hygiene, and pest control.
Equipment
All equipment and automation included in GMP activities must be easy to clean, disinfect, and maintain. Regular calibration of measuring equipment is required to ensure validity. Requirements are specified for cleaning, maintenance, disposal of defective equipment, and handling of consumables and equipment.
Raw Materials and Packaging Materials
Chapter 6 specifies requirements for receiving, dispensing, and storing raw materials, including re-evaluation of expired materials and water quality standards when water is used in production.
Production
Before production, conformity criteria for finished products must be established, and procedures for each production process must be developed. Requirements include checks before starting processes, ensuring traceability of in-process products, and specific guidelines for storage of materials and raw materials during each production stage.
Finished Product
Requirements for inspecting finished products, shipping conditions, storage conditions, and identification methods are specified. Procedures for storage, transportation, and returns must ensure product quality.
Quality Control Laboratory
The operation of the quality control laboratory is one of the unique features of ISO 22716 compared to general quality management systems. Its key responsibilities include verifying the conformity of products and materials before release. The laboratory must establish test methods, acceptance criteria, and procedures for handling test results. It must also manage reagents, solutions, standards, and cultures, and meet requirements for sampling techniques and storage/disposal of test samples.
Disposition of Non-Conforming Products
Methods for handling defective materials, products, and out-of-specification products, as well as the personnel responsible, are specified.
Waste
Hygienic disposal, identification, and storage of waste are required.
Outsourcing
When activities within the scope of the standard are outsourced, specific considerations, measures, and requirements must be addressed. A written contract specifying the scope of activities and required quality levels is mandatory. Roles and responsibilities between the contractor and subcontractor must be clearly defined.
Deviation Management
Deviations must be justified and supported by data, and measures must be taken to prevent recurrence.
Customer Complaints and Recalls
Procedures for receiving and handling complaints, planning, and reporting status are required. Detailed requirements for product recalls are also included.
Change Management
Requirements for managing changes that may affect product quality are specified.
Internal Audit
Internal audits must be used to monitor compliance with the standard and to implement corrective actions if necessary. Detailed requirements for planning, implementing, and processing internal audits are included.
Documentation
All companies are required to establish, design, implement, and maintain a documentation system appropriate to their structure, size, and products. This system can be in electronic or printed form. Documentation must define activities specified in the guidelines, serve as a record of GMP implementation, and prevent risks such as misinterpretation, loss of information, confusion, or errors. Requirements for drafting, approval, distribution, and revision of documents are detailed.
Good Manufacturing Practices (GMP) for Cosmetics
OverviewISO 22716 was developed by the International Organization for Standardization (ISO) to meet the recently revised European cosmetics regulations and international requirements. It has already been adopted as the Good Manufacturing Practices (GMP) standard for cosmetics in several countries. ISO 22716 provides a comprehensive approach to the production of cosmetics, covering everything from the import of raw materials to the release of finished products, including manufacturing, packaging, testing, storage, transportation, and post-market activities. This standard is highly integrated with existing quality management systems like ISO 9001, facilitating system integration and transition. The main benefit of implementing ISO 22716 is the ease of obtaining international certifications and regulatory approvals.
Scope
ISO 22716 provides guidelines for the manufacturing, management, storage, and transportation of cosmetics. These guidelines focus on quality-related aspects of products, while safety for personnel and environmental protection must comply with local regulations. The guidelines do not cover product design and development.
Terms and Definitions
Chapter 2 of ISO 22716 introduces several terms that differ from general GMP, including:
- (1) Bulk Product: Products that have completed all processes prior to final packaging.
- (2) Deviation: Intentional or unintentional temporary situations where requirements for roles and responsibilities within GMP activities are not met.
- (3) Major Equipment: Essential equipment for processes listed in production and testing documentation.
- (4) Out of Specification (OOS): Test, measurement, or investigation results that do not meet established criteria.
Chapter 3 outlines requirements for organizational structure and personnel. Organizations must establish a structure suitable for their size, products, and related activities, with clear definitions of roles within sub-organizations. Sufficient personnel with adequate training and experience are required for specific roles. Detailed requirements for responsibilities, communication, training, personal hygiene, health, and access for visitors or untrained personnel are specified.
Facilities
Facilities must prevent contamination, protect products, and support cleaning, disinfection, and maintenance. Layouts should be simple, and GMP activities require appropriate zoning. Specific requirements cover restrooms, washing areas, walls, ceilings, windows, floors, lighting, ventilation, plumbing, drainage, cleanliness, hygiene, and pest control.
Equipment
All equipment and automation included in GMP activities must be easy to clean, disinfect, and maintain. Regular calibration of measuring equipment is required to ensure validity. Requirements are specified for cleaning, maintenance, disposal of defective equipment, and handling of consumables and equipment.
Raw Materials and Packaging Materials
Chapter 6 specifies requirements for receiving, dispensing, and storing raw materials, including re-evaluation of expired materials and water quality standards when water is used in production.
Production
Before production, conformity criteria for finished products must be established, and procedures for each production process must be developed. Requirements include checks before starting processes, ensuring traceability of in-process products, and specific guidelines for storage of materials and raw materials during each production stage.
Finished Product
Requirements for inspecting finished products, shipping conditions, storage conditions, and identification methods are specified. Procedures for storage, transportation, and returns must ensure product quality.
Quality Control Laboratory
The operation of the quality control laboratory is one of the unique features of ISO 22716 compared to general quality management systems. Its key responsibilities include verifying the conformity of products and materials before release. The laboratory must establish test methods, acceptance criteria, and procedures for handling test results. It must also manage reagents, solutions, standards, and cultures, and meet requirements for sampling techniques and storage/disposal of test samples.
Disposition of Non-Conforming Products
Methods for handling defective materials, products, and out-of-specification products, as well as the personnel responsible, are specified.
Waste
Hygienic disposal, identification, and storage of waste are required.
Outsourcing
When activities within the scope of the standard are outsourced, specific considerations, measures, and requirements must be addressed. A written contract specifying the scope of activities and required quality levels is mandatory. Roles and responsibilities between the contractor and subcontractor must be clearly defined.
Deviation Management
Deviations must be justified and supported by data, and measures must be taken to prevent recurrence.
Customer Complaints and Recalls
Procedures for receiving and handling complaints, planning, and reporting status are required. Detailed requirements for product recalls are also included.
Change Management
Requirements for managing changes that may affect product quality are specified.
Internal Audit
Internal audits must be used to monitor compliance with the standard and to implement corrective actions if necessary. Detailed requirements for planning, implementing, and processing internal audits are included.
Documentation
All companies are required to establish, design, implement, and maintain a documentation system appropriate to their structure, size, and products. This system can be in electronic or printed form. Documentation must define activities specified in the guidelines, serve as a record of GMP implementation, and prevent risks such as misinterpretation, loss of information, confusion, or errors. Requirements for drafting, approval, distribution, and revision of documents are detailed.
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