ISO 22716:2007 provides internationally recognized Good Manufacturing Practices (GMP) for the cosmetic industry, focusing on the production, control, storage and shipment of cosmetic products. The standard offers practical guidelines to ensure that products are consistently manufactured and controlled to meet quality and hygiene standards appropriate for their intended use.
This standard bridges the gap between regulatory requirements, such as those from the EU Cosmetic Regulation (EC) No 1223/2009, US FDA, and ASEAN Guidelines, and operational practices in manufacturing environments. ISO 22716 is industry-specific, tailored exclusively for cosmetics manufacturers, brand owners and packaging suppliers.
Need help implementing GMP practices for your cosmetic manufacturing process? Contact us at support@demo.pacificcert.com!
ISO 22716 is applicable to:
It applies to the entire product lifecycle, from raw material sourcing and production to packaging, storage, and distribution.
Whether you’re producing skincare, haircare, personal hygiene products, or decorative cosmetics, It ensures that your operations meet international safety and quality expectations.
Want to assess how ISO 22716 applies to your cosmetic facility? Contact us at support@demo.pacificcert.com!
ISO 22716 is widely used as a certification for cosmetic GMP compliance. Certification is voluntary, but it is often required by clients and retailers, especially for export into regulated markets such as the EU and Asia-Pacific.
Steps in the Certification Process:
We at Pacific Certifications guide cosmetic manufacturers through every step of this process. Contact support@demo.pacificcert.com!
Implementation involves integrating GMP principles into your day-to-day cosmetic production and handling processes. Start by appointing a quality management representative and creating a GMP team that includes representatives from production, quality control, warehousing, and HR.
Develop and document standard operating procedures (SOPs) for:
Training, risk analysis, and regular audits are essential to ensure that practices align with both ISO 22716 and national cosmetic regulations.
Need help with auditing your GMP system? Email us at support@demo.pacificcert.com!
To demonstrate ISO 22716 compliance, the following documents are required:
ISO 22716 is suitable for:
Need a pre-certification eligibility review? Contact us at support@demo.pacificcert.com!
Week | Activities |
Week 1 | Initial assessment, scoping, and GMP planning |
Week 2 | SOP development, hygiene controls, and documentation setup |
Week 3 | Staff training, implementation, and operational control review |
Week 4 | Internal audit and corrective actions |
Week 5 | Third-party audit and nonconformity resolution |
Week 6 | Final certification and GMP compliance endorsement |
Want to align your cosmetic operations with ISO 22716? Contact support@demo.pacificcert.com.
The cost of ISO 22716 certification depends on:
We offer customized pricing based on a site review and scope definition. Email support@demo.pacificcert.com for a quote.
Clause No. | Clause Title | Description |
1 | Scope | Defines the scope limited to cosmetic GMP guidelines. |
2 | Normative References | References to ISO standards essential for the application of ISO 22716. |
3 | Terms and Definitions | Provides terminology and definitions used throughout the document. |
4 | Personnel | Requirements for hygiene, qualifications, and responsibilities of staff. |
5 | Premises | Specifies the requirements for buildings and their suitability for operations. |
6 | Equipment | Guidance on the design, maintenance, and cleanliness of manufacturing equipment. |
7 | Raw Materials and Packaging Materials | Requirements for reception, storage, and handling of materials. |
8 | Production | Describes GMP for the manufacturing process to ensure quality and safety. |
9 | Finished Products | Guidelines for storage, shipment, and quality verification of final products. |
10 | Quality Control Laboratory | Requirements for testing, documentation, and control of quality parameters. |
11 | Treatment of Product that is Out of Specification | Procedures for handling non-conforming products. |
12 | Wastes | Management of waste to avoid contamination and ensure regulatory compliance. |
13 | Subcontracting | GMP responsibilities when outsourcing manufacturing or services. |
14 | Deviations | Managing and documenting deviations from established procedures. |
15 | Complaints and Recalls | Procedures for product complaints and product recall management. |
16 | Change Control | Requirements for managing changes that may affect product quality. |
17 | Internal Audit | Guidelines for conducting self-inspections and internal audits. |
18 | Documentation | Covers recordkeeping, SOPs, and traceability of GMP processes. |
Need help aligning your GMP practices with each clause? Contact support@demo.pacificcert.com!
To comply with ISO 22716, organizations must:
Below are the key benefits of implementing ISO 22716:
ISO 22716 is recognized globally as the GMP benchmark for cosmetics. With rising concerns over microbiological contamination and clean beauty standards, both regulators and consumers demand GMP-certified operations.
According to Statista, the global cosmetics market is expected to exceed USD 450 billion by 2027, and ISO 22716 certification is fast becoming a prerequisite for entering this competitive market, especially for private labels and e-commerce sellers.
Retailers such as Sephora, Boots, and Ulta increasingly require ISO 22716-compliant documentation from suppliers, while EU and ASEAN regulations demand strict GMP adherence for market entry.
Want to stay ahead in the global cosmetics market? Contact us to get certified for ISO 22716 at support@demo.pacificcert.com!
We offer end-to-end support for ISO 22716 implementation and certification:
Whether you’re launching a new line or scaling operations, we help ensure compliance and certification success.
Ready to begin your ISO 22716 journey? Contact us at support@demo.pacificcert.com!
Yes, cosmetic companies can obtain third-party certification for compliance with ISO 22716.
Yes, GMP compliance (based on ISO 22716) is mandatory under Regulation (EC) No 1223/2009.
Yes, ISO 22716 is scalable and suitable for businesses of all sizes.
Absolutely—CMOs and private labelers are often required to be GMP compliant.
Yes, it complements ISO 9001 and other quality or safety management systems.
Contact Pacific Certifications to begin your certification journey today!
Suggested Certifications –
Read more: Pacific Blogs
Get a rough Estimate for your Required Certification by entering your basic details.
This will close in 0 seconds
Get in touch!
This will close in 0 seconds
