4 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 6 of ISO 22716 is where supplier management stops being a procurement nicety and becomes a formal GMP requirement. Everything that goes into a finished cosmetic product starts here, and the standard treats this section with the weight that implies.
This post is part of a series working through ISO 22716 section by section. The series summary with links to every section is available at the end.
Raw materials and packaging materials that are purchased should meet defined acceptance criteria relevant to finished product quality. The section then works through the full lifecycle: purchasing, receipt, identification and status, release, storage, re-evaluation, and — separately — the quality of water used in production.
Purchasing. This requires supplier evaluation and selection, defined technical clauses covering acceptance criteria and what happens if there is a defect, and an ongoing relationship involving questionnaires, assistance, and audits. This is the clause that effectively mandates a formal supplier approval process rather than an informal buying relationship.
Receipt. The purchase order, delivery note, and delivered materials all need to match. The integrity of shipping containers needs a visual check, with additional transport checks where necessary.
Identification and status. Containers need labelling to identify the material and batch information, and materials need a clear status — accepted, rejected, or quarantined. The standard specifically allows non-physical identification systems as long as they provide the same level of assurance, which is the clause that makes a digital quarantine status genuinely compliant rather than just convenient.
Release. Only released materials should be used, and release decisions need to come from authorised personnel responsible for quality. The standard also addresses certificate-of-analysis-only acceptance — this is permitted, but only where there is established technical knowledge of the supplier, a supplier audit history, and agreed test methods. It is not a free pass to skip incoming checks entirely.
Storage. Storage conditions need to suit each specific material. Containers need closing and storing off the floor. Stock rotation should generally use the oldest released stock first, and periodic inventory checks need to happen with any significant discrepancy investigated.
Re-evaluation. Materials need re-evaluating after a defined storage period to confirm continued suitability, and the system needs to actively prevent use of materials that are due for re-evaluation but have not received it.
Water quality. Where water is used in production, the treatment system needs to supply a defined quality, verified by testing or process monitoring, with equipment designed to avoid stagnation and contamination risk.
The most common gap is supplier approval that exists as a one-time event rather than an ongoing process. A supplier approved two years ago, with no subsequent monitoring of performance or certificate validity, technically has a record — but that record does not reflect current reality, which is exactly what an auditor is checking for.
The second common gap is re-evaluation. Materials with a defined re-evaluation period often get used past that point simply because nobody is actively tracking the date, particularly for slower-moving stock.
This section is the foundation for everything downstream. A weakness in supplier approval surfaces later as a nonconformance in production. Material identification and status feed directly into production control and batch traceability — if you cannot prove a material was released before use, you cannot prove the batch made from it meets specification either.
This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.
Back to all
