Buyer questions · Purchase decisions
If we audit for a major European retailer, what specific SOPs and deviation management documents can you provide to meet the audit requirements?
Claiming to 'establish a system according to ISO 22716' is distinct from 'holding a certificate'; European retailers audit based on their own standards. The focus is on whether written, practical, and recorded processes align. Auditors will check deviation and CAPA closure records, equipment cleaning validation, and sample retention SOPs. BioSphere holds GMPC, ISO 22716, HALAL, FDA, EU CPNP, and SGS certificates. If the audit day finds lines idle, actual production schedules and recent complete batch records for similar products must be provided.
1Deviation & CAPA closure
Provide post-incident investigation and CAPA closure documents. Concealing historical deviations equates to data falsification; if discovered, the system is deemed untrustworthy, a critical fatal defect.
2Equipment & Cleaning Validation
Provide equipment cleaning SOPs and cleaning validation or effect confirmation records. Having a procedure without validation is a high-frequency non-conformance, as 'defined' does not mean 'proven effective'.
3Batch Records & Retention
Key process parameters in batch records must have measured values; ticking boxes is invalid. Retention periods must exceed 'shelf-life + 6 months' and quantities suffice for two full re-tests.
Follow-up questions
- Q:Can you provide ISO 22716 certificates?
- A:BioSphere's public info shows it holds ISO 22716 certificates. If clients require specific third-party certifications, verify possession first; no unheld certifications are promised.
- Q:What if the audit line is idle?
- A:State the schedule honestly. Avoid 'model lines', but provide complete batch records for similar recent products as alternative evidence.
Figures sourced from:各国法规 · 欧盟CosIng 化妆品成分数据库配方库质检体系
Updated 2026-09-18
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