Include microbial and endotoxin risk
Consider microbial and endotoxin contamination when developing protocols.
CV-REQ-000007
EU GMP Annex 15: Qualification and Validation§ 10.7
TOPIC EXPLORER
Microbial Control
Considering microbial contamination alongside chemical residue risks.
1 connected reference
Practical guidance
PIC/S Publishes PI 006-4: A New Qualification and Validation Recommendation Takes Effect in October
PIC/S has published PI 006-4, the revised Recommendations on Qualification and Validation, superseding the 2007 PI 006-3 and entering into force on 1 October 2026. Cleaning validation now occupies a full chapter, with HBEL-driven scope, explicit limits on visual inspection and a clear position against continued test-until-clean practice.
ASTM E3470-25: Cleaning Risk Management Gets a Dedicated Method Standard
ASTM International has published E3470-25, a first-edition guide on using FMECA and HACCP/HARPC to identify, analyse and control risk in pharmaceutical and medical device cleaning processes. It is the method layer that E3106 required but did not fully specify.
When MACO Is Not Enough: What the Granules India Warning Letter Really Teaches
The FDA rejected a retrospective MACO argument in a February 2025 warning letter — not because the arithmetic was wrong, but because the cleaning it assumed had not been performed. What cleaning-validation teams can take from it.
When Shared Equipment Has Never Been Cleaning-Validated: Lessons From an FDA Warning Letter
An FDA Warning Letter to Indian API manufacturer Micro Orgo Chem describes non-dedicated equipment that had never been cleaned under a validated procedure, cleaning SOPs that were not followed, and no evidence that the rinse and swab samples required by the firm's own procedure were ever collected or tested.