Audits
GMP audit programme
Ofidit is the independent entity of Laboratorium Ofichem BV and is, within the Ofichem Group, specialized in performing GMP audits for third parties at API manufacturers located all over the world.
AUDITS IMPROVE THE QUALITY AND COMPLIANCE OF PRODUCTS
Each audit report includes an executive summary, recommendation, a list of non-compliance issues, as well as detailed comments on quality management, staff training, facilities, equipment, material management, production management, packaging and laboratory checks. For each subsection, a list of areas that were visited and revised documents are also provided.
The focus of each audit depends on the circumstances. In the case of multi-product equipment, for example, cross-contamination control and cleaning validation will be carefully assessed. For fermentation products, the microbiological purity of the broth would be an area of concern. In all cases, the protection of the integrity of analytical data is reviewed.
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