GAP Analysis, pre-audit auditing, compliance audit
Purpose
To identify the still existing gaps and deficiencies with view to international (EU / US) GMP-compliance standards. In addition, to help to prepare for the important inspections performed by the individual authorities (e.g. FDA) or customers. In this case the audit is done as a mock inspection. Further on to prepare for customer audits and to help to find the way to the European or US market place.
Prerequisites
- Basic GMP system should be implemented and work
- Staff of the manufacturer should have been appropriately trained.
- Several batches of the product should have been produced according to relevant GMP requirements.
- Batch production documentation should be available
Procedures
- Discuss with client about their requirements (Signing of Secrecy Agreement recommended).
- Prepare an offer (fixed rate).
- Sign the contract and project commence.
- Send a checklist to receive first basic information about on-site situation (will be send via e-mail or by filling the check-list)
- Perform an on site 2-3 days auditing
- Prepare a final report
- Prepare a to-do list and give recommendations on improvements
- Follow up of improvements (via e-mail reporting)
- If requested a follow up audit can be done (based on separate charge)
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