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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
  1. Discuss with client about their requirements (Signing of Secrecy Agreement recommended).
  2. Prepare an offer (fixed rate).
  3. Sign the contract and project commence.
  4. Send a checklist to receive first basic information about on-site situation (will be send via e-mail or by filling the check-list)
  5. Perform an on site 2-3 days auditing
  6. Prepare a final report
  7. Prepare a to-do list and give recommendations on improvements
  8. Follow up of improvements (via e-mail reporting)
  9. If requested a follow up audit can be done (based on separate charge)


gemro Services ltd.
Address: Rms. 1106-7,
Kowloon Centre, 29-43
Ashley Rd., Tsim Sha Tsui,
Kowloon, Hong Kong
Tel: (852) 2317 5988
Inquiry: (86) 20-8736 5457
info@gemro-services.com