Audits/GAP Analysis

To identify the still existing gaps and deficiencies with view to international (EU / US/JAPAN) GMP-compliance standards. In addition, to help to prepare for the important inspections performed by the individual authorities (e.g. FDA/MHRA/EDQM/PMDA/MCC) 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 , Japanese ,USĀ  and rest of the world market place.
We conduct GMP audits/inspections to verify the compliance status of the manufacturer and suggest improvements. The types of audits that are covered here include gap analysis audits and mock inspections to assess the preparedness level for GMP inspections. This also supplements the internal self-inspection and expectations of the regulatory agencies of an independent audit of QA department by external agency

  1. GAP Analysis ( For WHO, USFDA, EU-GMP, EDQM, KFDA, MHRA, Schedule-M,
    State GMP, Health Canada, TGA, MCC, South Africa, PMDA, Japan)
  2. Types of Audits we conduct:
  • Internal audits (self-inspection)
  • Supplier audits (to make a supplier an approved supplier)
  • Customer / authority audits (inspection on site for compliance)
3. Audits for Quality System Compliance for the following manufactures:

  • Manufacturers of Active Pharmaceutical Ingredients ( API ) and
  • intermediates
  • Manufacturers of Finished Dosage Forms (
  • Manufacturers of Cosmetics
  • Manufacturers of Medical devices
  • Food manufacturers for food GMP and HACCP compliance
  • Excipient manufacturers and
  • Packaging material manufacturers

FACILITIES AUDITED / GAP ANALYSIS UNDERTAKEN:
Titan Laboratories, Anuh Pharma Limited, Cadila Healthcare Limited, Suchem Laboratories,
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