With regard to the acceptance of Third Party Audits, IPEC member Irwin Silverstein said "lawyer with both industry and FDA experience have been involved in developing the program and (that) nobody has raised a concern that the third party audit would present more of a problem than having your own people do the same audit". Similar third party programmes have already been established in other areas: ARC (Audit Repository Center), a PDA-associated company, offers auditing programmes for the audit of software suppliers, the IPEC (International Pharmaceutical Excipients Council) provides Third Party Auditing Programmes for excipient suppliers. This clearly states that third party audits are being accepted. Will Third-Party Audits Be Accepted by the Authorities?Īn audit is an important tool for evaluating the GMP compliance status.Ī frequently asked question in connection with the APIC Audit Programme is whether a third Party audit will be accepted by the authorities.Īccording to the draft Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Active Substances used as starting materials " it is expected that the holder of the manufacturing authorization will base such a declaration *) on carrying out, or having carried out on his behalf, an audit of the manufacturers/distributors of the active substances concerned."
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