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with the APIC Audit Programme is whether a third Party audit will be accepted by the authorities.Īccording to the draft Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Active Substances used as starting materials " it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." decreasing the frequency of audits when making the audit report available to pharmaceutical companies.standardised GMP audits of API manufacturers.The aims of The "APIC Audit Programme" are: The audits are conducted on the basis of the EC GMP Guide Part II/ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) with regard to the APIC Auditing Guide. who have signed a contract laying down the obligations as an auditor in the framework of the APIC Audit Programme.who have participated in recognised training courses/conferences on current GMP topics.who have completed an ICH Q7 compliance education course including an examination and a special APIC Auditor Training.The audits are conducted by APIC certified auditors release of audit report by experienced API specialists.standardised process for preparing audits.experienced and trained auditors that are registered as APIC certified auditors.There are three basic principles of the "APIC Audit Programme" for standardizing audits: *The costs for travel and accommodation as well as for the audit report will be charged additionally. Frequently asked questions and answers regarding the Third Party Audit programme can be found here. The participation in the "APIC Audit Programme" is on a voluntary basis and not limited to members of APIC. Mock Inspection/Audit: An API manufacturer wants to know if the company meets the ICH Q7 requirements. Shared Audit: Several customers (manufacturers of medicinal products) want to audit the manufacturing site of their API supplier. Third Party Audit: A single customer (manufacturer of medicinal products) wants to audit the manufacturing site of his API supplier. Read more here about the APIC Audit Programme - APIC Audit Step by Step It can also be initiated by an API manufacturer himself. when preparing for authority inspections. It is the aim of the APIC Audit Programme to offer an independent and 'turnkey' GMP Compliance audit of API manufacturers and/or distributors, including organizing, conducting and evaluating the audit.Īn 'APIC Audit' within the framework of the APIC Audit Programme can be initiated by one or more QPs from one or different manufacturing authorisation holders in order to get independent information about the GMP compliance status about the API supplier, e.g. The "APIC Audit Programme" is a third party audit programme for auditing API manufacturers, distributors and API contract manufacturers and/or contract laboratories. APIC Audit Programme What Is the "APIC Audit Programme?"
0 Comments
Leave a Reply. |