Increased Use of Third Party Audits For Improved

Increased Use of Third Party Audits For Improved Control Topic C Closing Presentation

Acceptance of n rd 3 Party Audit Excipient Manufacturers • • • Reduced site audits Reduced questionnaires 2 nd party auditors not always familiar with excipients • 3 rd party more consistent between auditors n n Do excipient manufacturers prepare more for 3 rd party audit? Negative first impression

Acceptance of n rd 3 Party Audit Pharmaceutical Manufacturers • Quality 3 rd Party Audit program • Excipient manufacturer specific Previously audited n Good Receiving and Production History n • Issues with supplier not passed to audit group • No regulatory issues to discuss-e. g. Residual Solvents

Acceptance of n rd 3 Party Audit Pharmaceutical Manufacturers • Audits of more excipient manufacturers • 3 rd Party auditor allowed more time onsite=more thorough assessment • Avoid risk management for deciding who to audit n FDA Position • Acceptable with proper controls

Acceptance of n n rd 3 Party Audit Types of audits: • Initial Qualification-2 nd or 3 rd party • For Cause-probably 2 nd party • Surveillance-preferably 3 rd party • Response to Regulatory Action-2 nd Party • Non-manufacturing scope-3 rd Party Consumers benefit from assurance of excipient conformance

Acceptance of n rd 3 Party Audit 3 rd Parties already being used for: • Packaging • Testing • Manufacturing n n Obstacle: Supplier Audit SOPs often preclude 3 rd Party Audit Security

3 rd Party Audit and Supplier Qualification n 3 rd party audit must be equivalent to 2 nd Party 3 rd party audit adds new perspective How do you handle serious adverse findings? • Who is notified of findings?

3 rd Party Audit and Supplier Qualification n Pharmaceutical firm must be able to action the report Excipient Audit of manufacturers with low volumes ISO 9001 certified program

Expectations of a 3 rd Party Audit Program n SOPs describing program operation • Pre-Audit Questionnaire • Established Audit Standard • Report Content n n n Confidentiality of audits Independent and unbiased organization and auditors Qualification and reputation of the organization and auditors

Expectations of a 3 rd Party Audit Program n n Qualify 3 rd Party Audit Program by comparing reports for same excipient Firm doing 3 rd Party Audit should not consult Mock or sample audit report Mechanism to confirm the veracity of the findings • Excipient manufacturer audit report review

Qualifications of the 3 rd Party Auditor n Training • General Audit ASQ Certified Quality Auditor n ISO 9001 Certified Lead Auditor n Recognized Auditor Training Course n • Excipient GMPs n Experience • Appropriate background including API n Understanding of regulated environment n

Qualifications of the 3 rd Party Auditor n n Knowledgeable on difference between 21 CFR Part 211 and USP General Information Chapter <1078> Prioritize/categorize audit observations • Know what is important to audit • Know what findings are important n Demonstrate audit competency

Benefits to Small Manufacturers n Pharmaceutical Manufacturers • Audit has more credibility than questionnaire n How do you know answers are truthful? • Small customers cannot audit excipient manufacturer • Avoid staff of auditors • Reduced number of audits especially outside the US. • Allows generics to assess more excipient producers

Benefits to Small Manufacturers n Excipient manufacturers • Audit helps assure their conformance

Closing Comments / Questions n n Web sites: Third Party Audits • WWW. IPEAINC. com • WWW. USP. org