Ruchika Raval, President, Global BioPharm Regulations

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Situation as you join an organization • The supplier for a critical material is loosing their third party accreditation, your firm has assigned a good report card to date. You rely on paper questionnaire that they return back to your firm and the on time delivery to give this rank. The firm has been inspected on site four years ago. In the last year, their delivery has not been on time and you have over ordered to keep a stock available and not impact downtime. 6/14/2009 Ruchika Raval - Global Biopharmaceutical Inc. 26
…..In Review • The time to implement a supplier audit plan is during the late stage of clinical development • The biggest challenge for a start-up from a an oversight perspective is knowledge base to create a plan 6/14/2009 Ruchika Raval - Global Biopharmaceutical Inc. 27
Page 1 and 2: SoCalBio Regulatory Workshop Suppli
Page 3 and 4: Supplier and ISO 9000 and 13485 •
Page 5 and 6: Supplier and ISO 9000 and 13485 •
Page 7 and 8: Supplier and FDA Drug GMPs • that
Page 9 and 10: Supplier and ISO Q10 • 2.1 Manage
Page 11 and 12: Supplier and ISO Q10 • Defining t
Page 13 and 14: CONCEPT PAPER from the GMP INSPECTO
Page 15 and 16: Best Practice - Audit Preparation R
Page 17 and 18: Scenario 1 Sponsor is ABC Inc Combi
Page 19 and 20: On-Site • Review previous three r
Page 21 and 22: Audit Report • Scope • Review o
Page 23 and 24: Supplier Qualification Process Appl
Page 25: Situation as you join an organizati
Page 29 and 30: ….In Review When a firms connect
Page 31 and 32: ….In Review • An unbroken suppl

Ruchika Raval, President, Global BioPharm Regulations

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