Excipient Auditing

Implementing GMP Auditing Practices for Excipient Suppliers July 30, 2001

Qualifying an Excipient Supplier ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Uniqueness of Excipients ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Where does GMP start? Review the scenarios and identify the processing point at which GMP principles should be applied. State your reasons as to why you feel this is the appropriate point to apply GMP.

Plant Site Chemistry Higher Vinylethers Methyl Vinylether GAFGARD 233 Maleic Anhydride GANTREZ AN Formaldehyde Methanol NEP Ethyl HEP Hydroxyethyl LP100 Octyl LP300 Dodecyl CHP Cyclohexyl Caprolactam ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],EVE n-BVE HBVE DVE-3 CHVE CVE PEPC DDVE EHVE GANTREZ S water ES 3351 IPA ES 225 ethanol ES 425/ES 435 butanol GANTREZ MS carbonates

Povidone Chemistry Formaldehyde Methanol ,[object Object],[object Object],[object Object],[object Object]

Assessing Excipient Supplier GMP Conformance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Reference Materials ,[object Object],[object Object],[object Object],[object Object],[object Object]

IPEC GMP Guide ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

IPEC Audit Guides ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

IPEC Audit Guide Manufacturer ,[object Object],[object Object],[object Object],[object Object]

Reconfirm Adherence to cGMP ,[object Object],[object Object],[object Object]

IPEC Audit Guide Distributor ,[object Object],[object Object],[object Object],[object Object],[object Object]

Traceable During Lifecycle Manufacture Distribution Pharm User Consumer

COA Issues ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

COA Content ,[object Object],[object Object],[object Object],[object Object],[object Object]

COA and Distributors ,[object Object],[object Object],[object Object]

Significant Change Definition ,[object Object],[object Object]

Significant Change Considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Significant Change Evaluation Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Significant Change Risk Levels ,[object Object],[object Object],[object Object]

Excipient GMP Audit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Auditing Techniques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Do Don’t

Audit Documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Audit Findings ,[object Object],[object Object],[object Object],[object Object]

Audit Report ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Auditor Etiquette ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

A. Company Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

B. Personnel ,[object Object],[object Object],[object Object],[object Object]

C. Quality Systems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

D. Management of Components ,[object Object],[object Object],[object Object],[object Object]

E. Facilities ,[object Object],[object Object],[object Object],[object Object],[object Object]

F. Warehousing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

G. Equipment (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

G. Equipment (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

G. Equipment (3) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

H. Production (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

H. Production (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Sugar Salt

I. Finished Product Management (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

I. Finished Product Management (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

J. Documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Excipient Auditing

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