FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -
Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

• 21 CFR 211.42(d): Separation of facility and equipment
• 21 CFR 211.46(d): Separate air handling systems (HVAC)
• 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.

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FDA Orange Book - Online

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Cross-Reference GLPs by FDA EPA and OECD (free)

If you ever had an interest or need to compare the GLPs (Good Laboratory Practices) across these three organizations, then you need to look at the FDA's "Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP." The information is organized in tables that cross-walk and cross-reference a particular row topic against the three columns for each organization. 

Here's what you'll be able to see:

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP - FDA.gov

Table of Contents

• Preface
• Scope and Authority
• Definitions
• Organization and Personnel
• Facilities
• Equipment
• Facility Operation
• Articles
• Protocol and Conduct
• Records and Reports
• Disqualification

Glossary: GLP = Good Laboratory Practice FDA = Food and Drug Administration EPA = Environmental Protection Agency OECD = Organisation for Economic Co-operation and Development 

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