FDA, Guidance for Industry Process Validation: General Principles and Practices (2011) resource Agency Guidances OCEG Reviewed
Introduction: This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products.
FDA, Newly Added Guidance Documents - Drugs resource Agency Guidances OCEG Reviewed
Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.
FDA, Information for Industry (Drugs) Web Site resource OCEG Reviewed
The Food and Drug Administration's web site for topics of interest for business and industry regarding pharmaceuticals and over-the-counter drugs.
Drugs for Human Use (21 C.F.R. Part 300 et seq.) resource National Regulations OCEG Reviewed
Drugs; General (21 C.F.R. Part 200 et. seq.) resource National Regulations OCEG Reviewed
Food and Drug Administration Amendments Act of 2007, Public Law 11085 resource National Laws OCEG Reviewed
FDA, Frequently Asked Questions on Drug Development and Investigational New Drug Applications resource Agency Guidances OCEG Reviewed
FDA, Guidelines for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations (2006) resource Agency Guidances Member contributionOCEG Reviewed
Bristol-Myers Squibb : Compliance & Ethics resource Examples Member contributionOCEG Reviewed
The Bristol-Myers Squibb Compliance & Ethics web site. The site contains the following:
