More than 650 typical questions related to audits and inspections.Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.For auditors and manufacturers of drugs and APIs.NEW: Now modifiable!
for the Storage and Transport of PharmaceuticalsMore than 700 questions with reference to regulations on preparing for and carrying out Good Distribution Practice (GDP) audits
This report is a "must have" guidance for all those who are involved in qualification and validation: It provides information about regulatory requirements, risk management, life cycle concepts and much more. NEW ++ NEW ++ NEW
Excerpt from the GMP Compliance AdviserRequirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.NEW ++ NEW ++ NEW
Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Here you'll find a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.
Strategies for Successful Company-Wide ImplementationEvery page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.
Instructions for preparing a Site Master File according toPIC/S PE 008-4Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers.