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Audit Checklists

These convenient documents contain in-depth background information on planning and performing audits. The checklists navigate you through carrying out self-inspection and audits. The relevant section of the corresponding GMP or GDP guidelines appear next to each question.

Available as print and pdf downloads – excerpts from the GMP Compliance Adviser

Questionnaire for preparing GMP-inspections
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!

GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with reference to regulations on preparing for and carrying out Good Distribution Practice (GDP) audits

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