GDP Audit Questionnaire

Beschreibung

You need to prepare for an audit or an inspection to come, a self-inspection or your own GDP audit of suppliers and subcontractors? The GDP Audit Questionnaire facilitates an efficient preparation, helps you save a lot of valuable time and ensures that the requirements are fully met! This questionnaire is a practice-oriented tool for preparing and implementing self-inspections with an emphasis on GDP (Good Distribution Practice). Compliance with GDP requirements during the product life cycle of medicinal products for human use, their active substances, and medical devices can be monitored, checked and directly documented using a list of questions. The questionnaire is aimed at companies involved in the distribution chain of healthcare products, including: - manufacturers of pharmaceutical and medical products - distributors of APIs - providers of logistics services - wholesalers and agents It can also be used when auditing service providers in this environment. The individual questions contain direct references to the following regulations: - EU GDP Guidelines on medicinal products for human use - EU GMP Guidelines - WHO TRS No. 957 (2010), Annex 5 - DIN EN ISO 13485:2016 These are the main topics of the questionnaire: I General questions for manufacturers of medicinal products and active pharmaceutical ingredients (API) II Manufacturing and testing of sterile products III Trade of active pharmaceutical ingredients (API) and excipients The GMP Audit Questionnaire works great for both sides - the auditor and the inspected company. It facilitates an efficient preparation for - an audit or an inspection to come - self-inspections - your own GMP audit of suppliers and subcontractors.

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