This convenient document contains in-depth background information about planning for and carrying out audits. The questionnaire with more than 650 questions typically asked during audits or inspections, is arranged by subject-matter. Both parts of the book prepare you in an excellent way for audits (internally and externally) and inspections. The section of the corresponding GMP guidelines is quoted next to each question. This way the background of the question and possible answers can be easily researched in the original guidelines and laws. The questionnaire is a catalogue of typical general questions, which may be asked during an inspection. The questions are referenced to the corresponding GMP regulations. In cases of doubt, the relevant original text can be quickly found.
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 in active pharmaceutical ingredients (API) and excipients
You can find the complete table of contents in the reading sample.
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
- your own GMP audit of suppliers and subcontractors.
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- pharmaceutical manufacturers
Max Lazar looks back on an outstanding career within the pharmaceutical industry. For more than 35 years he was working with Hoffmann-La Roche. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7 Guidance. His more than 40-year career in the pharmaceutical industry includes numerous memberships in professional organisations and chairs of committees.
Oechslein, Dr. Christine
As a freelance GMP trainer, Christine Oechslein provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. She has worked in the pharmaceutical industry for many years. As a speaker for different event organisers and an author, she shares her GMP knowledge in the areas of process validation, GMP training and GMP in development.
Gotter, Dr. Bernhard
Bernhard Gotter took up the position of QA Manager in inspection management at F. Hoffmann-La Roche in 2016. In the previous five years, he had worked at Bayer in quality assurance, auditing, supplier management and project management. During this time, he managed numerous audits, and organised and supported official inspections.