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GMP Audits and Inspections

GMP Audit Checklist (Book)
Choose product version:
GMP Audit Checklist (Book) GMP Audit Checklist (Download)
€ 89.00
€ 95.23
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
The costs for shipping and handling depend on size and weight of the shipment and the destination country. They are individually shown in detail before finalization of the order.
spiral bound
for Pharmaceutical and API Manufacturers
Edition: 3rd edition 2013
138 Pages
Format: 210 x 155 mm

ISBN: 978-3-943267-66-2
Delivery: 2-5 business days after receipt of payment
Excerpt from the GMP MANUAL

This convenient document contains in-depth background information about planning and carrying out audits. In addition it contains a checklist with more than 700 questions typically asked during audits or inspections.
It is worth using checklists to deal with the questions that a GMP inspection may typically bring up. These can be considered carefully beforehand, e.g. which internal documents need to be kept at hand for a certain question – this will save some moments of panic during the inspection.

The checklist 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.
The references to German, European and American GMP-regulations reflect the status of the year 2013. Please note, that some amendments have been made to the EU GMP Guide since then. Therefore, some of those references may not be current.

The GMP Audit Checklist 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.

Click & View: GMP-Audit-Checklist
- auditors
- pharmaceutical manufacturers
- suppliers
Lazar, Max S.

FDA Regulatory Compliance Consulting, USA

Hiob, Dr. Michael

Ministry for Health of Land Schleswig-Holstein, Germany

Oechslein, Dr. Christine

GMP Instructor, Germany

Halfmann, Thomas

Halfmann Goetsch Partner AG, Switzerland

Preparing for the EU GMP Inspection
GDP Audit Checklist(Book)
GMP Supplier Assessment Questionnaire