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GMP Audits and Inspections

GMP Audit Checklist (Download)
Choose product version:
GMP Audit Checklist (Book) GMP Audit Checklist (Download)
€ 199.00
€ 236.81
  19% VAT included
for Pharmaceutical and API Manufacturers
138 Pages
ISBN: 978-3-943267-38-9
Excerpt from the GMP MANUAL

This convenient document contains in-depth background information about planning and carrying out audits. The checklist with more than 700 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 information sources include the 21 CFR 210/211/11 as well as the EU-GMP-Guide Parts I and II.

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

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

This file is in PDF format! To view these files, you need Adobe Reader installed on your computer. If you don't, you will need to download and install it.

>>> Adobe Reader - free download

- auditors
- pharmaceutical manufacturers
- suppliers
Preparing for the EU GMP Inspection
GMP Supplier Assessment Questionnaire
GDP Audit Checklist (Download)