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GDP Audit Questionnaire
€ 199.00
net
€ 236.81
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.
US$
230.00
pdf download
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

NEW: now also for active substances and modifiable!
editable Word file + pdf

Your perfect working tool: compact and practice-oriented!
NEW ++ NEW ++ NEW
Edition: second edition 06/2018
123 Pages
ISBN: 978-3-95807-108-7
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of GDP audits

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
The questionnaire contains the following chapter from the GMP Compliance Adviser:The GDP Questionnaire is your perfect working tool!

Click & View: GDP Audit Checklist

Technical Requirements

This file is in PDF and Microsoft Word format!
Filesize: 1,6 MB

To view PDF 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

Are you working with Word 2003 or older? Then you need a converter - for example, the Microsoft Office Compatibility Pack:
>>> Microsoft Converter - free download

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.
  • manufacturers of pharmaceutical and medical products,
  • distributors of APIs,
  • providers of logistics services,
  • wholesalers and agents.
Ferrante, Simone

Ms Ferrante is Head of Quality & Regulatory Affairs in the Grieshaber Logistics Group. As Quality Management Officer (QMO) and responsible person in accordance with GDP, she is also responsible for the entire Grieshaber Group. She is also an active member of a number of professional associations.

Previous editions:


1st edition 2013 | ISBN: 978-3-943267-81-5
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