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GMP Manufacturing

A Successful Concept for Technology Transfer in Drug Manufacturing
€ 117.00
net
€ 139.23
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.
US$
135.00
pdf download
Excerpt from the GMP Compliance Adviser
Edition: First Edition, 12/2015
35 Pages
ISBN: 978-3-95807-026-4
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

There are currently very few mandatory requirements for transferring products to another manufacturing location. The WHO describes this transfer of technology as "a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites".

A product transfer is first and foremost a transfer of knowledge. The larger the volume of data and information provided to the contract manufacturer, the smaller the risk of unsuccessful attempts or failure of the transfer. Therefore, the documented knowledge and experience gained during development and manufacture should be passed on in a systematic way.

A Successful Concept for Technology Transfer in Drug Manufacturing covers all aspects you have to consider when transferring - including an example of a transfer plan you can directly work with!

The pdf download offers expert knowledge on
  • Transfer of information
  • Organisation
  • Risk Management
  • Technology transfer phases
  • Product transfer challenges
  • Areas of conflict during transfer
  • Quality of the product transfer
  • Example of a transfer plan
Order now your copy of A Successful Concept for Technology Transfer in Drug Manufacturing!

Technical Requirements

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Filesize: 1,5 MB

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  • Production
  • Engineering
  • Compliance Team
Gausepohl, Dr. Christian

Gausepohl is Head of the Quality Unit and a Qualified Person at Rottendorf Pharma. He has worked in many different positions and has extensive experience of carrying out audits and inspections for authorities, customers and suppliers. His main concern is the practical implementation of GMP requirements.

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