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With the adoption of the ATMP regulation EC 1394/2007 ATMPs are regarded as medicinal products and must consequently comply with current EU drug legislation including GMP. Please find details at www. gmp-certification.eu Photo Courtesy Rentschler Biotechnologie Laupheim Germanyy Workshop on 12 October 2012 GMP for Advanced Therapy Medicinal Products ATMP Organisation and Contact GMP Certification Programme CONCEPT HEIDELBERG P. Are involved in ba...

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What is atmp gmp form?

The ATMP GMP form refers to the form used for reporting information related to Advanced Therapy Medicinal Products (ATMPs) that are subject to Good Manufacturing Practices (GMP).

Who is required to file atmp gmp form?

Manufacturers or sponsors of Advanced Therapy Medicinal Products (ATMPs) are required to file the ATMP GMP form.

How to fill out atmp gmp form?

The ATMP GMP form can be filled out electronically or manually. It requires providing detailed information about the manufacturing process, quality control measures, and compliance with GMP requirements.

What is the purpose of atmp gmp form?

The purpose of the ATMP GMP form is to ensure that manufacturers of Advanced Therapy Medicinal Products (ATMPs) comply with Good Manufacturing Practices (GMP) and maintain high standards of quality and safety.

What information must be reported on atmp gmp form?

The ATMP GMP form requires reporting information about the manufacturing process, including equipment used, personnel involved, quality control procedures, and documentation of compliance with GMP requirements.

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