Get the free Certificate of GMP compliance of a manufacturer Application - Gov.mt

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APPLICATION FOR A CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER Apply I 006/04 Version 1 1 SECTION A: 1a APPLICANT INFORMATION NAME OF COMPANY 1b ADDRESS 1c ADDRESS OF SITE/S OF MANUFACTURE (if

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What is certificate of gmp compliance?

A certificate of GMP compliance is an official document that confirms that a manufacturing facility meets the good manufacturing practices (GMP) standards set by regulatory authorities.

Who is required to file certificate of gmp compliance?

Manufacturing facilities that produce pharmaceutical, biologic, or medical device products are required to file a certificate of GMP compliance.

How to fill out certificate of gmp compliance?

To fill out a certificate of GMP compliance, the manufacturing facility needs to provide information about their facility, personnel, quality control measures, and documentation related to GMP compliance.

What is the purpose of certificate of gmp compliance?

The purpose of a certificate of GMP compliance is to demonstrate that a manufacturing facility has implemented and adheres to the necessary quality control and manufacturing standards to ensure the safety, efficacy, and quality of pharmaceutical, biologic, or medical device products.

What information must be reported on certificate of gmp compliance?

The information reported on a certificate of GMP compliance includes details about the manufacturing facility, its address and contact information, the date of certification, a declaration of GMP compliance, and signatures of responsible personnel.

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