Gmp guideline

EU GMP Requirements

Good Manufacturing Practice (GMP) : the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use (Directives 2003/94/EC art. 2 no. 6, and 91/412/EEC art. 2)

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November 24th,2019

SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING …

3.1 This guideline focuses mainly on the overall concept of validation and is intended as a basic guide for use by GMP inspectors and manufacturers. It is not the intention to be prescriptive in specific validation requirements. This guide serves as a general guideline only.

November 24th,2019

GOOD MANUFACTURING PRACTICE GUIDELINE FOR …

and guidance tool to the Authority for GMP inspection and licensing of establishments. The requirement for establishment licensing is described in the guideline for establishment licensing. The guideline is a minimum requirement and as such does not restrict any new technological

November 24th,2019

GUIDELINES FOR CERTIFICATION UNDER WHO – GMP SCHEME

https://fdawhogmp.maharashtra.gov.in for Certification under WHO–GMP Guidelines Scheme on the letter head of the company, along with the Site Master File and other relevant data in the office of the Assistant Commissioner depending on the location of the factory. The fees should be remittedagainst each appliaction online

November 24th,2019

EudraLex The Rules Governing Medicinal Products in the …

the Commission to adopt and publish detailed guidelines on good manufacturing practice applicable to investigational medicinal products. 1.12. These Guidelines develop the GMP requirements that should be applied in the manufacturing of ATMPs that have been granted a marketing authorisation and of

November 24th,2019

WHO good manufacturing practices for pharmaceutical

The first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-first World Health Assembly under the title Draft requirements for good

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