Direct Links to important GMP Quality Control Guidelines

Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY

This note for guidance is intended to facilitate the collection and submission of data to support applications for marketing authorisation within the EEC for polypeptide based products derived by rDNA technology and intended for medicinal use in man. It concerns the application of Part 2, sections A-E of the Annex to Directive 75/318/EEC as amended, with a view to the granting of a marketing authorisation for a new medicinal product derived by rDNA technology.

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Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES

This note for guidance is intended to facilitate the collection and submission of data to support applications for marketing authorisation for cytokine products derived from biotechnological processes, particularly with respect to Part 2, sections A-E of the Annex to Directive 75/318/EEC as amended.

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Eudralex Volume 3 GUIDELINE ON ALLERGEN PRODUCTS: PRODUCTION AND QUALITY ISSUES

This document provides principles and guidance for the manufacturing and quality control of allergen products of biological origin, including allergen extracts from natural origin and allergens produced through recombinant DNA technology, used for specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE) mediated allergic diseases.

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WHO Good Manufacuring Practices for blood establishments

WHO requirements on the collection, processing an quality control of blood, blood components and plasma derivates

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APIC - Guideline for Qualification & Management of Contract Quality Control Laboratories

This document provides guidance for the management of contract laboratories.

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EU GMP Chapter 6: Quality Control

Quality Control

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GMP Conferences by Topics

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