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.

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.

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.

WHO Good Manufacuring Practices for blood establishments

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

Eudralex Volume 3 Guideline on plasma-derived medicinal products

This guideline provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention is given to the virus safety of these products.

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

This document provides guidance for the management of contract laboratories.

EU GMP Chapter 6: Quality Control

Quality Control

WHO Good Practices for research and development facilities of pharmaceutical products

This guideline is specifically applicable to research and development facilities of pharmaceutical products, procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, technology transfer-related activities (15), validation (7), quality control laboratory activities such as stability testing and development (16), and validation of cleaning procedures

WHO Guidelines for selecting marker substances of herbal origin for quality control of herbal medicines

The objective of this document is to provide selection criteria for marker substances of herbal origin for quality control of herbal medicines

Page 2 of 2