Direct Links to important GMP Biologic Guidelines

Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS

The quality issues, including biological safety, affecting biological active substances5 produced by the expression of one or more transgenes stably located in the genomes of higher plants constitute the scope of this guideline.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

The objective of this guideline is to provide broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells to be used to prepare biotechnological/biological products defined in Section 1.3, Scope, and for the preparation and characterisation of cell banks to be used for production. The document, therefore, provides recommendations on the information in these areas that should be presented in marketing applications for these products.

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Eudralex Volume 3 USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE

This document is concerned with the use of transgenic animals to produce biological pharmaceutical materials for use in human recipients. Transgenic animals may produce higher quantities of material in more concentrated form than existing culture methods, and therefore have considerable advantages in both the cost of producing the starting material and in its downstream processing.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)

The principles adopted and explained in this document apply to proteins and polypeptides, their derivatives, and products of which they are components (e.g., conjugates). These proteins and polypeptides are produced from recombinant or non-recombinant cell-culture expression systems and can be highly purified and characterised using an appropriate set of analytical procedures.

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Eudralex Volume 3 TESTS ON SAMPLES OF BIOLOGICAL ORIGIN

This document provides basic guidance on the presentation of data validating test procedures carried out for toxicological and pharmacological studies as well as for clinical trials provided for by Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation in respect of a medicinal product.

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Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES

This guideline addresses quality issues during demonstration of comparability for Similar Biological Medicinal Products containing recombinant DNA-derived proteins. As a consequence, the principles adopted and explained in this document apply to proteins and peptides, their derivatives and products of which they are components (e.g. conjugates). For other situations see Guideline on Similar Biological Medicinal Products, CHMP/437/04.

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Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS

The applicants of similar biological medicinal products, who have applied for scientific advice from the CHMP, expressed the need for specific guidance. The advances as well as the limitations of methods and techniques available today for the full characterization of such medicinal products have already prompted the CHMP to initiate a number of specific guidelines relevant to quality, non-clinical and clinical issues, to be addressed within the development programs of similar biological medicinal products.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS

The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Therefore, this guideline is intended to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product. The document does not prescribe any particular analytical, nonclinical or clinical strategy. The main emphasis of the document is on quality aspects.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES

This guideline gives advice to manufacturers and regulatory authorities to ensure that new combined vaccines and combined vaccines that are new to a particular manufacturer fulfil the highest possible standard of the quality, safety and efficacy.

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Eudralex Volume 3 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS

The guidance stated in this annex applies to well-characterised proteins and polypeptides,their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. Thus, the document covers the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony-stimulating factors, tumour necrosis factors),erythropoietins, plasminogen activators, blood plasma factors, growth hormones and growth factors, insulins, monoclonal antibodies, and vaccines consisting of well-characterised proteins or polypeptides.

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