Direkt Links to important GMP Quality Control Guidelines

FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories, July 1993

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of quality control laboratories. The focal topic is the handling of out-of-specification analysis results

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FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 1993

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of microbiological QC laboratories. This guide supplements the Guide to Inspection of Pharmaceutical Quality Control Laboratories of July 1993 and goes into greater depth about the points an FDA inspector should check and inquire about in a microbiological laboratory.

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PIC/S GMP Guide for Blood Establishments (PE 005-3) Sept 2007

This document applies to blood and apheresis establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of human blood and blood components.

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WHO Good practices for pharmaceutical quality control laboratories

Requirements for national testing laboratories of authorities

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WHO Prequalification of quality control laboratories. Procedure for assessing the acceptability of quality control laboratories for use by United Nations agencies

Pre-Qualification of quality control laboratories for the United Nations

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WHO Quality control methods for medicinal plant materials

Quality control methods for medicinal plant materials

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PIC/S Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007

This document applies to laboratories for testing of the finished medicinal products, intermediates, starting materials for the production of medicinal products and in-process controls.

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FDA Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors

FDA now recommends implementation of quality assurance and quality control procedures that involve use of external control reagents beyond those provided by the test kit manufacturer in order to contribute to overall testing accuracy and therefore to blood safety.

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Eudralex Volume 3 Human cell-based medicinal products

This multidisciplinary guideline will address development, manufacturing and quality control as well as non-clinical and clinical development of cell-based medicinal products (CBMP) including somatic cell therapy medicinal products as defined in Directive 2001/83/EC, Part IV, Annex I1 and tissue engineered products as defined in Regulation 1394/2007/EC2.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE

This note includes information about species used for the production of animal immunoglobulin/immunoserum for human use as well as chracterisation of Immunoglobulin/Immunoserum, points to consider in manufacturing, final bulk batches, release testing and potentialvirus contaminations.

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GMP Conferences by Topics

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