Articles

Blood components are often used in life threatening situations of severely ill patients. Allied to this is a heightened public awareness and expectation of the quality and safety of these products. Therefore, high standards of quality and safety of blood components have to be assured. These high standards can only be achieved by applying the principles of GMP during the collection, preparation, storage, dispatch, quality control, and quality assurance of these products.

However, the implementation of GMP by blood establishments as well as the inspection of blood establishments by Competent Health Authorities is relatively new in many countries. It was considered by the PIC/S Blood Circle that a comprehensive GMP guide for blood components was missing and that as a consequence the implementation of GMP, as well as the harmonization of inspections, was impeded. Therefore, the PIC/S Blood Circle undertook in 1996 the task of drafting a specific GMP guide for blood establishments and blood
components.

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The adoption of ICH Q7 as the first truly harmonized GMP guideline for active pharmaceutical ingredients (APIs) and the associated development of regulatory frameworks to implement the guideline as a regulatory standard mark the beginning of a new era of regulation for medicines.

The adoption of ICH Q7 by PIC/S occurred in May 2001 with the current version of the guideline that has been available since 1 September 2007 as GMP PE 009 (Part II).

The primary objective for implementing ICH Q7 is the reduction of the risks associated with the manufacturing quality of APIs and this cannot be achieved without an effective inspection system that addresses the specific aspects of the global API industry.

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The process of packaging of medicinal products is listed among the risk factors that may affect the quality of the finished medicinal products and may also cause mix-ups.

The increased number of the defects of medicinal products occurred due to deficiencies in the process of labelling and packaging has drawn inspectors’ attention towards the need for identifying and clarifying the critical aspects of this specific stage of inspection, in order to have a uniform interpretation of the provisions of the current GMP guide concerning packaging of medicinal products
and prevention of mix-up.

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This Aide-Memoire should also contribute to a harmonized approach for inspection of shared facilities within the Pharmaceutical industry between the different PIC/S Members.

This Aide-Memoire may also be useful in support of inspector training but this is not its intended purpose and it should not be seen as a substitute for training and knowledge of an inspector.

Manufacturers of medicinal products must ensure that they are fit for their intended use, and do not place patients or target animals at risk due to inadequate safety, quality, or efficacy.

To reliably achieve the quality objective, a significant Good Manufacturing Practice (GMP) requirement is that manufacturers pay appropriate attention to those factors that present risks of cross-contamination of the products being manufactured with other materials handled on the site or facility.

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Technological and technical progress has increased in the pharmaceutical industry in the last decades. Progress has not only been made in the area of production equipment, technology, and quality control but also in the area of auxiliary systems such as HVAC and media systems.

PIC/S has paid due attention to these systems for the manufacture of medicinal products. In 2001, the annual PIC/S Seminar was devoted to the inspection of utilities used by the manufacturer of pharmaceuticals (Prague, Czech Republic).

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Inspections of sites involved in the testing of medicinal products should be more and more specific, thorough and conducted under normal working environment. These inspections may include a complete assessment of the laboratory’s conformance with the code of GMP or they may be limited to specific methodology or aspects of the laboratory. The inspection process of a laboratory involves the assessment of laboratory functions in full operation. Consequently, PIC/S has developed the Aide Memoires, which can be considered a good tool for enhancing the understanding and performance of inspectors.

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General GMP aspects and specific aspects for sterile biological medicinal products (Annex 1) and blood or plasma derived products (Annex 14) are not included in the aide memoires.

GMP aspects covering more stages in biotechnology manufacture, e.g. from cell banks to drug product, are presented in a general aide memoire in the “Specific biotech issues” section ahead of the more specific parts for the individual stages.

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Investigational medicinal products (IMP) must be produced in accordance with the principles and guidelines of Good Manufacturing Practices for Medicinal Products. This Guide to PIC/S Annex 13 is to be applied in addition to the applicable GMPs. In clinical trials, there may be added risk to participating subjects compared to patients
treated with marketed products. The application of GMPs to the manufacture of investigational medicinal products is intended to ensure that trial subjects are not placed at risk and that the results of clinical trials are unaffected by inadequate safety, quality or efficacy arising from unsatisfactory manufacture. It is also intended to ensure that there is consistency between batches of the same IMP used in the same or different clinical trials and that changes during the development of an IMP are adequately documented and justified.

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