Articles

When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a benefit to the intended patient or target animal; however, as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk. Hence, the presence of such contaminants should be managed according to the risk posed which in turn are related to levels that can be considered safe for all populations. To this end, health-based limits through
the derivation of a safe threshold value should be employed to identify the risks posed. The derivation of such a threshold value (e.g. permitted daily exposure (PDE) or threshold of toxicological concern (TTC) should be the result of a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data.

This guideline describes the following points;

  • Determination Of Health-Based Exposure Limits
  • Specific Considerations
  • Reporting Of The PDE Determination Strategy
  • Implementation
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This Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (“Inspection Guide”) lays down principles for GMP inspections of source plasma establishments and of source plasma warehouses. Most of the plasma imported to the EU or PIC/S Member States actually comes from the United States of America. Therefore, the Inspection Guide also takes into consideration the particular situation in U.S. facilities.

The Inspection Guide provides also basic information on GMP requirements, specific for source plasma establishments and for plasma warehouses. As in general the same GMP criteria are applicable for the storage of plasma in smaller facilities (e.g. a source plasma establishment with a freezer) and in bigger facilities (e.g. a central plasma warehouse with freezing rooms), the plasma storage requirements as defined in the Inspection Guide apply to both kind of facilities if not otherwise indicated. The document does not include plasma
testing.

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In order to ensure the maintaining of high standards of quality assurance and the integrity of the distribution processes of medicinal products, to promote uniformity in-licensing of wholesaling of medicinal products and to further facilitate the removal of barriers to trade in medicinal products, the following Guide to Good Distribution Practice (GDP) for Medicinal Products has been adopted.

Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good distribution practice should at least meet their level. These standards are also intended to serve wholesale distributors as a basis for the elaboration of specific rules adapted to their individual needs. It is recognized that there are acceptable methods, other than those described in this Guide, which is capable of achieving the principles of the Guide. This document provides guidance for preparation for inspections and may be used for training purposes.

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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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