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Inspection of sterility testing facilities and test methodology used by laboratories performing the sterility test for batch release of pharmaceutical products is incTrainingluded in the quality control activities checked by GMP inspectors.

This guideline describes the following points;

  • Training
  • Sterility Test Facilities
  • Sterility Test
  • Interpretation and Repeat Tests

 

 

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This guideline describes questions and answers on the implementation of risk-based prevention of cross-contamination in production and ‘guideline on setting health-based exposure limits for use in risk identification in The manufacture of different medicinal products in shared facilities’.

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The scope of this PIC/S Recommendation is limited to the following:

• The planning of routine GMP Inspections of active substance and medicinal product manufacturers by the Inspectorates of countries that are members of the PIC/S.
• The planning of routine GMP Inspections of Investigational Medicinal Product (IMP) manufacturers by the Inspectorates of countries that are members of the PIC/S.
• Follow-up activities, such as assigning a new risk rating to the site following the receipt of new information about the site or its products. (Note: this normally occurs between inspections and the types of new information might include information on quality defects, product recalls, market surveillance test results, etc.)

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has been set up in order to provide, in the interest of public health, for the cooperation between pharmaceutical inspectorates with a view to

  • fostering and maintaining mutual confidence;
  • promoting quality management system for inspectorates and best practices and standards in the field of inspections; and
  • contributing to global harmonization of standards of good manufacturing practice (GMP) for medicinal products, as defined in paragraph 7 of the Scheme (PIC/S 1/95 (Rev. 6)).
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These guidelines apply to distribution of active substances, for medicinal products for human use. An active substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action function or to make a medical diagnosis.

For the purpose of these guidelines, the distribution of active substances shall comprise all activities consisting of procuring, importing, holding, supplying or exporting active substances, apart from brokering.

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The manufacturing authorization holder is required to ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice (GMP) is. The appropriate GMP for excipients of medicinal products for human use shall be ascertained on the basis of a formalized risk assessment in accordance with these guidelines. The risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects.

The manufacturing authorization holder shall ensure that the appropriate GMP ascertained is applied. The manufacturing authorization holder shall document the measures taken. The excipient risk assessment/risk management procedure should be incorporated in the pharmaceutical quality system of the manufacturing authorization holder.

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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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