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The Site Master File for Source Plasma Establishments (SMF – SPE) refers to the PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (PI 008) and should be read in close conjunction to it; relevant terminology can be found there. It is based on the information given in the PIC/S document PE 008.

The SMF – SPE should be completed by the manufacturer. In case of more than on choosing the correct boxes should be marked and missing entries should be filled in. Hand-written entries must be easily legible (use printed / block letters). Numerical data should refer to a calendar year.

In order to provide actual information the SMF – SPE should be completed not earlier than approximately six (6) weeks prior to the inspection

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The Site Master File for Plasma warehouses (SMF – PW) refers to the PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (PI 008) and should be read in close conjunction to it; relevant
terminology can be found there. It is based on the information given in the PIC/S document PE 008.

The SMF – PW should be completed by the manufacturer. In case of more than on choosing the correct boxes should be marked and missing entries should be filled in. Hand-written entries must be easily legible (use printed / block letters). Numerical data should refer to a calendar year.

In order to provide actual information the SMF – PW should be completed not earlier than approximately six (6) weeks prior to the inspection

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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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