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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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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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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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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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This guideline describes the following points;

  • Annex 1 Manufacture Of Sterile Medicinal Products
  • Annex 2 Manufacture Of Biological Medicinal Substances And Products For Human Use
  • Annex 3 Manufacture Of Radiopharmaceuticals
  • Annex 4 Manufacture Of Veterinary Medicinal Products Other Than Immunologicals
  • Annex 5 Manufacture Of Immunological Veterinary Medical Products
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This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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