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

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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

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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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The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or
efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers, and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with
competent personnel, and suitable and sufficient premises, equipment, and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Authorised Person(s).

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This guideline describes questions and answers of Process Validation as per ASEAN guidelines like;

  1. Does this guideline also apply to biological/biotechnological products?
  2. For Option 2, should data related to Development Pharmaceutics be also submitted for generic products?
  3. For option 3, in the absence of pre-approval dossiers pertaining to process validation, would concurrent validation be acceptable?
  4. Are orphan drugs subjected to the full registration requirements? Using the concurrent approach, does it mean the product can be released for sale immediately after meeting quality requirements?
  5. Can Concurrent Validation be used for infrequently manufactured products? etc..
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Under 21 CFR 600.14, the manufacturer who holds the biologics license and who had control over the product when the deviation from current good manufacturing practice (CGMP), applicable regulations, applicable standards, or established specifications, or an unexpected or unforeseeable event (such a deviation or unexpected, unforeseen event is referred to hereafter as an “event”) that may affect the safety, purity, or potency occurred, must submit a report.

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