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Investigational medicinal products (IMP) must be produced in accordance with the principles and guidelines of Good Manufacturing Practices for Medicinal Products. This Guide to PIC/S Annex 13 is to be applied in addition to the applicable GMPs. In clinical trials, there may be added risk to participating subjects compared to patients
treated with marketed products. The application of GMPs to the manufacture of investigational medicinal products is intended to ensure that trial subjects are not placed at risk and that the results of clinical trials are unaffected by inadequate safety, quality or efficacy arising from unsatisfactory manufacture. It is also intended to ensure that there is consistency between batches of the same IMP used in the same or different clinical trials and that changes during the development of an IMP are adequately documented and justified.

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Quality risk management is a systematic process for the assessment, control, communication, and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation (MA) 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 the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance (QA) incorporating Good Manufacturing Practice (GMP), and thus Quality
Control (QC) and Quality Risk Management (QRM). It should be fully documented and its effectiveness monitored.

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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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Harmonization will help ensure that there is a consistent view across inspectorates of what constitutes a “Critical” deficiency and what constitutes a “Major” deficiency. Risk management principles will be applied to the
categorisation of these deficiencies dependent on the type of product manufactured or process. The reference in the relevant code of Good Manufacturing Practice or local legislation should be established for each
deficiency to ensure that a reported deficiency has a regulatory basis and is accurately applied.

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this guideline describes questions and answers like;

  1. Are Health-Based Exposure Limits (HBELs) required for all medicinal products?
  2. Is there a framework that could be used to define the significance of the Health-Based Exposure Limit (HBEL) such that there can be broad guidance on the extent of Quality Risk Management (QRM) and control measures required?
  3. How should manufacturers use the HBELs?
  4. What competencies are required for the person developing the HealthBased Exposure Limits (HBEL)?
  5. What responsibility do contract givers have to contract manufacturers in relation to data to support a HBEL assessment?
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