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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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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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This guidance applies to clinical trials regulated by HSA, namely:

(i) Clinical trials of Therapeutic Products that are subject to the requirements for a Clinical Trial Authorisation (CTA) or a Clinical Trial Notification (CTN);
(ii) Clinical trials of Medicinal Products (e.g. Cell, Tissue, and Gene Therapy Products; or Complementary Health Products) that are subject to the requirements of a Clinical Trial Certificate (CTC).

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The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA. Because the source
data2 are necessary for the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation (i.e., electronic records).

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This guidance provides recommendations on the following:

  • How to decide which adverse reactions or other potential safety hazards are significant enough to warrant inclusion in the warnings and precautions section; what information to include when describing those adverse reactions; and how to organize the warnings and precautions section.
  • What situations warrant a contraindication; what information to provide in those  situations when the use of the product is contraindicated; and how to organize the contraindications section
  • When to include a boxed warning; and what information to include in the boxed warning section

 

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