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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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