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This document applies to all manufacturers involved in aseptic processing of finished dosage forms (human and veterinary) as well as manufacturers of sterile labelled bulk drug substances (active pharmaceutical ingredients).

At the time of the issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence. The advice in this recommendation is not mandatory for the industry. However, the industry should consider this recommendation as appropriate.

This guideline describes the following points;

  • Process Simulation Test Procedures
  • Process Simulation Test Conditions
  • Interpretation Of Data
  • Environmental And Personnel Monitoring

 

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  • It is considered that the principles defined in the individual Recommendation documents can be applied equally in the manufacture of active pharmaceutical ingredients (APIs) and finished pharmaceuticals.
  • At the time of the issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence.
  • The advice in these Recommendations is not mandatory for the industry. However, the industry should consider these recommendations as appropriate.
  • It should be noted that additional requirements not contained in these Recommendations pertain to computer systems impacting GMP.
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In order to assure a harmonized conduct of inspections, with respect to the 2008 revision of GMP Annex 1 2
, this document summarises the interpretations which an inspector of the competent regulatory authority should adopt when performing an inspection of a manufacturer of sterile medicinal products.

This guideline describes the following points;

  • Definitions and abbreviations
  • New texts and their interpretation

 

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