Spring Intro 2023

03/03/2023

• Manufacture (Manufacturer, Batch Formula, Description of Manufacturing Process/IPCs, Control of Critical Steps and Intermediates, Process Validation and/or Evaluation) • A flow chart and detailed description of the entire manufacturing process including in-process controls, addressing critical parameters not submitted. • No IPCs stated and/or wider tolerance specifications applied. • The importance of temperature not discussed and the chosen range not justified.  e.g. manufacturing process involves standard mixing with heat. The importance of temperature not discussed and the chosen range not justified. Common Deficiencies – 3.2.P.3

• A filter integrity test of the filter prior and after use is not stated. • No indication that bio-burden is controlled or no limit stated • Holding times not supported by data/data not submitted

03/03/2023

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• Manufacture (Manufacturer, Batch Formula, Description of Manufacturing Process/IPCs, Control of Critical Steps and Intermediates, Process Validation and/or Evaluation) • Critical parameters identified, but not included in the manufacturing process, e.g. conclusion of the process validation is that granulation time should not exceed X minutes, this should be specified in the manufacturing instructions in place of “granulate for an appropriate time”. Common Deficiencies – 3.2.P.3 (ctd.)

EMA/CHMP/QWP/245074/2015 - Guideline on manufacture of the finished dosage form of the finished dosage form

03/03/2023

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