Manufacturing date

Quality Assurance
1

Hi, good morning.
Can you assign mfg date for the batch, a batch start up month.
Solid material mfg date can you assign a last completion of drying time/ month.
Mfg date can be millng month.

2

Manufacturing date for the batch is defined in internal SOP of the company. This is controlled by QA.
Following strategies are followed to define Manufacturing date for the batch.

  • Date of dispensing of the raw materials for the batch is a Manufacturing date.
  • Date of mixing of ingredients / raw materials in a mixer / mixing tank / Granulator is a Manufacturing date. )In case of Tablets, Capsules & Liquids, Injections, Creams etc.)
  • Date of charging of raw materials / components in a reactor in case of API is a manufacturing date
  • Date of Blending of different lots of API to make a “Blended batch” is a Manufacturing date of “Blended batch”.
  • In case of a “Re-processed batch” the date of reprocessing (first step) is the Manufacturing date.
3

Sir, thank you.

4

You are welcome…

5

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6

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