Batch Production Record

Sir, can you tell me please,

  1. How many pages should a BMR have? (My BMRs have at min. 30 pages and at max. 62)

  2. Should a BMR have described the cleaning record of the rooms and of the equipment in every stage, or we can include
    them all in a table at the beginning of the document?

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There is no specific limit of pages in a BMR it depends upon the length of the process and you can include the room cleaning record in line clearance checklist at the beginning of the document.


Thank you! You were very helpful to me!

There is no any requirement of the number of pages of the BMR.

Cleaning record of the room and the equipment detail is required, but you can consult your regulatory requirement which supporting document required for filling.

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BMR have no limit of pages.
Cleaning activity is mentioned in cleaning log book of every equipment. In line clearance check list cleaning checks are ensured by prd and q.a pharmacist.

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