SOP on Batch Packaging Records

SOP on Batch Packaging Records
1.0 Purpose: This SOP describes the requirements / activities to be recorded during batch packaging in manufacture of a drug batch. 
2.0 Scope: This SOP applies to Production Chemist and operating staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: During packaging, following information is entered in batch packaging record as soon as each action is taken – 
1. Name of product.
2. Batch No.
3. Batch size.
4. Quantity released for packaging and date.
5. Date of packaging and quantity packed.
6. Calculation of total packaged yield.
7. Reconciliation of actual manufacturing yield.
8. Specimens of actual printed material used with appropriate information over printed.
9. Documentation of actual printed component usage records Vs packaging data.
10. Details of any over printing required (e.g. batch no., mfg. date, exp. date etc.)
11. Production chemist initials and date.
 
  

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