Thursday, December 2, 2010

Batch Manufacturing Record Attachments

1.0    Purpose   :          To provide a documented procedure for Batch manufacturing record attachments.

2.0    Objective  :        To provide a guideline for Batch manufacturing record attachments.

3.0     Scope       :           This SOP is applicable for Batch manufacturing record attachments.

4.0      Responsibility  :
·           Primary     :  Production Chemist.
·           Secondary :  Production Officer.

5.0     Procedure :
·          Following attachments required to be attached to Batch Manufacturing Record before submitting the completed BMR to Quality Assurance.
Ø          Equipment clean record status label.
Ø          Equipment clean record.
Ø          Raw materials dispensed weighing slip.
Ø          Intermediate raw material sealed.
Ø          Transfer note for finished goods to F.G. store.
Ø           Raw material issue order (P.R).
Ø           IPQC- In Process Test Request Cum Report.
Ø           Excess material requisition (S.R.).
Ø           Deviation note if any.
Ø           Certificate Of Analysis (COA).
Ø           Finish product dispatch data.

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Subscribe to Quality Assurance and GMP by Email