preparation of master formula record
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for numbering system for master formula record (MFR).
2.0 SCOPE
2.1 This SOP is applicable for numbering system for master formula record (MFR)
3.0 RESPONSIBILITY
3.1 Officer–Quality assurance-Prepare the SOP and follow-up the SOP accordingly
3.2 Asst. manager –Quality assurance -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance / Chief Executive Officer
5.0 REFERENCE(S)
5.1 In-House
6.0 PROCEDURE:
6.1 Master formula record will be prepared by production department in approved format as per Format
6.2 After preparation of Master formula record production head shall check and send to QC for review.
6.3 QC head shall check and review and sent to QA for final approval.
6.4 Head – QA shall review and approved the master formula record and QA person shall put master copy stamp on top right corner of each page of MFR.
6.5 All the master copy of master formula records will be kept in QA department.
6.6 Master formula record number is an alphanumeric component document reference number.
6.7 Numbering system for Master formula record (MFR)
CN/MFR/YY/NNN-ZZ
Where:
CN : Company name
/ : For Separation
MFR : Master Formula Record
/ : For Separation
*YY : Product Code (e.g. D-5 = Dextrose 5%)
NNN : Serial Number of MFR
– : For Separation
ZZ : Revision Number for MFR (e.g. 00…01… etc.)
e.g.; CN/MFR/D-5/001-00,
* Product code may written in two to four digits
8.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control