SOP FOR PREPARE MASTER PRODUCT SPECIFICATION
PURPOSE: To lay down a procedure for Preparation, Approval, Authorization of Master product specification.
SCOPE: This SOP is applicable for Production Block.
RESPONSIBILITY:
Preparation of SOPs: Officer QA Department
Checking and Review of the SOPs: Sr. Officer QA Department
Approval of the SOPs: Executive QA Department
Authorizing of SOP: Head QA/Designee
This Master Product specification (MPS) shall be prepared by QA officer/ Executive.
The MPS shall be checked by Production Head/ Designee and authorized by Head QA.
ACCOUNTABILITY: The accountability of implementation and ensuring compliance of the SOP lies with head of respective Department.
PROCEDURE:
Before preparation of any MPS the QA officer/ Executive shall collect following documents for collection of Data for that specific product.
QBD
Artwork specification
License detail
Customer Detail
All Data shall be put in respective format according to their dosage form.
All Formats shall be prepared electronically as per the instruction given in the format.
After preparation of MPS that shall be check by Production Head/Designee and undersigned the MPS.
The MPS shall be authorized by the Head QA and after that master copy will be prepared and kept with QA.
During issuance of BPR/BMR the MPS will be issued with it for clear information regarding the Product configuration.
MPS will be issued through following numbering system:
MPS/XXXX/YYY-NNNN
“MPS” Denote the Master Product specification.
“/” Denote the separation.
“XXXX” Denote the Customer First four characters.
“/” Denote the separation.
“YYY” Denote the product code.
“-” Denote the separation.
“NNNN” Denote the serial number.
QA shall maintain a MPS logbook with detail described.
REFERENCE:
SOP for SOP