OBJECTIVE
To lay down a procedure for the Preparation, Numbering, Approval, Authorization, and Control, of Data Sheet for Raw Material (RM) and Finish Product (FP) including In Process, validation, Intermediate
SCOPE
This SOP shall be applicable for the preparation and control of Datasheet for Finished Products including in-process, and Raw material testing at XYZ Limited.
RESPONSIBILITY
Preparation : Chemist and above-QC Department
Checking : Asst. Manager and above-QC Department
Approval : Manger and his designee-QA Department
Issuance and control : Chemist and above QA documentation cell
PROCEDURE
- For data sheet preparation: The front page, subsequent pages of Data sheets shall be prepared on the approved format on A-4 size paper
- For Certificate of Analysis: If COA is applicable, shall be prepared on the approved format on A-4 size paper.
- For detail formats of data sheets (Front page, subsequent pages & Certificate of Analysis) Refer: Annexure - 01 for Raw Material, Annexure - 02 for Finished product (Tablets), Annexure - 03 For Finished Product (Capsules), Annexure - 04 for Finished Product (Liquid), Annexure - 05 for Finished Product (Dry Syrup), Annexure - 06 for Finished Product (Sachets), Annexure - 07 for Intermediate, In process and validation samples, Annexure - 08 for water testing sample, Annexure - 09 for swab sample and Annexure - 10 for Miscellaneous sample.
- Each Data sheet shall have a unique number. Once number is allocated to any Data sheet the same number shall not be repeated to any other Data sheet.
- For data sheet number shall be as follows X/YYY
Where,
X is refer to the product code for Product specific data sheet otherwise X refer as mention in the table
YYY- Refer to the serial no starting from 001
- After initiation, Checking, and approval of Data sheet, the Master copy shall be submitted to QA documentation cell.
- QA department shall issue a photocopy by stamping on each page as “CONTROLLED copy ”
- Issuance record shall be maintained by giving issuance number as follows XYY/NNNN
Where,
ANNEXURE(s)
REFERENCE(s)
Nil.
ABBREVIATION(s)
SOP : Standard Operating Procedure
No. : Number
Dept. : Department
Asst. : Assistant
A.R. No. : Analytical Report Number
STP : Standard Test Procedure
PM : Packaging Material
RM : Raw Material
FP : Finish Products
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