SOP for Preparation and Issuance of Data Sheet

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 PharmaInfo 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 and subsequent pages of Datasheets shall be prepared in the approved format on A-4 size paper 
• For Certificate of Analysis: If COA is applicable, shall be prepared in the approved format on A-4 size paper. 
• For detailed formats of data sheets (Front page, subsequent pages & Certificate of Analysis) Refer: to Annexure - 01 for Raw Materials, Annexure - 02 for Finished products (Tablets), Annexure - 03 For Finished Products (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 Datasheet shall have a unique number. Once the number is allocated to any Data sheet the same number shall not be repeated to any other Data sheet. 
• For datasheet number shall be as follows X/YYY 

ALSO READ: SOP for Preparation, Approval, Issue and Control of Work Sheets for Record of Analysis

Where, 

X refers to the product code for Product specific data sheet otherwise X refer to mentioned in the table

YYY- Refer to the serial no starting from 001 

• After initiation, Checking, and approval of the Datasheet, the Master copy shall be submitted to the QA documentation cell. 
• QA department shall issue a photocopy by stamping on each page as “CONTROLLED copy ” 
• Issuance record shall be maintained by giving the issuance number as follows XYY/NNNN 

Where,

ANNEXURE(s) 

REFERENCE

Nil. 

ABBREVIATION

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 

ALSO READ: SOP for Logbook Preparation