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SOP for Preparation of Data Sheet for Stability

OBJECTIVE
To lay down a procedure for preparation of data sheet for stability study of Drug Products

SCOPE
This SOP shall be applicable for preparation of data sheet for Stability Study of Drug Products manufactured at Pharmasky Limited.

RESPONSIBILITY
Implementation: Chemist and above Quality Control department.
Checking : Asst. Manager and above Quality Control department


PROCEDURE
  • Stability data sheet shall be prepared as per regulatory requirement.
  • Chemist and above in QC department shall prepare the respective data sheet for stability study as per annexure-1
  • All the data sheets shall be written in clear, unambiguous language, easy to understand and easy to follow.
  • Stability data sheet shall be prepared by Chemist, checked by other chemist and above, approved, by Head QC or his designee.
  • Each data sheet shall have a unique number. Once a number is allocated to any data sheet & the same number shall not be repeated to other data sheet.
  • For stability data sheet number shall be as follows.
AAA/B/CCC

Where:-
AAA = First three characters “SSD” indicates Stability Study data sheet.
B = Product code
CCC = Serial number started from 001
  • After initiation, approval and authorization of data sheet the master copy shall be submitted to documentation cell.
  • Documentation cell shall issue the photocopy of the master copy.
  • Maintain the issuance record of stability data sheets as per QCD041/A02-00. Issuance No. of Data sheet shall be given as follows,
X/Y/SC/ST
Where 
X Indicates the product code
Y Indicates the Batch No of the product
SC Indicates Storage condition
ST Indicates Station e.g 1M for 1 Month, 12M for 12 Month etc.

REFERENCE
Nil.


ABBREVIATION
SOP : Standard Operating Procedure
No. : Number
QC : Quality Control

ANNEXURE
Specimen Format of Data sheet for Stability study
Issuance Record of Stability data sheet

 
REVISION HISTORY
Nil

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