SOP FOR PREPARATION OF SPECIFICATIONS

nirvesh400

1.0    OBJECTIVE:

To lay down a standard procedure for the preparation of specification for raw material, bulk product, semi finished product, finished product, packing material and water samples.

2.0   SCOPE:

This SOP is applicable for the preparation of specification for Raw material, Bulk Product, Semi Finished product, finished product, Packing material and Water Samples in Quality Control Department

3.0  RESPONSIBILITY:

Officers / Executive – Quality Control shall be responsible for complies of this SOP

4.0   ACCOUNTABILITY:

Manager – Quality Control and Head QA shall be accountability for complies of this SOP.

5.0   ATTACHMENTS:

         Format of specification                                                              Attachment-I

 

6.0   PROCEDURE:

 

  • Quality Control Department shall prepare the Specification as on approved format  for Raw Material, Bulk product, Semi Finished Product, Finished Product, Packing material and Water Sample Attachment-I.
  • The Tests and their Limits shall be clearly specified in the specifications.
  • The Specification shall be prepared by using reference pharmacopeia or other reference source.
  • Each Specification shall have a unique number. Once a number is allocated to any Specification the same number shall not be repeated to any other Specification.
  • After initiation and approval of Specification, the Master copy shall be submitted to QA for control and issuance.
  • All the specifications shall be reviewed whenever there is any change in pharmacopoeia or relevant source.
  • Any change in Specifications shall be done through change control procedure.
  • REFERENCES:

         In-house

  • ABBREVIATIONS:

         SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

  • DISTRIBUTION LIST:

         Quality Assurance department

Quality Control Department

10.0  HISTORY OF REVISION:

Version No.   Date of Revision Reason for Revision
00
01
02

 

 

STP