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.
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
Officers / Executive – Quality Control shall be responsible for complies of this SOP
Manager – Quality Control and Head QA shall be accountability for complies of this SOP.
Format of specification Attachment-I
- 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.
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
- DISTRIBUTION LIST:
Quality Assurance department
Quality Control Department
10.0 HISTORY OF REVISION:
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