SOP for Preparing Finished Product Specification

OBJECTIVE

To describe the procedure for preparing the Finished Product Specification.

SCOPE

This SOP applies to preparing the Finished Product Specification at Pharmainfo Limited.

RESPONSIBILITY

Quality Control Department.

ACCOUNTABILITY

HOD – QC

PROCEDURE

• Finished products are analyzed as per specifications described under official pharmacopoeia and/or literature & / or in-house specifications.
• Specifications of Finished product are coded as follows: QC/STS/F/001 & QC/STP/F/001
• Specifications of the Bulk of the Finished product are coded as follows: QC/STS/B/001 & QC/STP/B/001

1. QC denotes quality control.
2. STS stands for standard testing specification
3. STP stands for standard testing procedure
4. F denotes for finished product
5. B denotes bulk product
6. XXX denotes for the three digit serial number starting from 001

• All finished product specifications must be reviewed every 3 years or if any amendments to the tests or procedures are published or changed by in-house/other statutory requirements.

RECORD

Specifications Finished product (Tablets) file.

Specifications Finished product (syrup) file

ANNEXURE

Finish product format sheet

ABBREVIATIONS

SOP: Standard Operating Procedure.

Dept. : Department.

HOD: Head of the Department.

QC: Quality Control

REVISION HISTORY

Nil

ALSO READ: SOP for Preparation of Certificate of Analysis (COA)