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32 Prepare FP Specification 032

The document describes the standard operating procedure for preparing finished product specifications at Oasis Laboratories Private Limited in Dehradun, India. It outlines that finished product specifications are developed according to pharmacopoeia literature and in-house specifications. Specifications are coded and stored in files and must be reviewed every three years or when test procedures are amended. The quality control department is responsible for specification preparation and the quality assurance manager approves specifications.

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ASHOK KUMAR LENKA
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529 views

32 Prepare FP Specification 032

The document describes the standard operating procedure for preparing finished product specifications at Oasis Laboratories Private Limited in Dehradun, India. It outlines that finished product specifications are developed according to pharmacopoeia literature and in-house specifications. Specifications are coded and stored in files and must be reviewed every three years or when test procedures are amended. The quality control department is responsible for specification preparation and the quality assurance manager approves specifications.

Uploaded by

ASHOK KUMAR LENKA
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN

SOP No.:
QCG 0032 QUALITY CONTROL DEPARTMENT Page 1 of 3

Supersedes : Effective Date:


STANDARD OPERATING PROCEDURE
00 April 2010
Version No. : PREPARE FINISH PRODUCT Review date:
01 SPECIFICATION March 2013

1.0 OBJECTIVE:

To describe the procedure for the Preparing Finish Product Specification.

2.0 SCOPE:

This SOP is applicable to Preparing Finish Product Specification...at


M/s. Oasis Laboratories Private Limited, Dehradun.

3.0 RESPONSIBILITY:

Quality Control Department.

4.0 ACCOUNTABILITY:

HOD QC

5.0 PROCEDURE:

5.1 Finished product are analyzed as per specifications described under


official pharmacopoeia and / or literatures & / or In house Spec.

5.2 Specifications of Finished product are coded as follow:


QC/STS/F/001 & QC/STP/F/001
Specifications of Bulk of Finished product is coded as follow:
QC/STS/B/001 & QC/STP/B/001

QC denotes quality control.


STS denotes for standard testing specification
STP denotes for standard testing procedure
F denotes for finish product
B denotes for bulk product
Designation Signature Date

Prepared by Chemist- QC

Reviewed by Manager- QC

Approved by Manager- QA
OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QCG 0032 QUALITY CONTROL DEPARTMENT Page 2 of 3

Supersedes : Effective Date:


STANDARD OPERATING PROCEDURE
00 April 2010
Version No. : PREPARE FINISH PRODUCT Review date:
01 SPECIFICATION March 2013

XXX denotes for the three digit serial number starting from 001

5.3 All finished product specifications must be reviewed every 3 years or


if any amendment to the tests or procedures are published or changed
by in house / other statutory requirements.

6.0 RECORD:

6.1 Specifications Finished product (Tablets) file.


6.2 Specifications Finished product (syrup) file

7.0 ANNEXURE:

Attached finish product format sheet.

8.0 ABBREVIATIONS & DEFINITIONS:

SOP : Standard Operating Procedure.


Dept. : Department.
HOD : Head of the Department.
QC : Quality Control

Designation Signature Date

Prepared by Chemist- QC

Reviewed by Manager- QC

Approved by Manager- QA

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