Linta

Pharmaceuticals(PVT)Ltd
STANDARD OPERATING Document # Revision No. Effective Date Next Review On

PROCEDURE LP/ SOP/QC/001 00 21/June/2019 20/June2024

Page #
CHEMICAL ANALYSIS OF FINISHED PRODUCTS 1 of 6

Standard Operating Procedure

Of CHEMICAL ANALYSIS OF FINISHED PRODUCTS.
1

Author: Asmat ullah

(Quality control Analyst)

Reviewed By: Hina

(Quality Assurance Inspector)

Approved By: Muhammad Safdar Fatemi

(Manager QC/QA)

CONTROLLED COPY: No copying without management’s permission

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Author Reviewed By Approved By
 Linta
Pharmaceuticals(PVT)Ltd
STANDARD OPERATING Document # Revision No. Effective Date Next Review On

PROCEDURE LP/ SOP/QC/001 00 21/June/2019 20/June2024

Page #
CHEMICAL ANALYSIS OF FINISHED PRODUCTS 2 of 6

Table of Contents
2

1.0 AMMENDMENT 03

2.0 PURPOSE 04

3.0 SCOPE 04

4.0 RESPONSIBILITY 04

5.0 PROCEDURE 04

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 Linta
Pharmaceuticals(PVT)Ltd
STANDARD OPERATING Document # Revision No. Effective Date Next Review On

PROCEDURE LP/ SOP/QC/001 00 21/June/2019 20/June2024

Page #
CHEMICAL ANALYSIS OF FINISHED PRODUCTS 3 of 6

AMENDMENTS SHEET

Initiated Page 3
Rev. # Date Nature of amendment Done by
by #

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 Linta
Pharmaceuticals(PVT)Ltd
STANDARD OPERATING Document # Revision No. Effective Date Next Review On

PROCEDURE LP/ SOP/QC/001 00 21/June/2019 20/June2024

Page #
CHEMICAL ANALYSIS OF FINISHED PRODUCTS 4 of 6

1.0 PURPOSE
4
All these operations facilitate the quick release of products without the
error.

2.0 SCOPE

The document describes in details the requirements for the chemical

testing of finished product analysis. All these requirements must
comply with GMP (current Good Manufacturing Practice) and GLP
(current Good Laboratory Practice).

3.0 RESPONSIBILITY
 QC Analyst
 Assistant Manager QC
 QC Manager
4.0 PROCEDURE
4.1 The QA department is responsible to take the samples of
product from production department and will give the sample
to QC department.
4.2 The QC officer will receive the sample from QA and will check
the following information about the sample;
i. Name of the product
ii. Batch Number
iii. Mfg. Date
iv. Exp. Date

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Author Reviewed By Approved By
 Linta
Pharmaceuticals(PVT)Ltd
STANDARD OPERATING Document # Revision No. Effective Date Next Review On

PROCEDURE LP/ SOP/QC/001 00 21/June/2019 20/June2024

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CHEMICAL ANALYSIS OF FINISHED PRODUCTS 5 of 6

v. Batch Size
vi. Status
5
4.3 It is necessary to start the analysis only after ensuring all the
entries mentioned above.
4.4 All the samples will be kept in specified sampling trays.
4.5 The Laboratory Manager or the designated alternate will give
these samples to the analysts for analysis according to the
existing priorities. These priorities have to be determined by
the Laboratory Manager or his/her designated alternate.
4.6 All the analysts should analyze the products according to the
official control procedures.
4.7 The analytical results of each product should be entered into
the analytical work- sheets. These work sheets contain
specifications, which corresponds to the specifications given in
control procedures.
4.8 All the analytical data and results including chemical, IPC and
microbiological analysis should be checked by the QC
Manager.
4.9 After the decision, these worksheets should go to their
respective batch history files and be kept for five years in the
record room.
4.10 In case of non-conformity of test results, the analyst will
immediately inform the Laboratory Manager for the test failure.

CONTROLLED COPY: No copying without management’s permission

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Author Reviewed By Approved By
 Linta
Pharmaceuticals(PVT)Ltd
STANDARD OPERATING Document # Revision No. Effective Date Next Review On

PROCEDURE LP/ SOP/QC/001 00 21/June/2019 20/June2024

Page #
CHEMICAL ANALYSIS OF FINISHED PRODUCTS 6 of 6

4.11 All Laboratory activities must be described in written,

6
authorized procedures and appropriate record maintained.
4.12 After the analysis, the left over samples should be destroyed.
4.13 Laboratory must be maintained clean, tidy and safe condition
to meet requirement of GMP and GLP.

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