PREPARATION AND ISSUE OF STANDARD TEST PROCEDURE

1.0. PURPOSE:
To provide a procedure for Preparation and Authorisation of Test Procedures

2.0. SCOPE:
To make available specifications for RM / PM / Inprocess and Finished Products

3.0. RESPONSIBILITY:
Quality control Chemist

4.0. ACCOUNTABILITY:
Manager- Quality Control

5.0. DEFINITIONS:
Standard test procedures are prepared for various General analytical test which includes Qualitative and Quantitative analysis.

6.0. PROCEDURE:

6.1. There should be an authorised and dated Standard Test Procedures for all raw materials and packing materials, intermediate, bulk and finished products.

6.2. STP should be based on IP, BP, USP or In-house methods.

6.3. STPs are made based on Pharmacopoes, manuals and other Reference books.

6.4. Standard Test Procedures are developed and approved by Manager-QA, Authorised by Manager –QC.

7.0. REFERENCES:
PHARMACOPOEIA IP/BP/USP

8.0. ENCLOSURES:
Nil

9.0. ABBREVIATIONS:
STP-Standard Test Procedure