Stability Testing Protocol

STABILITY TESTING PROTOCOL

PRODUCT

BATCH NO.

BATCH SIZE

SHELF LIFE

DATED

1.0 PROTOCOL APPROVAL

Approval of this validation protocol will be joint responsibility of the following functional areas:

FUCTIONAL AREA NAME SIGNATURE DATE

QUALITY CONTROL

PRODUCTION

QUALITY ASSURANCE

FINAL APPROVAL

FUCTIONAL AREA NAME SIGNATURE DATE

MANAGER(QUALITY ASSURANCE)

2.0 OBJECTIVE

The purpose of stability studies is to provide evidence on how the quality of a product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light, and enables recommended storage conditions, retest periods, and shelf lives to be established.

? ICH – Q1A Guidelines on Stability testing of New Drug Substances and Products.

? WHO Guidelines for Stability testing of well established drug substances and their products.

3.0 SCOPE

This document provides guidelines for performing the stability studies (i.e. both accelerated and Real Time Study ), generating the stability data, collection, compiling and evaluation of the stability data . at .

4.0 RESPONSIBILITY

QC Officer / Executive

5.0 ACCOUNTABILITY

Head – Quality

6.0 PROCEDURE

6.1 Sample shall be collected for three consecutive batches of production initially for complete stability studies and thereafter one batch annually for real time stability study.

6.2 Any Manufacturing batch shall be subject to stability study for the single batch if any of the following changes has been made.

a. Change in suppliers for key ingredients

b. Change in the specified manufacturing process

c. Alternative site of manufacture of the product.

d. Change in primary packing

e. Change or replacement in the manufacturing equipment in case the operating principle is different.

6.3 The testing should cover those features susceptible to change during storage and likely to influence quality, safety, and/or efficacy. Stability information should cover as necessary the physical, chemical, and microbiological test characteristics.

6.4 The following books (pharmacopoeial monographs & manufacturing Specifications) shall be referred for any past established & compatibility studies of the Substance.

6.5 Selection of Batches

• The batches should be of the same manufacturing process and packed in the same container closure system as proposed for marketing or market pack.

• Samples of three consecutive batches of each pack will be subjected to complete stability studies and thereafter one batch annually for real time stability studies..

• Specifications: Stability studies should include testing of those attributes of the drug substance that are susceptible to change with storage and are likely to influence quality, safety and / or efficacy. The testing should cover: