SOP for Difference between Stability and Release Specification

OBJECTIVE

To lay down the procedure for the Assigning Stability and Release Specification.

SCOPE

This SOP is applicable to Assigning Stability and Release Specification.

RESPONSIBILITY

QC-Chemist

Head-QC

PROCEDURE

• A specification is a set of qualitative and/or quantitative qualities, as well as test procedures and acceptability limitations, to which a given product must conform.
• Only drug products have a shelf life and a release specification.
• Final Product Specifications (At Release) Monograph describing qualitative and quantitative features, as well as test processes and acceptability limitations, to which the finished product must conform at the time of manufacture (at its release).

• Final Product Specifications (Up to the End of Shelf Life) A monograph detailing the qualitative and quantitative features, as well as the test techniques and acceptance limitations, to which a pharmaceutical product (on the market) must adhere throughout its valid shelf life.

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• When it comes to release standards, they are more demanding. Compared to shelf life parameters, to provide more assurance to the applicant that the product will meet regulatory acceptance criteria throughout its shelf life. For example, in the case of a drug product, the shelf life specification is 90-110% w/w and the release specification is 95-105% w/w.
• This concept may only apply to internal criteria in Japan and the United States, not to regulatory release criteria.
• There is a regulatory obligation in the European Union for unique specifications for release and shelf-life if they differ.
• As per EU, the applicant, in compliance with Directive 65/65/EEC as amended, Article 9. a, shall adopt or refine the specifications at release as a function of experience acquired by the manufacturer(s) of the medicinal product.

• The specifications of the finished product at manufacture may be different from those of the medicinal product at expiry.

ABBREVIATIONS

QC: Quality Control

ANNEXURES

Nil

REVISION HISTORY

Nil

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