Difference between Stability[Shelf life] Specification and Release Specification

1.0 OBJECTIVE 

To lay down the procedure for the Assigning Stability[Shelf life] Specification and Release Specification

2.0 SCOPE

This SOP is applicable to the Assigning Stability[Shelf life] Specification and Release Specification

3.0 BACKGROUND 

NIL

4.0 RESPONSIBILITY

4.1 QC-Chemist 

4.2 Head-QC

5.0 PROCEDURE

5.1 Specification is a Qualitative and/or quantitative characteristics with test procedures and acceptance limits, with which a given product must comply

5.2 Shelf life and Release specification is applicable only in Drug Products.

5.3 Specifications of the Finished Product (At Release) Monograph defining qualitative and quantitative characteristics with test procedures and their acceptance limits, with which the finished product must comply at the time of the manufacture (at its release).

5.4 Specifications of the Finished Product (Up to the End of Shelf life) Monograph defining qualitative and quantitative characteristics with test procedures and their acceptance limits, with which a medicinal product (on the market) must comply throughout its valid shelf life.

5.5 Release specifications are more stringent specifications when Compared to the Shelf life specifications to provide increased assurance to the applicant that the product will remain within the regulatory acceptance criterion throughout its shelf-life.

Eg: Assay of the Drug Product; Shelf life Specification is 90-110% W/W and release specification is 95-105% W/W.

5.6 In Japan and the United States, this concept may only be applicable to in-house criteria, and not to the regulatory release criteria. 

5.7 In the European Union there is a regulatory requirement for distinct specifications for release and for shelf-life where different.

5.8 As per EU, 3AQ11a the applicant, in compliance with Directive 65/65/EEC as amended, Article 9. a, shall adapt or refine the specifications at release as a function of experience acquired by the manufacturer(s) of the medicinal product.

5.9 The specifications of the finished product at manufacture may be different from those of the medicinal product at expiry.(Shelf Life)

6.0 ANNEXURES

Nil