PREPARATION AND ISSUE OF PRODUCT SPECIFICATION

1.0 PURPOSE:
To provide a procedure for Preparation and Authorisation of specifications.
2.0 SCOPE:
To make available specifications for RM / PM / Inprocess and Finished Products
3.0 RESPONSIBILITY:
Executive-Quality Control
4.0. ACCOUNTABILITY:
Manager- Quality Control
5.0. DEFINITIONS:
5.1. Specification is a authorised document describing the statutory requirements are prepared with reference of Pharmacopoeias or In-house parameters.
5.2. Release Specification: A document describing in detail In-house requirements( which have requirements additional to statutory requirements and limits of certain quality parameters more stringent than the statutory limits) with which the Intermediate product and finished product has to comply.
6.0. PROCEDURE:
6.1. There should be an authorised and dated specifications for raw materials and packing materials, intermediate, bulk and finished products
6.2. Specifications should be based on IP, BP, USP or In-house methods
6.3. Specifications are made based on availability of equipments, shop floor trials of PM, Stability studies of Raw materials and Finished products.
6.4. Specifications are developed and its master copy maintained by QA.
6.5. Specifications for raw materials and packing materials
6.5.1. A description of the materials including designated name and the internal code reference, and specimen of printed materials.
6.5.2. Qualitative and Quantitative requirements with acceptance limits
6.6. Specifications for Intermediate and bulk product
6.6.1. Specifications for Intermediate and bulk products should be prepared by identifying the critical parameters required for approval of further processing
6.7. Specification for finished products
6.7.1 Designated name of the product and code reference if applicable
6.7.2. The formula or reference to.
6.7.3. A description of Pharmaceutical form and package details
6.7.4. The qualitative and quantitative requirements with the acceptance limits.
6.7.5. The shelf life
7.0. REFERENCES:
7.1. PHARMACOPOEIA IP/BP/USP
7.2. SOP:QCGN:xxx
8.0. ENCLOSURES:
Nil
9.0. ABBREVIATIONS:
QA-Quality Assurance