SOP on Specification Sheets for Raw Materials
1.0 Purpose: This SOP describes the requirements for preparation of a specification sheet for raw materials.
2.0 Scope: Specifications are required for each raw material used in manufacture of a drug product.
3.1 Sr. Production Chemist is responsible for setting specifications.
3.2 Quality Control Chemist is responsible for testing or assessing each material against set specifications before it can be released for use in production.
3.3 Quality Assurance Manager is responsible for approving the specifications and suppliers of material.
4.0 Materials and Equipment: None
Prepare a raw material specification sheet for each raw material from data provided –
Approved name of the product or any alternate name and in-house code number.
Indicate quality, or grade of product.
List specific characteristics to be tested including specifications.
List test procedure(s) to be used to determine if material meets specifications.
List of approved supplier and alternate suppliers, specific identification number.
6.0 Reporting: Provision of raw material specification list to purchase / receive department for ensuring that materials of correct quality are ordered from approved suppliers and that incoming materials are appropriately quarantined.