SOP on Specification Sheets for Packaging Components
1.0 Purpose: This SOP describes the requirements for preparation of a specification sheet for packaging components.
2.0 Scope: Specifications are required for each packaging component (labels, cartons, shippers, pilfer-proof caps, bottles, foils etc) which comes in direct or indirect contact with drug during manufacture.
3.1 Sr. Production Chemist is responsible for setting the 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 specifications and suppliers of material.
4.0 Materials and Equipment: None
Prepare a packing material specification sheet for each material from data provided –
Approved name of product or any alternate name and in-house code number.
Indicate the 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 packing 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.