SOP on Retention of Records
1.0 Purpose: Purpose of this document is to describe a minimum period for retention of manufacturing and its related records.
2.0 Scope: This SOP applies to Production Staff and Quality Control Staff.
3.0 Responsibility: Quality Assurance Staff to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure:
5.01 All manufacturing and its related records are filed and stored at a safe place.
5.02 The access to these records is restricted.
5.03 All the records are easily retrievable.
5.04 According to the legal requirements under Drugs & Cosmetics Act 1940, these records are kept for a minimum of 5 years period from the date of manufacture.