Full Description

Summary:

Defines procedures for validating and maintaining the validation of all aseptic filling processes (AFPs), as well as general content requirements for sterile media AFP Master Batch Records (MBR) and Part Number Specifications (PNS). Applies to all aseptically filled sterile products intended for human use. Does not apply to products that are terminally sterilized after filling. See also SOP 12-0015, QVD Protocol and Report Preparation and SOP 12-0020, MBR Document Preparation.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures