Preparation of a validation master plan

A protective validation plan established for the entire project and summarizing all of the producer's views and methods ensures the adequacy of validation execution. It provides information on the validation work procedures and describes the time schedule for performing the validation and the identification of the responsibilities of the personnel involved.

Implementation of risk assessment

Failure Mode Effects Analysis (FMEA)or other risk assessment tools will be used to identify the effects of possible failures in critical components and functions and form the basis for the preparation of a validation program.

GMP Design Audit

GMP design audits are planned and systematic reviews of specifications,designs,design development and continuous improvement changes throughout the life cycle of a manufacturing system.The design review evaluates deliverables,identifies problems,and recommends necessary corrective actions based on standards and requirements.The documented results of the design review are the basis for any design modifications/additions.Successful GMP design reviews enable pharmaceutical companies to meet relevant GMP regulatory requirements and minimize the risk of drug manufacturing.