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How
to Develop a
Validation Master Plan
HOW IS A VALIDATION MASTER PLAN DEVELOPED?
The plan is developed by taking into account the needs of the client, internal validation guidelines, internal product quality requirements, existing cGMP/GLP production utility equipment and the requirements of the FDA and Code of Federal Regulations (CFR). Manufacturing Automation Corporation develops the Validation Master Plan by first auditing the complete facility of the target company. Systems and documents to be audited are:
· Corporate Quality Plan
· Corporate Validation Guidelines
· Engineering Design Standards
· All GMP/GLP Validation Protocols
· All GMP/GLP production and laboratory equipment involved in the manufacturing of the regulated product, this includes all control systems, and related computer hardware and software systems.
· All GMP/GLP facility/utility systems that would have an effect on the research, manufacturing equipment, process, product quality or manufacturing repeatability such as Water for Injection, R.O./D.I., Clean in Place/SIP, HVAC, pure compressed air, steam and related control systems required to meet product quality, purity, containment and contamination requirements.
·
Corporate SOP’s are reviewed, as is engineering, maintenance, training and
other documentation
TO
CONTACT US
Phone:
908-369-3161
Fax: 908-369-1262
Email: rsickinger@mfgauto.com