This article features:
- key determinants in validating manufacturing process;
- a mobile process validation app to completely document qualification protocol; and
- free process validation report templates you can download, customize, and use.
The FDA-issued Process Validation: General Principles and Practices is the current guidance for the manufacture of human and animal drug and biological products which aligns process validation activities with a product life cycle approach. An FDA investigative engineer shares that one of the major process validation problems encountered during inspections of US manufacturing facilities is the failure to demonstrate confidence in the process through proper documentation of qualification protocols such as:
To ensure that all specified design elements have been included and that the design meets the relevant regulatory and statutory requirements, the equipment qualification, also known as design qualification or final design against the user, and functional and/or design specifications should be verified. For adherence to Good Manufacturing Practices (GMP), the equipment at the manufacturing facility should be assessed for criticality according to its designated impact and risk priority.
The equipment/system should be installed correctly, supplied as specified, integrated into the manufacturing facility calibration and maintenance systems, and available for use. Supporting utilities should be described and deviations in wiring/cabling, power/fusing, input/output control, etc. should be recorded with a justification for acceptance and impact on operations. The installation qualification protocol should be signed off by the author and approved by the validation supervisor and quality assurance department.
The equipment/system should also be operating correctly, compliant with functionality requirements, and integrated into the manufacturing facility training system and Quality Management System (QMS). Calibration equipment, methods, and dates should be included with corresponding Standard Operating Procedures (SOPs); training records; and control point, alarm, and output results.
To ensure that the equipment/system is continuously meeting performance criteria for routine use in commercial production, the performance qualification should be verified. For equipment, the normal procedure for each use (configuration or load) should be run three times, and all required data should be recorded. Systems should run for 20 consecutive working days, and deviations to the procedure should be recorded. The acceptance criteria should be compared against the performance test results to formulate conclusions on the validity of the equipment/system.
iAuditor, the world’s most powerful inspection checklist app, can help manufacturing engineers, validation managers, and quality assurance personnel properly document process validation qualification protocols, monitor processes for consistent product quality, and ensure an ongoing demonstration of confidence in your manufacturing process. With the iAuditor mobile app, you can:
- Perform process validation with a mobile device. Request a demo.
- Capture photo evidence of the process validation procedure
- Take note of deviations and performance test results within the app
- Automatically generate and share process validation reports to members of your organization. Preview sample report.
- Use for free with small teams. Unlimited reports and storage for premium accounts. Compare pricing plans.
Top Process Validation Report Templates
Process Validation Protocol - Equipment Qualification Template
An equipment qualification template is used to complete the process validation protocol by reporting the verification of the equipment/system final design against the user, functional, and/or design specifications. Use this process validation protocol – equipment qualification template to easily identify key items of equipment, utilities supply, and environmental requirements. Take/attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc.
Process Validation Protocol - Installation Qualification Template
An installation qualification template is used to complete the process validation protocol by properly documenting that the equipment/system is correctly installed, supplied as specified, and integrated in the manufacturing facility calibration and maintenance systems. This process validation protocol – installation qualification template contains components checklist to make it easier for protocol authors to specify the component name, code no., function and area(s) of deviation, if any. Upon receipt of a piece of equipment from a supplier, quality assurance managers should use a Site Acceptance Test Checklist to validate its reliability.
Process Validation Protocol - Operational Qualification Template
An operational qualification template is used to complete the process validation protocol by recording all required data such as calibration equipment, training records, and user’s manuals and indicating the results from control points, alarms, and outputs. Easily define specific challenges of the equipment/system like normal conditions and worst case situations with the use of this process validation protocol – operational qualification template. Lab supervisors can also take advantage of a customizable Tablet Compression SOP Checklist to ensure that the correct steps are taken by lab personnel when using the tablet press.
Process Validation Protocol - Performance Qualification Template
A performance qualification template is used to complete the process validation protocol by detailing how the equipment/system is continuously meeting performance criteria for routine use in commercial production. This process validation protocol – performance qualification template describes a sample objective, scope, and responsibility to make it easier for validation managers to accurately proceed with the equipment/system run. Evaluate the acceptance criteria and performance test results, provide conclusions on the validity of the equipment/system, and gain departmental and quality assurance approval with the use of this template.