Process Validation Procedures

Process Validation Procedures establish the controls required to validate the industrial processes. The framework provides a high degree of assurance that the process meets its pre-determined specifications and quality attributes. ADB Consulting’s comprehensive and systematic approach to process validation understands, mitigates and manages the risk associated with the process of manufacturing medical device and medical equipments.

At ADB, we design a strategic roadmap to complete three stages of process validation - process design, process qualification and continued process verification - in a timely and compliant manner. Our risk based approach monitor and control processes to determine the impact level of systems and equipment. The assessment evaluates the likelihood of failures, rejections, reworks, recalls and complaints. All the protocols and results are summarized to prepare final documentation that can be produced during litigation and audit trials.

Some of the processes for which ADB Consulting offers validation procedures include, but are not limited to the following:

·         Sterilization processes

·         Material handling and storage processes

·         Aseptic filling processes

·         Sterile packaging sealing processes

·         Welding processes

·         Lyophilization process

·         Heat treating processes

·         Plastic injection molding processes

·         Manual and numerical control cutting processes

·         Visual inspection of printed circuit boards

·         Manufacturing and testing of wiring harnesses

·         Cleaning processes

·         Certain human assembly processes

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