Commissioning is a well planned, documented and managed approach to the start-up and turnover of facilities, systems and equipment to the end-user that results in an operational, safe, and functional system that meets established design requirements and end-user quality expectations.

Following current industry standards, such as ASTM E 2500 and those from ISPE, ProPharma Group can provide commissioning documents that verify proper installation, operation at start-up, functional performance, and turnover of facilities, systems and equipment. Our commissioning services include:

• Developing and executing commissioning plans that support the overall project schedule
• Developing commissioning documents (e.g. User Requirement Specification, inspection forms, Factory Acceptance Tests and Site Acceptance Tests)
• Inspecting for physical completion
• Vendor audits
• Witnessing vendor commissioning activities
• Managing the commissioning activities of vendors, construction contractors, owners, and contract resources.
• Executing commissioning activities for utility and process equipment systems in a manner that maximizes opportunities for leveraging with qualification activities.

ProPharma Group regularly develops both site Master Plans and project-specific Validation Master Plans. Our plans guide the entire project team toward the identified goals related to a facility that can be validated in compliance with all applicable regulations.

ProPharma Group is proficient in writing and performing Installation Qualification protocols to ensure that the equipment received is in good condition, as designed, and properly installed in the manufacturing environment.

We work together with our clients to develop and execute Operational Qualification protocols that ensure process equipment and ancillary systems are capable of operating within established limits and tolerances.

ProPharma Group validation consultants have extensive experience with performance qualification of facility systems such as HVAC, WFI, and process gas.