Compliance Services
We provide personnel to develop and execute the required documentation to achieve full compliance of your GMP manufacturing facilities and systems. Commissioning is performed as an engineering quality assurance activity and will support the validation activities by reducing duplication of efforts and identifying problems early. Our qualification will focus on the installation, operational, and performance attributes with critical product impact. We can develop the protocols to perform all necessary testing to establish validation of such processes as automated cleaning, sterilization cycles, and manufacturing processes, and can assist you in the development of a test and sampling plan, statistically analyze process capability, and determine a basis for routine monitoring.
The primary areas where we can be of assistance:
Validation Project Planning and Project Management Meeting project schedule goals and controlling costs are the result of good project planning and management. We will outline the strategy for qualification and commissioning, establish relationships for systems and documentation and facilitate management of risk. We utilize scheduling and reporting tools to track progress and communicate road blocks or hold ups.
Facility/System Commissioning Commissioning supports the validation activities by reducing duplication of efforts and identifying problems early. Our commissioning process involves assembling supporting documentation and drawings, receipt verification, installation verification, and functional checks.
System Qualification We can qualify systems through the execution of IQ, OQ, and PQ protocols. Protocols will focus on critical attributes for the system installation, operational, and performance.
Validation of Cleaning, Sterilization, & Manufacturing Processes We can develop the protocols to perform all necessary testing to establish validation of cleaning, sterilization, and product manufacturing processes in accordance with specification criteria. We will work to develop a test and sampling plan of the operational parameters, gather data, statistically analyze process capability, and determine a basis for routine monitoring.
Control System Qualification Our approach is to work with your supplier to support the qualification, making as much use of their internal quality system as the basis for IQ, OQ, and PQ documentation. User requirements, system and functional specifications are developed and incorporated into the necessary test scripts.
Part 11 Compliance We can analyze CFR 21 Part 11 implicated systems finding gaps in compliance, and propose the necessary strategy to bring systems into compliance. We can validate electronic records and electronic signature functions of information systems and control systems as part of the validation efforts.
SOP Creation and Operations Support Our consultants can help by developing standard operating procedures, evaluating batch record documentation for compliance with cGMP documentation standards, assist in resolving corrective action/preventive action issues, or support process validation efforts.
Process Capability and Six Sigma We can assist with the use of statistically valid techniques such as screening experiments to establish key process parameters and statistically design experiments to optimize the process as part of OQ or Process Validation. We provide the tools for ensuring the studies cover process capability across the identified parameter limits and use statistical control methods to fully evaluate the process.
