GMP Process Validation Consulting
Our team has extensive experience in both setting up and monitoring Process Validation programs. Process Validation has been a major focus of the FDA in recent years. Conferences in Berlin and Washington DC have reinforced and clarified regulatory expectations. This is an area where having the latest information makes all the difference. It is critical to begin thinking about Process Validation during the early stages of product development. Starting early will save your company potentially years in approval time to for your product. Let us help you set up a program or review your existing program for compliance with current industry trends.
Mtech is available to help evaluate the adequacy of your product, equipment, and facility. Our seasoned consultants provide expert, unbiased assessments that help ensure that strengths are leveraged and weaknesses are eliminated. These services include Programmatic Assistance, Validation/Qualification Activities, as well as Computer Systems Validation and 21CFR Part 11 Compliance reflecting our ability to deliver both strategic recommendations and tactical, front-line support.
We have expertise in providing consulting services for the following:
- Process Validation Master Plans
- Protocols and Reports
- Critical Parameter selection and studies
- Evaluation of small scale studies and their applicability to full scale work
- Methods validation and other QC support functions
- Support Studies required:
- Process Pool Hold Time Studies
- Buffer Hold Studies
- Product Specific Cleaning Validation
- Final Filter Validation
- Final Bulk Container Validation
- Shipping Validation
Programmatic Assistance
If you need help implementing or enhancing systems and/or processes, turn to the professionals at Mtech. With more than a decade of experience in validation and qualification, our consultants can guide you through development of:
- Validation/qualification policies, procedures, protocols, and master plans
- Technology transfer programs including processes, analytical methods, and changes
- Staff training for ongoing validation programs
- Program assessments
- Process simulation programs (i.e., aseptic processing media fills)
Validation/Qualification Activities
When you need help validating or qualifying specific systems and processes, turn to Mtech. We've helped clients ensure the quality and effectiveness of virtually every step and every support resource within the manufacturing process.
With our integrated blend of scientific, technical, and compliance expertise, we're your best choice for:
- Validating/qualifying computerized systems and electronic records
- Validating/qualifying manufacturing, packaging, and labeling processes
- Validating/qualifying cleaning, sanitation, and sterilization systems and processes
- Validating/qualifying facilities, critical utilities, and equipment
- Validating analytical methods
- Qualifying analytical equipment