PProcess and Cleaning Validation
Process validation is defined as establishing documented evidence that a specific process will reliably and consistently produce a product that meets its pre-determined specifications and quality attributes. Processes could encompass manufacturing, filling, sterilization, and packaging within the FDA regulated Pharmaceutical, Nutraceutical, API and Medical Device industries.
OUR MANUFACTURING PROCESS VALIDATION SERVICES INVOLVE A COMPREHENSIVE AND IN DEPTH EXPLORATION AND EVALUATION OF EVERY ASPECT OF THE MANUFACTURING ENVIRONMENT, INCLUDING BUT NOT LIMITED TO:
- Aseptic Processing Validation
- Environmental Baselines
- Liquids (sterile/non-sterile)
- Product Validation
- Tablets and Capsules
IN ALIGNMENT TO USFDA, OUR APPROACH TO PROCESS VALIDATION IS DIVED IN THREE STAGES:
Process Design: Our team will build up its knowledge through development and scale-up activities and come up with a defined commercial manufacturing process. Steps will be taken to establish a strategy for process control.
Process Qualification: The process design is then evaluated to determine if the process is well aligned and capable of reproducible commercial manufacturing. Facility design and qualification of equipment and utilities will be performed. Process performance qualification protocols will be developed and executed. Final report will be prepared and measures will be taken to get rid of any non-conformances and unexpected observations.
Continued Process Verification: Continuous process verification will be performed during routine production to ensure that the process remains in controlled state. Maintenance and calibration will be adjusted based on periodic assessments.
Please contact us for a more detailed approach and how can we help your organization.
We have adopted ICH Q9's Risk Assessment elements to Cleaning and Cleaning Validation for developing thorough, comprehensive and Risk-based Cleaning Validation Master Plans. We don't just "round up the usual suspects" (API, Cleaning Agent and Micro/Endotoxin) - instead we ensure that all potential hazards are identified and mitigated to provide the highest degree of patient safety by starting with a Hazard Identification to look for all potential chemical and microbiological hazards presented, the potential hazards presented by equipment and its design, and any potential failures from cleaning SOPs.
Our highly experienced staff is capable of developing and executing cleaning development and cleaning validation master plans and protocols to achieve desired results.