EMPHASIZING PRODUCT QUALITY
Process & Cleaning Validation
Process & Cleaning Validation
Process Validation
cGMP Consulting Inc.’s team of engineers partners with clients to validate manufacturing processes, including, but not limited to:
- Bioreactor Processes
- Chemical Manufacturing Processes
- Aseptic Fill/Finish Processes
Industry standards emphasize process validation, approaching the entire manufacturing process using a holistic, lifecycle-based approach and prioritizing product quality. The goal of this approach ensures drug products consistently meet all relevant quality standards and expectations while also ensuring the product’s safety, effectiveness, and quality.
Our engineers approach each stage with an eye towards compliance with current regulatory and quality standards through robust data collection.
Cleaning Validation
Our processes assess toxicity, cleanability, batch sizes, and patient dose sizes based on industry-standard risk-based calculations.
cGMP Consulting’s engineers generate cleaning matrixes, assess cleanability for worst-case products, recommend cleaning agents, and develop the associated documentation to ensure that your company’s process complies and cross-contamination risks are controlled. cGMP Consulting Inc uses ultrasonic cleaners for semi-automated cleaning and Clean-In-Place (CIP) systems to qualify the following types of equipment:
- Ultrasonic cleaners with and without an integrated controls program for semi-automated cleaning
- Portable CIP Skids
- Compounding Fixed CIP Skids
- Parts Washers
