Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification,...
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Get Your Cleanroom Ready for Business
When you think of a pharmaceutical or medical device company, cleanliness comes to mind when production comes to mind. Cleanrooms are a necessity when it comes to a company's production area. What is a cleanroom exactly? A cleanroom is a controlled environment used in...
Record Keeping and Documentation for GMP compliance
A company's records are a prized possession and should be taken care of the best way possible. When we think of good manufacturing practices (GMP), regulations must be followed to keep the quality and integrity of your records in good standing. Current GMP...
C&Q in Process Validation – Where Does It Fit In?
This is the fourth installment in PSC’s series on Quality Risk Management (QRM) in Commissioning and Qualification (C&Q). This follows on the concepts introduced in the first three installments: QRM in C&Q Planning, Risk Assessments – One Size Does Not Fit...
Process Solutions Flow Distribution in the Pharmaceutical/Medical Device Industries
Critical plant systems such as reverse osmosis and chemical distribution systems can bring production down when they go down. Over time plant utility usage can change, and previously reliable systems will have events that lead to production losses, regulatory...
Equipment Calibration – Keeping Your Equipment in Top Working Order
When thinking about the heart of the company, the equipment that produces your product must come to mind. Without good working equipment, your products may become compromised and hurt the company’s reputation for producing good quality products. Let’s say that during...
Applying Quality Risk Management (QRM) to C&Q Planning
Since the publication of ICH Q9 “Quality Risk Management,” applying the principles of Quality Risk Management (QRM) as part of Pharmaceutical Quality Systems is an expectation of global regulatory agencies. The effective application of QRM requires a significant...
ISO 17025 accreditation explained
Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the...
The Complete CQV: Where to Start
Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In...
Metrology 101
Why you need a calibration program Metrology is the scientific study of measurement. If you make things, you need to calibrate the buildings, equipment, and processes that you use to make things. If it moves or measures and doesn’t breathe, it might need calibration....