Considering the various departments within a company, one department plays a significant role in each: the quality assurance (QA) department. Quality assurance is the maintenance of a desired level of quality in every stage. QA is the last line of defense for a...
News & Blog
Environmental Monitoring, Keeping Your Rooms Ready
What is environmental monitoring? Environmental monitoring describes the systems that allow pharmaceutical manufacturers to monitor and control the viable, non-viable, and environmental contamination in their cleanrooms. The environment of manufacturing and...
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...
Quality Metrics – A Look at Your Company’s Health
It is always good to know how your company is doing. Whether monthly, quarterly, or yearly, company metrics are a great tool to determine what is working and what needs some work. What are metrics? A metric is a report that displays how your company is doing in every...
The Importance of New Perspectives in Continuous Improvement
My career in the BioScience/Pharmaceutical/Healthcare industry started at a company that manufactured blood plasma-derived therapies. These life-saving treatments were administered by intravenous injection to immunocompromised patients and during critical care...
Critical Aspects of Pharmaceutical Facilities and Equipment – Identification and Verification
This is the third in PSC’s series on Quality Risk Management (QRM) in Commissioning and Qualification (C&Q) following on the concepts introduced in the first two installments: QRM in C&Q Planning, and Risk Assessments – One Size Does Not Fit All. This week’s...
Why Electronic Document Routing is the Way to Go
When it comes to routing documents, whether it’s a new document, a revision, or a periodic review of the record, the process can be long and tedious. If your company is still using the printed paper version of routing, it may be time to step into the new world of...
Risk Assessment Methods – One Size Does Not Fit All
Risk assessment is a key competency for modern Pharma/Biopharma organizations. Since the publication of ICH Q9 “Quality Risk Management” in 2005, the use of both formal and informal risk assessment tools has become a critical activity and a focus of regulatory...
Reviewing Documents 101
When it comes to reviewing documents such as batch records, qualifications, validations, and other important documents, there are certain items that should be reviewed carefully. The reviewing of documents is a very important task within a company. Let’s take a...
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...
