In the world of commissioning, qualification, and validation for life science companies our world its pretty simple – you make a regulated product, you qualify the facility, the equipment, you validate the manufacturing process, and do change controls as necessary for equipment, facility, or process changes with updates to FDA depending on the magnitude of the change.… more
Bryan Zylla and Rick Van Doel of Performance Validation are ASTM members and participate with ASTM Committee E55 Manufacture of Pharmaceutical and Biopharmaceutical products (among other ASTM committees). The fall newsletter from E55 provides an update on committee activities and is available for download at the following link:
FDA has released final approved guidance addressing Insanitary Conditions at Compounding Facilities. The guidance is available at this FDA link.
This guidance provides specific examples of insanitary conditions identified during FDA inspections of 503A and 503B facilities in section IIIA for both sterile and non-sterile compounding.… more
In a recently posted FDA warning letter to OTC Manufacturer, the OTC manufacturer in Canada received 6 observations.
Do you understand the sources of variation in your manufacturing processes?
As described the FDA Process Validation: General Principles and Practices, the manufacturer should use the product and process knowledge as a basis for establishing an approach to control that is appropriate for the manufacturing process.… more
Regulatory compliance activities, such as Computer System Validation (CSV), can often be burdensome and challenging if they are approached without risk assessment. Often CSV deliverable completion is driven by procedures that are not designed to account for risk in relation to system, requirement, and processes.… more
A medical supply company was audited and found their enterprise resource planning (ERP) software system Sage 100 needed to be validated since it creates quality records for the client. The customer used it only for Sales Orders and Vendor Purchases, so the entire software application did not need to be validated. … more
As a manufacturer of life saving drugs, how confident are you that your supply chain of API, intermediates, finished products, excipients, and other critical components necessary to manufacture your products can meet both today and your future needs?
Do you purchase from 1 supplier, do you have qualified backups that you could turn to if need be? … more
Heparin is once again in the FDA spotlight.
In a recent post by Zachary Brennan, another Chinese manufacturer, Yibin Lihao, was placed on import alert following an FDA inspection.