Supplier Qualification

In a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs.  As cited in the warning letter:

We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your other API suppliers [bold added] for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters.… more


Performance Validation, Inc. Acquires Welsh Commissioning Group, Inc.

INDIANAPOLISJan. 27, 2021 /PRNewswire/ — Performance Validation, Inc., an Indiana based company providing Commissioning, Qualification, and Validation Services to the Life Science Industries, has acquired 100% of the interests of the Welsh Commissioning Group, Inc. (WCG) headquartered in Auburn, Washington. … more


Artificial Intelligence and Machine Learning

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


ASTM E55

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:

E55_Newsletter_Issue10_Q4_2020_FINAL

Rick

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Insanitary Conditions

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


FDA Warning Letter to OTC Manufacturer

In a recently posted FDA warning letter to OTC Manufacturer, the OTC manufacturer in Canada received 6 observations.

This is one of the few warning letters where FDA calls out executive management for failure to provide oversight and control of drug manufacturing.
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Variation

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


Computer Software Assurance – Risk Assessment Takes Center Stage

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


Sage ERP Validation

Sage ERP Validation

The Challenge

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


Supply Chain

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