Why do we Validate?

In a recently posted warning letter, FDA cited a drug manufacturer for failing to validate the manufacturing process for tablets.  FDA collected three samples during the inspection and laboratory results identified that all three were sub-potent for the active ingredient and one of the samples failed for content uniformity.… more


Quality Upset

Are you a 503B or Pharmaceutical Manufacturer regulated by USFDA or a 503A regulated by your State?

What do you do if/ when your API supplier is inspected by FDA, receives a 483, and warning letter?

Do you have a quality agreement in place that specifies notification of inspection results?… more


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


DeltaV Continuous Manufacturing Automation Qualification

The Challenge

A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the qualification of a suite of DeltaV automation modules that support continuous manufacturing facilities around the globe. The suite consisted of 38 DeltaV modules and phases that were interconnected and worked in tandem to automate the continuous manufacturing process.… more