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.
more

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


Heparin – Once Again

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.

The warning letter for Yibin Liaho is available at the following link.… more


PV Michigan Office Relocation

On Friday February 21, 2020  the PV Michigan office will relocate to 5136 Lovers Lane, Suite 201, Portage, Michigan from their current location.  The phone number will remain the same (269) 373-9112.

Pictures of the new diggs and of the move to follow…

Rick… more


cGMPs for Outsourcing Facilities, Draft Rev 2

FDA has issued revision 2 to the cGMP Guidance for Outsourcing Facilities.

The draft guidance is available here. And is open for public comment.

As noted in the FDA announcement: This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations.… more