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

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The draft guidance is available here.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As noted in the FDA announcement: This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities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


Outsourcing?

Survey responses in the Dec 19, 2019 Aspen Alert identified that 83% of the survey respondents would utilize 3rd party resources to support their facilities in the upcoming year:

 

 

 

 

 

 

 

 

Performance Validation’s core business is providing commissioning, qualification and validation services to the pharmaceutical, biotech, and medical device industries.… more


Importation of Drugs

Notice of proposed rulemaking (NPRM) issued Dec 18, that if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.… more


Seasons Greetings from Performance Validation

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Why do we have drug shortages?

In a recent post by FDA, Janet Woodcock – the primary reason for drug shortages are because of either manufacturing or quality related issues.

All drug manufacturers that sell their medications in the United States must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) requirements.

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