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.
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…
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The draft guidance is available here.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As noted in the FDA announcement: This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities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
Milwaukee, Wis., — The Certification Board of ASQ (American Society for Quality) is pleased to announce that Mr. Dakota Schmitt, has completed the requirements to be named an ASQ-Certified Quality Improvement Associate, or ASQ CQIA.
Dakota is a Validation Engineer with Performance Validation, a 100% employee owned company which provides professional, technical services to the life science industry. … more
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
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 In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are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
We are honored to announce Performance Validation is in the top ten percent of all recruiting companies in attracting and recruiting Rose-Hulman talent! As a top hiring company during the 2018-2019 academic year, PV played a vital role in providing internship and full-time offers to students from Rose-Hulman.… more
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.