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The draft guidance is available here.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As noted in the FDA announcement: This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities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
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 In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are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
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.
Performance Validation (PV) will be exhibiting at the Cutting Edge/Drug Discovery & Development symposium presented by MichBio on 12 November 2019 in Ann Arbor, MI.
John Underwood and Nicholas Fava will be representing Performance Validation and are looking forward to discussing validation and system compliance with you.… more
It’s October, the leaves are turning brown, Football season has started, Pumpkin Spice is everywhere, and before you know it, Winter will be here. Have you scheduled your Winter mapping Yet? Don’t miss out, Performance Validation is currently accepting bookings to schedule Winter Temperature Mapping.… more
PV Experience with the Kaye Advanced Validator System (Kaye AVS)
Performance Validation (PV) has had a validated Amphenol Kaye AVS system in our temperature mapping equipment inventory for about a year and has used it to complete several mapping projects by different Kaye users.… more
Performance Validation (PV) will be exhibiting in Booth 348 at the RAPS Regulatory Convergence 21-24 September 2019 in Philadelphia.
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