As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards. Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.… more
On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety:
The practice of compounding medicine can provide important public health opportunities.… more
A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections:
The citations to these two sections are illustated below for the past 5-years.… more
The Center for Drug Evaluation and Research (CDER) releases the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment.
This proposed guidance will address how CDER will informally recognize volunatry consensus standards.… more
Indianapolis IN – David McNish and Peter Bentley have been formally evaluated for demonstrated experience, knowledge, and performance in achieving an organizational objective through defining and overseeing projects and resources and is hereby bestowed the global credential of Project Management Professional (PMP)® by the Project Management Institute (PMI).… more
Milwaukee, Wis., — The Certification Board of ASQ (American Society for Quality) is pleased to announce that Mr. David Tebbe, that has completed the requirements to be named an ASQ-Certified Quality Engineer, or ASQ CQE.
David is a Senior Validation Engineer with Performance Validation, a 100% employee owned company which provides professional, technical services to the life science industry.… more
Performance Validation’s Critical Airflow Visualization Services Group has purchased an Applied Physics CRF4 cleanroom fogger. As noted in the above video [downloaded from Applied Physics USA], the CRF4 is a portable cleanroom fogger that can use deionized (DI) water or water for injection (WFI water) to generate 1.25 cubic meters of pure fog per minute at 170 ml fog density per minute to provide from 10 to 15 feet visible fog distance.… more
A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not related to product quality (e.g.… more
A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window.
Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their quality control lab facility, and changes to their utility systems to accommodate the resultant increased production rates.… more