Critical Airflow in Compounding Pharmacies

Analysis of 109 FDA Form 483’s issued to Compounding Pharmacies in 2018 was performed. A textual analysis for the term SMOKE identified approximately 1/3 of the facilities (34) received an observation associated with Critical Airflow Visualization or as commonly referred to as Smoke Studies.

CDRH – Recognized Standards

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

FDA Funding

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

21 CFR 211.42 – Buildings and Facilities

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:

  • 21 CFR 211.42(c)(iv) A system for monitoring environmental conditions;
  • 21 CFR 211.42(c)(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

The citations to these two sections are illustated below for the past 5-years.… more

Consensus Standards

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Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment.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

PV Staff Earn Project Management Professional Certification

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

David Tebbe Receives ASQ Certified Quality Engineer

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

New CRF4 Fogger

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

Deblistering Machine Qualification


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

Qualification of Cell Culture Purification Suite

The Challenge

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