Performance Validation

Performance Validation
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Performance Validation

 •  January 24

A leading medical device manufacturer introduced a new production line to their assembly facility. The new line was designed to accommodate the simultaneous production of several makes and models of hand-held motor-driven surgical devices. This new line was designed to apply the latest integrated manufacturing technology to optimize flexibility,...

Performance Validation

 •  January 23

(Indianapolis, Indiana, January 2018) Performance Validation (PV) will be attending and exhibiting at the PDA Midwest February 2018 Dinner Meeting. At this meeting there will be a networking opportunity and Dr. Tony Cundell will be presenting information concerning USP Chapter updates. The meeting will be held on February 15, 2018 from 5:00 to...

Performance Validation

 •  January 19

January 2018, FDA Commissioner Scott Gottlieb issued the FDA 2018 Compounding Policy Priorities Plan on the FDA website. This communication provides a summary background on how the FDA became involved in compounding pharmacies, and a summary of how FDA will prioritize actions to protect the public health as obligated under DQSA. I found the...

Performance Validation

 •  December 29, 2017

The 2017 FY FDA inspection summary has been published to the FDA website. you may download the FY 2017 Excel File from the following link. This file contains a summary of FDA Form 483 data for inspections ending between 10/1/2016 and 9/30/2017 and is a great tool to evaluate the various citations observed from various FDA inspections. The below...

Performance Validation

 •  December 29, 2017

Why are we concerned with Quality Risk Management (QRM) when planning, developing, and executing commissioning, qualification, and validation work? The simple answer is time and money. Pharmaceutical companies are under pressure to bring new therapies to market quicker and to do so at less cost, while still meeting the mandates of cGMPs which...

Performance Validation

 •  December 21, 2017

Recent research published by the University of Warwick (2017), describes a new algorithm that can predict the interactions between a protein and a drug molecule based on a limited number of actual experiments (AI and drug development). The algorithm can predict with a 99% accuracy if a drug molecule will bind to a target protein. The application...

Performance Validation

 •  December 17, 2017

21 CFR 211.192 requires a thorough review of any unexplained discrepancy whether or not the batch has been distributed. Lack of / or poor Alarm management was identified by the FDA during an inspection of a 503B Outsourcing Facility (Observation 2, Form 483). The firms Building Maintenance System had logged ~766 alarms since March 8, 2016 (the...

Performance Validation

 •  December 12, 2017

In a recently posted FDA Warning Letter, USFDA provided a clear expectation concerning the purpose of validation: The purpose of validation is to determine whether your processes can operate within established parameters to assure consistent batch uniformity, integrity, and drug quality. Reliable and well-documented batch operations are essential...

Performance Validation

 •  December 6, 2017

The Office of Pharmaceutical Quality (established by USFDA), this new office was established in January 2015 with a a mission to assure that quality medicines are available for the American public. As stated in the OPQ FDA Website OPQ combines non-enforcement-related drug quality work into one super-office, creating one quality voice and improving...

Performance Validation

 •  November 22, 2017

The cGMPs are pretty explicit when it comes to equipment used in the manufacturing, holding, and packaging of drugs. 21 CFR 211.67(a) states that equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that...