Performance Validation

Performance Validation
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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...

Performance Validation

 •  October 27, 2017

Prior to starting commissioning and qualification activities, a plan should be developed. The plan may be commonly referred to as a Commissioning Plan, Commissioning and Qualification Plan, Qualification Plan or Validation Plan. The name changes based on the overall intent of the activity, but the documents all serve the same purpose – to help...

Performance Validation

 •  October 26, 2017

Data integrity demands a great amount of attention in the life science industry. This is now truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Audit trails for computerized systems are required for all FDA / EU regulated systems. It must capture the creation, modification,...

Performance Validation

 •  October 18, 2017

Buildings and equipment used in the manufacture, processing, packaging, holding or storage of drug product are subject to the regulations set forth by the FDA in 21 CFR Part 211. These regulations are considered the minimum current good manufacturing practices (cGMPs), for the manufacture of human and animal drug products. Commissioning and...