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 ensure the Safety, Integrity, Strength, Purity and Quality of the manufactured medicine. … more
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. … more
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.… more
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).… more
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.… more
For Immediate Release (Indianapolis, IN Nov 28, 2017) Congratulations to Mr. Mike Stires who was elected to the PDA Midwest Chapter board as a Member at Large. The PDA Midwest chapter board is responsible for the day to day operation of the chapter, and members at large, while members of the board, do not have specified duties but rather are assigned to serve on committees or undertake special projects at the direction of the chapter officers.… more
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 would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.… more
As reported by Inside Indiana – The former compliance director of Pharmakon, Caprice Bearden, has pleaded guilty to multiple federal charges, that include introducing adulterated drugs into interstate commerce and conspiracy to defraud the U.S.… more
Winter Temperature Mapping
The Winter season is fast approaching! USP guidelines require extreme seasonal temperature mappings to be performed where product temperatures are critical. PV can assist you in meeting your Winter temperature mapping needs.
Have you had increasing internal or external requests to demonstrate adequate temperature and/or humidity control within your facility?… more
A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration as well as reduce risk for human error when handling the product on fork trucks.… more