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
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
Several months ago we blogged about the use of digital sensors, to help monitor family members activity in and around the home, and the use of these digital sensors embedded in medication, basically a digital pill, to help monitor patient compliance in taking medication.… more
Saturday, November 4th, members of the Southeast Performance Validation Team participated in a wonderful opportunity – Habitat for Humanity. They spent the day learning about trusses, roofing, and design alongside members of the community as well as the future homeowners of the house!… more