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 guide your team through the execution of the commissioning or qualification activities.… more
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.… more
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. … more
This summer Performance Validation, LLC engaged three interns from Rose-Hulman Institute of Technology to work with a PV project team at one of our Pharmaceutical clients in Illinois. The interns enjoyed a welcoming team environment where their contributions were appreciated and valued.… more
Winter is fast approaching in the US and soon there will be snow and ice covering the land! While nice for the holidays, those of us that are concerned about USP temperature controlled storage areas – winter brings with it the need to perform Winter Mapping. … more
January 2017, FDA released the FDA Compounding Progress Report which summarizes FDA activity in the compounding space in the 3 years following passage of the Drug Quality and Security Act. A PDF version of the report is available here.
A few highlights as of Nov 27, 2016 FDA has (p.10):
ASTM E55 Summer Newsletter is available and is posted on the ASTM website.
The ASTM E55 committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical and biopharmaceutical manufacturing industry. Topics in the ASTM E55 summer newsletter includes:
The week of September 4, 2017, Clarence Raiford a Senior Validation Engineer with Performance Validation conducted training on how to perform steam quality testing per HTM 2010, and EN 285 [available for purchase from various vendors]. The effectiveness of moist heat sterilization is dependent on three key quality parameters of the clean steam provided to the sterilizer:
Based on a review of FDA Form 483’s issued to compounding facilities for inspections that occurred January to July 2017, 22 separate citations have been identified for critical airflow visualization. Critical airflow is a key element in the protection of sterile product from contamination. … more