Performance Validation

Performance Validation
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Performance Validation

 •  October 18

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...

Performance Validation

 •  October 13

Today the pharma industry typically stick builds a new facility, installs permanent equipment, the financial guys max out depreciation, and when the product loses patent protection the cycle starts over. We have already seen some trends in biopharma that buck this trend. The use of single use systems which eliminates capital investment in...

Performance Validation

 •  September 26

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): Conducted more than 350 inspections of compounding...

Performance Validation

 •  September 18

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: An introduction...

Performance Validation

 •  September 13

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...

Performance Validation

 •  September 12

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. A summary of these citations include: Summary of critical...

Performance Validation

 •  August 29

As identified in the Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A concept of Operations published June 6, 2017 a for-cause facility inspection may be initiated: In response to a new registrant or a specific event or information that brings into question the compliance and/or quality of a manufacturing practice,...

Performance Validation

 •  August 24

In a recently posted warning letter to a compounding pharmacy based on an 8-page 483 that contained 13-observation was issued following an inspection (June –July 2-16) where the FDA was responding to a reported adverse event involving Chloral Hydrate. Examples of items identified during the FDA inspection and documented on the Form 483 include but...

Performance Validation

 •  August 23

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

 •  August 8

The FDA website posted the summary of their investigation into two serious adverse events associated with ImprimisRX’s compounded curcumin emulsion product for injection. The full summary is available on the FDA website, click here. The short version: Two patients were administered infusions of curcumin (a component of the spice tumeric)...