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Regulatory compliance activities, such as Computer System Validation (CSV), can often be burdensome and challenging if they are approached without risk assessment. Often CSV deliverable completion is driven by procedures that are not designed to account for risk in relation to system, requirement, and processes. It tends to be a process focused more on documentation […]
Read MoreCommissioning and Qualification – An Overview
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 qualification of these […]
Read MoreCo-Manufacturing
In a recently posted warning letter, the manufacturer of over-the-counter (OTC) oral rinses and oral moisturizing drug products received a citation concerning 21 CFR 211.42. The firm used the same manufacturing equipment to manufacture the GMP over-the-counter oral rinses and oral moisturizing drug products and numerous non-pharmaceutical materials (Co-Manufacturing) in your facility, including an industrial car care […]
Read MorecGMPs for Outsourcing Facilities, Draft Rev 2
FDA has issued revision 2 to the cGMP Guidance for Outsourcing Facilities. The draft guidance is available here. And is open for public comment. As noted in the FDA announcement: This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities […]
Read MoreCGMP Consultants Recommended in FDA Warning Letters
In a review of the latest one hundred (100) FDA Warning Letters issued as of May 17, 2019, nineteen (19) included the section header “CGMP Consultants Recommended” within the content of the letter, followed by these statements: “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging consultants qualified as set forth […]
Read MoreCDRH – Recognized Standards
As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards. Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Excerpt from List […]
Read MoreDerek Fraits – Receives LEED Green Associate Certification
For Immediate Release (Indianapolis, Indiana; June 12, 2014). Performance Validation is pleased to announce that Mr. Derek Fraits has successfully completed certification as a LEED Green Associate. The Green Building Certification Institute administers this certification process. The LEED Green Associate credential is for professionals who want to demonstrate green building expertise in non-technical fields of […]
Read MoreAudit Trail Review – A Data Integrity Issue
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, […]
Read MoreAshley Saberniak receives ASQ CQIA Certification
For Immediate Release (Indianapolis, Indiana; March 4, 2016). Performance Validation is pleased to announce that Ms. Ashley Saberniak has successfully completed certification as a Certified Quality Improvement Associate. The Certified Quality Improvement Associate is a professional who understands quality tools and their uses and participates in quality improvement projects. The CQIA requries two years of work […]
Read MoreArtificial Intelligence and Machine Learning
In the world of commissioning, qualification, and validation for life science companies our world its pretty simple – you make a regulated product, you qualify the facility, the equipment, you validate the manufacturing process, and do change controls as necessary for equipment, facility, or process changes with updates to FDA depending on the magnitude of […]
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