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Data integrityIn a recently posted warning letter a number of issues were identified concerning data integrity of laboratory results. These results included:Laboratory personnel used a software function “inhibit integration” without scientific justification. As identified in the warning letter: Inhibiting integration at various points during release testing for commercial batches is not scientifically justified. It can mask identification […]
Read MoreDakota Schmitt Receives ASQ CQIA Certification
Milwaukee, Wis., — The Certification Board of ASQ (American Society for Quality) is pleased to announce that Mr. Dakota Schmitt, has completed the requirements to be named an ASQ-Certified Quality Improvement Associate, or ASQ CQIA. Dakota is a Validation Engineer with Performance Validation, a 100% employee owned company which provides professional, technical services to the life […]
Read MoreCritical Airflow in Compounding Facilities
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: The design, construction, and operation […]
Read MoreComputer Software Assurance – Risk Assessment Takes Center Stage
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 […]
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