PYRAMID Laboratories Inc., Completes Another Successful FDA Inspection
FDA Comprehensive cGMP Inspection With No 483s.
COSTA MESA, Calif., April 9, 2018 /PRNewswire-iReach/ — PYRAMID Laboratories, Inc. (“PYRAMID”) is pleased to announce it successfully completed an unannounced nine-day comprehensive cGMP inspection of its manufacturing and laboratory facilities.
Medhat Gorgy, CEO and Founder of PYRAMID, stated, “Completing a two-week comprehensive inspection without any 483s being issued underlines the integrity of our quality systems and employee training programs, especially given that PYRAMID is committed to continuous improvement and actively expanding expertise and strengthening quality systems. This allows our Clients to trust PYRAMID to provide the highest quality standards and services for their sterile drug product development and manufacturing requirements.”
Three FDA inspectors, a lead inspector, accompanied by a microbiologist and a chemist, reviewed close to 600 documents and viewed live production activities. They performed a comprehensive inspection on quality systems, reviewing various operational processes and procedures including utilities; manufacturing process; media fills; batch records; equipment validation; analytical laboratory records, data review, and software compliance to 21 CFR Part 11; training records; material handling, and reporting and records management systems.
PYRAMID Laboratories, Inc. is an independent, premier service provider of cGMP contract development and sterile manufacturing services for the pharmaceutical, biotech, and medical device industries. PYRAMID specializes in contract manufacturing, analytical services, product development, formulation, fill/finish/lyophilization, and supporting laboratory services compliant with cGMP guidelines for all Phases of drug product development and supply from preclinical toxicology batches to commercial launch and supply. These services include formulation, processing, and filling capabilities for both vial and syringe applications.
PYRAMID’s newest expansion brings PYRAMID to a 90,000 sq. ft. facility.
Learn more about PYRAMID at www.pyramidlabs.com
PR Newswire press release
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