PYRAMID Laboratories Inc., Completes Successful FDA Audit
Second Consecutive FDA Audit Without Observations
Costa Mesa, CA /PRNewswire-iReach/ - PYRAMID Laboratories, Inc., a premier service provider of cGMP contract development and sterile manufacturing services for the pharmaceutical, biotech, and medical device industries is pleased to announce it successfully completed a four day cGMP audit of its manufacturing and laboratory facilities.
Medhat S. Gorgy , CEO and Founder of PYRAMID Laboratories commented, "Completing a four day audit without 483s being issued underlines the strength of our quality systems and employee training programs; especially during the time when PYRAMID has continued to expanded our expertise and capabilities for the past 25 years. This is our second GMP audit in the past two years without any observations and that record allows our Clients to trust PYRAMID to provide the highest quality standards and service for their drug product development and manufacturing requirements."
The FDA performed a comprehensive audit; reviewing data from areas such as aseptic manufacturing, lyophilization, analytical development, analytical quality control and stability testing.
PYRAMID Laboratories, Inc., is an independent professional service organization specializing in contract manufacturing, analytical services, product development, formulation, fill/finish/ lyophilization and supporting laboratory services compliant with GLP and cGMP guidelines for all Phases of drug product development and supply; from preclinical toxicology batches to commercial launch and supply. PYRAMID's newest service addition is a 27,000 sq. ft. temperature controlled warehouse & distribution center for parenteral products.
PYRAMID's manufacturing services include formulation, processing, and filling capabilities for both vial and syringe applications.
Learn more about PYRAMID at www.pyramidlabs.com or meet with PYRAMID team members at these conferences: 2013 BIO International Conference, 2013 TIDES Conference and AAPS 2013 Annual Meeting.
1988-2013 - Celebrating 25 Years of Quality, Performance & Integrity
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Source: PYRAMID Laboratories
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