NEWS & EVENTS
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
1988-2018 – Celebrating 30 Years of Quality, Performance & Integrity
- CPhI North America 2019 (Booth 1642), April 30-May 2, McCormick Place, Chicago, IL
- TIDES Conference 2019 (Booth 402), May 20-23, 2019, Manchester Grand Hyatt, San Diego, CA
- Bio International Convention 2019 (Booth 4327), June 3-6, 2019, Philadelphia Convention Center, Philadelphia, PA
Drug Development EXECUTIVE INTERVIEW – PYRAMID: Prescription for Building Success Through Partnerships. Quality. Integrity. Performance. These words may best describe the foundation upon which PYRAMID was built when it was founded in 1988 as an analytical services and method development company. This foundation has grown ever stronger throughout the past 28 years as it has transitioned from a 600-sq-ft laboratory into a 70,000-sq-ft commercial manufacturing facility with the expertise and flexibility to provide analytical, development, and small- and large-scale aseptic manufacturing and filling services to small start-up biotechs, big pharmas, and everyone in between. Drug Development & Delivery recently spoke with Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., to discuss his success in building futures with his clients and more importantly, the lessons he’s learned along the way. more>>
Sep. 2, 2016
PYRAMID Laboratories, Inc., – Complete Another Successful FDA Inspection (PR Newswire). PYRAMID’s manufacturing services include formulation, processing, and filling capabilities for both vial and syringe applications. more>>
June 16, 2016
PYRAMID Laboratories, Inc., Complete Successful FDA Inspection (PR Newswire). 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. more>>
June 8, 2016
PYRAMID Laboratories, Inc. Celebrates 28th Anniversary and Expands Capabilities (PR Newswire). Aseptic Drug Product Manufacturing and GMP Controlled Temperature Storage & Distribution. more>>
May 15, 2013
Oscar R. Rebolledo, Ph.D.; Technical Sales-Business Development at DAISO Fine Chem USA,was the winner in our drawing for the iPad mini at the TIDES conference held last week in Boston. Oscar is pictured below with PYRAMID CEO Medhat Gorgy. more>>
April 23, 2013
Medhat Gorgy, President and CEO PYRAMID LABORATORIES @BIO International 2013 (DAY 2) watch>>
April 22, 2013
Medhat Gorgy, President and CEO PYRAMID LABORATORIES @BIO International 2013 (DAY 1) watch>>
April 2, 2013
PYRAMID Laboratories, Inc. Completes Successful FDA Audit. (PR Newswire) Second Consecutive FDA Audit Without Observations. more>>
November 1, 2011
Pharmaceutical Outsourcing – An Interview with Medhat Gorgy President & CEO PYRAMID Laboratories, Inc. more>>
May 6, 2009
U.S. Small Business Administration Names Medhat Gorgy Small Business Person Of The Year
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc.(PLI) has been named the Small Business Person of the Year 2009 by the U.S. Small Business Administration, Santa Ana District Office. The district serves the counties of Orange, Riverside and San Bernardino. more>>