PYRAMID Laboratories, Inc. a clinical and commercial contract aseptic drug product developer and manufacturer is proud to announce it is celebrating 28 years of providing cGMP services to the Pharmaceutical and Biotech industries during July 2016.
PYRAMID's President & CEO, Medhat Gorgy states "I am very proud of the high quality services we have provided the past 28 years and wish to thank our employees and Clients for making it possible. PYRAMID has grown tremendously since our modest beginnings in 1988 to having over 70,000 square feet of GMP facilities with state of the art equipment today."
PYRAMID announces that on Monday, May 16, 2016 through Wednesday, June 1, 2016, the FDA conducted a Pre-Approval and cGMP Inspection at PYRAMID's facilities. PYRAMID Laboratories, Inc. is pleased to announce that the FDA did not issue a Form 483.
PYRAMID was found to be in compliance with cGMP's and has a documentation program that allowed the investigators to easily track, review and assess all aspects of our quality systems. The inspection evaluated various regulatory submissions, operational processes and procedures regarding the utilities, manufacturing process, media fills, batch records, equipment validation, training records, material handling, data review, reporting and records management systems. The investigator also confirmed the compliances of our responses to observations from the previous inspection. All of PYRAMID's systems were found to be compliant and satisfactory with all cGMP requirements.
PYRAMID also announces that it has expanded its portfolio of services with the addition of a new state-of-the-art Warehouse, Storage and Distribution Facility. The new facility includes cGMP labeling, approximately 27,600 cubic feet of monitored and alarmed validated controlled temperature storage, and distribution service capabilities for parenteral drug products. PYRAMID's Warehouse, Storage and Distribution Center is located adjacent to PYRAMID's clinical and commercial manufacturing sites that include aseptic fill/finish for vials and syringes in addition to lyophilization services. PYRAMID also provides full service formulation and process development as well as analytical support for all phases of drug development and manufacturing.