PYRAMID Laboratories, Inc. a clinical and commercial contract aseptic drug developer and manufacturer, has successfully completed an FDA Pre-Approval and cGMP Inspection at it facilities. PYRAMID was found to be in compliance with cGMP and the FDA did not issue a Form 483.
 
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 compliance of the company’s responses to observations from the previous inspection. All of PYRAMID’s systems were found to be compliant and satisfactory with all cGMP requirements.
 
Additionally, the company has expanded its services with the addition of a new warehouse, storage and distribution facility that includes cGMP labeling, approximately 27,600 cubic feet of monitored and alarmed validated controlled temperature storage, and distribution service capabilities for parenteral drug products. The new 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’s president and chief executive officer, Medhat Gorgy said, “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.”

Visit Pyramid Labs at Table 142