Pyramid Laboratories, Inc. a contract aseptic drug product developer and manufacturer, has expanded with the addition of warehouse, storage, and distribution facility in Costa Mesa, California.

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. The center is located adjacent to the company’s clinical and commercial manufacturing sites in Costa Mesa that include aseptic fill/finish for vials and syringes in addition to lyophilization services.

The company also reports that it successfully completed a pre-approval and cGMP inspection by the US Food and Drug Administration at its facilities. The inspection took place May 16, 2016 through June 1, 2016. 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 the company’s responses to observations from the previous inspection. All of systems were found to be compliant and satisfactory with all cGMP requirements, noted the company. 

Source: Pyramid Laboratories