Client produces anticancer medicine and immunosuppressive drugs. PharmEng provided international GMP and Qualification expertise to qualify equipment and systems in CKD-OTTO’s greenfield facility. Responsibilities: Risk Assessment SOP advisory & review. Commissioning advisory & review Facility & Utilities Qualification Process Equipment Qualification Laboratory Qualification Computerized System Validation Media Fill Assistance BPOM audit assistance Exterior View Aseptic[…..] […]
Read More…
PharmEng provided technology transfer and start up services, qualification services, and cGMP expertise to help the client conduct three international technology transfers and start-up projects. PharmEng also completed validation activities that involved transfer of processes, equipment, and facilities from the parent site to a recipient site, while meeting the client’s quality requirements on time and[…..] […]
Read More…
PharmEng provided constructive review of the conceptual plans for cGMP compliance. The client retained PharmEng Technology to apply knowledge and practical experiences with the World Health Organziation GMPs , and North Amercian US – FDA and Canada – Health Canada cGMPs to the planned facility in Iran. PharmEng provided constructive review of the conceptual plans[…..] […]
Read More…
Cosmaceutical Research’s new facility was designed to manufacture GMP semi-solids and liquids. PharmEng provided equipment planning and GMP compliance expertise to ensure that this plant will meet GMP requirements. Cosmaceutical Research Lab moved into the new state-of-the-art facility in May 2007 with a significant increase in capacity and quality control measures. Responsibilities: Functional/Space Programming Functional[…..] […]
Read More…
