Description.
Given the complexities of the Critical Services Redevelopment Project including the magnitude, the most complex functions of the hospital, as well as the sharing of a common facility with adults and pediatrics, this project was stalled for over 20 years. Our project manager at PharmEng reviewed the entire process and established an organization structure and[…..] […]
Keata Pharma is a state-of-the-art pharmaceutical manufacturing facility for solid and liquid dosage forms. PharmEng provided design expertise by implementing a cost-effective GMP system to ensure that this facility will meet regulatory requirements internationally. This facility encompasses GMP compliant QC laboratories, manufacturing and packaging suites for solid and liquid dosage forms. The plant received its[…..] […]
This client is a primary wholesaler of pharmaceutical products. A new facility was added to extend their services to the repackaging of solid-dosages. PharmEng provided qualification services and cGMP expertise to ensure the new facility was cGMP compliant within budget and on schedule. Responsibilities: cGMP Gap Analysis cGMP Review of Processes FATs & SATs Commissioning[…..] […]
PharmEng was engaged as an international compliance consultant to help prepare for the Client’s first-ever EU submissions. Responsibilities: QbD / technology transfer consultancy Cleaning validation advisory Process validation advisory Equipment validation review Process scale-up and site transfer advisory, technology transfer plan Process development protocols and DoE review & advisory Cleaning validation and process validation drafting,[…..] […]
