PSC® provided engineer consulting services for the B1 Exit Program Documentation Support Project. The work for this project entailed performing assessments and modifying 3200 Non-GMP documents and/or drawings, 153 documents that needed addressing before shut down, and 14 documents that needed addressing after shut down.
PSC® has been an essential service provider to client throughout the development and implementation of a new cell and gene therapy manufacturing facility. PSC® joined the project during the planning phase and conducted critical design review to ensure facility met cGMP expectations upon completion.
PSC® provided Commissioning, Qualification, and Validation services for the client’s sterile fill/finish manufactuirng and Quality Control laboratory facilities and utilities.
Corporate initiative to upgrade facility compliance level from cosmetics production to meet regulatory expectations of OTC manufacturing. PSC® initiated work with a site audit to perform a gap analysis and identify compliance deficiencies.
We have performed projects ranging from simple projects lasting weeks to multi-year capacity expansions. We have had up to 30 consultants at the Los Angeles site at various times. PSC® has also performed CQV services for another site for almost as long PSC has worked with the Los Angeles, California site.
PSC® served as the key consultants for the entire facility and covered engineering and validation in various functional areas. After the facility reached the operational phase, PSC® continues to provide Engineering Managed Services to Facility Engineering, PMO and automation groups.
