PSC® performed commissioning of utilities, EMS, Electrical and HVAC for this clients facility. The team worked on the environmental monitoring system (EMS): Monitoring for each individual room, at the formulation standpoint. Each room was required to meet a certain criterion for how much pressure was in there.
PSC® supported a small, start-up biopharmaceutical company with their Investigational New Drug (IND) application. With commentary from the FDA and a short time-line, PSC provided updates and modifications to the IND Phase I Clinical Trial Submission to ensure FDA approval.
PSC® Provided Supplier Quality Audit services for food and nutritional supplement manufacturing facilities auditing to 21 CFR 110, 21 CFR 111 and customer quality standards.
PSC® performed cGMP Program Compliance and Gap Analysis and trained their staff on current good manufacturing practices. The audit also covered US FDA and European Current Good Manufacturing Practices.
PSC® performed mock FDA prior approval audit. Performed inspection of cGMP Manufacturing facility and the associated cGMP Quality Systems. PSC® developed audit response plans, corrective action and regulatory compliance plan, and trained staff. PSC®, developed cGMP training content for facilities.
PSC® has been providing engineering and validation services at the San Dimas facility since 2014. When the La Verne facility startup projects began, PSC® has been providing validation support to keep the facility operational. PSC® covers all aspects of facilities, utilities and process equipment qualification and validation across the entire facility.
