Packaging And Equipment Validation
PSC Biotech provided Validation services for various packaging components such as Cartoner, Wrapper, Case Packing, Conveyor systems with some of the key deliverables as stated below:
Validation (IQ, OQ, And PQ) Of The HVAC System Reconnection
PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS. The PSC® Service Lead manages account (budgets, resources) and provides CSV Subject Matter Expert input.
CGMP Program Compliance And Gap Analysis
his client uses PSC® Biotech’s professional services group to perform cGMP Compliance and Gap Analysis on their operations. The main focus was to assess the quality systems are in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices and to determine if the operation is in a “state of control “.
Auditing – Quality Systems And Records
This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”.
Temperature Controlled Chamber Qualification
PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping.
Cleaning Validation Risk Assessment
This client utilizes PSC® Biotech’s professional services group to perform Gap Assessment on Cleaning Validation on their manufacturing equipment to maintain regulatory compliance and expectations. PSC® validation engineers evaluated the appropriate records, performed a gap analysis, and identified areas for continuous improvement.
