DCS PHARMA
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Process Validation (PV)

Process Validation (PV) / Process Performance Qualification (PPQ)

  • Assist in process characterization studies to identify CPPs/CQAs through risk assessments.
  • Assist with process optimisation studies
  • Define bracketing approach for PV
  • Develop the PV policy , Validation Plan (VP) , PV / PPQ protocols and Define Continued Process Performance Verification , write Final Summary Report (FSR)

Sterilisation

  • Autoclaves / Steam Sterilisers (small to large scale)
  • Sterilisation In Place (SIP) of Freeze dryers and vessels
  • Develop and qualify new sterilisation loads in accordance with HTM2010 and EN-285
  • Sterilisation cycle development and optimization
  • Experts in performing Risk Assessments and Gap Analysis on existing cycles and assist in redevelop the cycles to mitigate the risks and comply with current regulations

Thermal Mapping:

  • Specialized in performing mapping studies on all types of Temperature Controlled areas/units and associated environment monitoring systems and software’s.
  • Vapour Phase Hydrogen Peroxide (VPHP) Decontamination
  • Qualification of new transfer hatches and decontamination chambers for transferring materials from ISO 7 to ISO 5.
  • Qualification of filling line isolators Bio-decontamination cycles
  • Qualification of room bio-decontamination
  • Design the loads, Perform Cycle Development (CD) and PQ
  • Define re-qualification frequency, perform re-qualification.
  • Optimise cycle times for existing loads
  • Other Supporting Activities
  • Develop Site Validation Maser Plan , Policies, DI policies, Procedures, WIs, Templates, Workflows , Validation deviations & CAPA’s
  • Experts in creating documentation to support all categories of validation activities Validation Training
  • Gap analysis and remediation projects to address regulatory observations