Master Planning

Developing and implementing Validation Master Plans for single and multi-product manufacturing facilities.

Process Validation

Identifying critical process parameters, developing and executing Process Validation protocols for Pharmaceutical and Biotech manufacturing processes consistent with the FDA January 2011 Guidance for Process Validation, and for Medical Device manufacturing processes per the GHTF 2004 Process Validation Guidance.

Cleaning Validation

Developing and implementing Cleaning Validation Master Plans and Cleaning Programs; also developing, executing and summarizing IQs and OQs for CIP and COP systems. Determining Maximum Allowable Carryover (MACO) calculations; developing and executing Swab Recovery studies to support Cleaning Validation. Also developing and executing PQs for automated and manual cleaning processes and establishing dirty and clean hold expiry times.

Sterilization Validation

Developing, executing and summarizing PQs for moist heat and dry heat component sterilization as well as Sterilize in Place (SIP) cycles for large equipment.

Critical Utility Systems Qualification

Developing, executing and summarizing IQs, OQs and PQs for Direct Impact utility systems such as High Purity water systems (WFI, USPW), Clean In Place systems, clean compressed gases, clean steam, and HVAC/Cleanroom systems.

Design Qualification

Developing and executing concise reviews of User Requirements Specifications against design documentation to confirm that proposed designs will, in fact, meet the User Requirements.

Production Equipment Qualification

Developing, executing and summarizing IQs, OQs and PQs for Direct Impact GMP production equipment such as Bioreactors and Fermenters, Chemical Reactors, Blenders, Tangential Flow Filtration Systems, Chromatography systems, Controlled Temperature Units (CTUs), Vial Fillers and Cappers, Packaging Equipment, Parts Washers, Vial and Stopper Washers, Autoclaves, Depyrogenation Ovens, Lyophilizers and Hot Melt Extrusion equipment.

Combination Products Validation

Developing and implementing Qualification and Validation projects for drug/device Combination Products.

Automation Validation

Developing validation documents such as User Requirements Specifications, Requirements Traceability Matrices and Configuration Specifications to integrate with system IQs and OQs. We also develop, execute and summarize IQs and OQs for automated systems and spreadsheets based upon the GAMP model.

Commissioning

Performing Impact/Risk Assessment of systems and equipment per ISPE and ASTM Guidelines; developing and implementing Commissioning Plans and documents to integrate Commissioning and Startup activities with Validation efforts to minimize repeat testing.

Periodic Validation Review and Re-validation

Developing, executing and summarizing periodic validation review and risk based re-validation programs that have minimum impact on production schedules.

QC Laboratory Equipment

Developing, executing and summarizing IQs, OQs and PQs for Direct Product Impact Laboratory Equipment such as HPLCs, Microplate Readers, and Coulometers.

Compliance

Gap Analysis

Reviewing existing systems against current regulatory expectations, with practical recommendations for addressing identified issues.

Risk Management

Developing and documenting process Risk Assessments consistent with ASTM E2500, ICH Q9 and GHTF Risk Management guidelines, integrating these Risk Assessments with Validation Master Plans.

Quality Systems Design and Implementation

Assisting companies with transitioning from GEP to GMP Compliance in coordination with clinical trials and scaleup to commercial manufacturing, including:

  • Risk Based Validation Planning and Implementation
  • Equipment and Component Level Impact Assessment
  • Validation Master Plans
  • Periodic Validation Review Programs
  • Change Control Systems
  • Deviation Procedures
  • CAPA Systems