Services

Validation/Regulatory services:

Qualification

  • Responsible for the qualification / validation studies required to support the introduction of new manufacturing, filling and packaging processes as well as the monitoring / re-qualification of existing processes and challenging integrated lines.
  • Generate list of prerequisites required prior to initiating process qualification / validation activities.
  • Generate protocols, technical memos, feasibility / development studies, sampling plans, acceptance criteria, and final reports.
  • Support the generation of defect inspection criteria and AQL based sampling plans.
  • Develop qualification / validation rationales for requirement of number of challenge runs, bracketing, matrix, and critical process / product parameters.
  • Communicate status of prerequisites, open items, deviations, execution activities and project timelines.
  • Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
  • Generate, review and approve validation procedures.
  • Generate final reports, compile historical data packages, preform statistical evaluation, generate discussion of results and scientific based conclusions, and route documents for approval.
  • Generate and maintain a site process qualification / validation program plan.
  • Review and approve interventions and assess product impact / potential product risk as the result of atypical interventions.

Validation

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  • Execute validation (utility, equipment, cleaning, process) which includes protocol preparation, scheduling, protocol execution, and final report preparation.
  • Conduct and/or participate in deviation investigations to identify root causes and define corrective / preventative actions (CAPAs).
  • Mentor and develop new hires regarding validation techniques and procedures to ensure compliance with defined procedures.
  • Represent Technical Operations in cross-functional teams assembled to install, validate, troubleshoot and maintain equipment and processes.
  • Participate and support Lean projects and process improvements.

Regulatory

  • Designs and drives Quality processes to assure GxP compliance for:
  • Disposition of drug substances and investigational medicinal products
  • Clinical Study quality audit planning, execution and resolution of issues
  • Participates in the planning and content development and review of global regulatory submissions.
  • Serves as the Quality representative on project teams and manage relationships with counterparts within Service Provider organizations.
  • Designs and oversees the execution of cGXP and SOP training programs.
  • Develops quality management budget and monitor expenditures.
  • Provides strategic direction and oversight in the development of the company’s Pharmaceutical Quality Systems.
  • Identifies cGXP and other key compliance requirements, and provide leadership in promoting awareness and understanding of global regulatory compliance expectations.
  • Develops and maintain centralized system for GXP document and record control, archival, protection and access.
  • Edits and approves standard operating procedures (SOPs) proposed from functional areas. Assure harmony across all SOPs, and shared responsibilities at functional interfaces.
  • Assures proper Service Provider qualification (and disqualification).
  • Leads the Internal Audit Program process, including assessment of internal and external (or outsourced) cGXP operations.
  • Provides leadership across cross-functional areas, and ensure that drug development activities are conducted and data are generated, documented, reported and maintained in compliance with cGXP requirements.
  • Makes recommendations for improvement of product quality and quality system efficiency.

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Engineering Services (Laboratory and manufacturing Equipment):

Metrology

  • Calibration Consultancy
  • Development of Calibration Procedures
  • Calibration Data Entry
  • Completion of Calibration Forms

Preventive Maintenance

  • Development of PM Procedures
  • PM Documentation Data Entry
  • Completion of PM Forms

Commissioning

  • Commissioning Plan
  • Commissioning Protocols

Project Management

  • Sub-Contractors Management
  • Schedule Development and Maintenance
  • Cost Control and Inventory Management

 

Other Services:

Test Equipment Rental

  • Data Loggers
  • Thermometers
  • Calipers
  • Volt meters
  • Timers

Temperature Mapping Services:

  • Protocol development
  • Trial execution
  • Data analysis
  • Reporting

Temperature Mapping Equipment List:

  • Freezers, Ultra Low Freezers, and Control Rate Freezers
  • Refrigerators
  • Incubators
  • Cold Rooms
  • Autoclaves
  • Ovens
  • Stability Rooms
  • Stability Chambers
  • Warehouse Storage Facilities

 

Laboratory and Manufacturing Equipment Maintenace/Repairs/Troubleshooting

 Laboratory and Manufacturing Equipment List:

  • HPLC Systems (with UV, PDA, and IC and RI Detectors)
  • GC Computerized Systems(all types)
  • UV/Infrared Spectrophotometers
  • Multiple Dissolution Stations with Auto Sampler (USP Apparatus I, II, and III)
  • Various pH meters, hardness testers, friabilitors, and torque testers (Tablet Micrometers)
  • Disintegration baths
  • Tap density testers
  • Fluid bed processors
  • High Shear Granulators/Blenders(all types)
  • Planetary Mixers
  • Tablet press/tooling(s)
  • Various semiautomatic compression and encapsulation machines
  • Various granulation and compounding equipment
  • Pharmaceutical Metal Detectors
  • Induction Cap Sealing Machines
  • Manufacturing and Laboratory Ovens
  • And many more!