SERVICES

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Good Manufacturing Practices (GMP)

Our experts can help with all your GMP needs to comply with CFR 21 Parts 11, 210 & 211 and ICH Q7: 
  • GMP training
  • Standard Operating Procedures
  • Electronic Records and Electronic Signatures
  • Cleaning
  • Sterilization
  • Cold chain logistics
  • Master planning
  • Production and filling lines
  • Bulk pharmaceutical equipment
  • Packaging and labeling
  • Batch Records and reporting

Good Quality Practices (GQP)

Let us help you with your quality challenges.  Whether complying with quality requirements in 21CFR Part 210, 211, 600, 601, 610, or 820, we can build a measured, but robust quality system that's right for your organization size and stage.
  • Quality auditing
  • Quality system workflows
  • SOPs
  • Deviation and CAPA programs
  • Change Control
  • Document controls
  • Inspection of raw materials
  • Batch records
  • Equipment use logs
  • Complaint handling
  • Personnel training
  • Supplier auditing

Good Laboratory Practices (GLP)

A GMP facility must have a GLP compliant testing laboratory.  Let us guide you to a state of laboratory control.  
  • Sample plans, testing, release and rejection
  • Specification writing
  • Laboratory SOPs & workflows
  • Out-of-Specification (OOS) handling
  • Laboratory instruments qualification
  • Validation of analytical procedures
  • Expiration and stability studies

Good Engineering Practices (GEP)

We utilize proven, best practice engineering methods that are cost-effective and tailored to each client.  Our methodology allows the leveraging of the GEP activity for verification work as outlined in ASTM e2500.  Our GEP practice includes:
  • Project engineering
  • Project purchasing
  • Design review
  • Standards and procedures
  • Engineering change management
  • Maintenance manuals and record keeping
  • Equipment and facility commissioning and decommissioning

Validation & Qualification

We are a turn-key validation, commissioning and qualification service provider.  We have successfully helped numerous clients with:
  • Computerized Systems Validation (CSV)
  • Commissioning, IQ, OQ and PQ of equipment, instruments and facilities
  • Material Qualification - leachables and extractables
  • Validation Master Plans
  • Cleaning Validation (SIP, CIP, COP)
  • Process validation
  • URS, DS, FRS writing
  • Controlled temperature mapping
  • Sterilization & Depyrogenation
  • Lyophilization
  • Risk Assessments
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