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Commissioning, Qualification and Validation

Meet the team with the "right first time" mindset for CQV.

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CQV for Pharmaceutical Manufacturing Equipment

Expert CQV solutions for seamless pharmaceutical facility startup and validation.

CQV planning, execution and documentation; to ensure regulatory compliance.

For decades, Hyde has been providing robust support for commissioning and start-up of production facilities, process equipment, and control systems.

Our approach is enriched by a profound comprehension of global regulatory standards such as USFDA, EMA, MHRA, Health Canada, and WHO guidelines.

We deliver onsite and offsite services tailored for a diverse range of industries including BioPharma, Vaccines, Oral Solid Dosage, Fill/Finish, Parenteral, Medical Device, Cell & Gene Therapies, and Nutraceutical facilities.

Manufacturing

Facilities and Programs

  • Green Field projects
  • Brown Field projects
  • Decommissioning
  • Strategy development
  • Owners Representation (CQV and PM)

CQV

Delivery and Documentation

  • Commissioning and Validation Master Plans
  • Validation Project Plans (VPPs)
  • Cleaning Validation Master Plans (CVMP)
  • Cleaning Validation strategy build out (Equipment grouping, family approach)
  • Risk-based strategies (ASTM E2500, ICH-Q9 principles)
  • Risk Assessments
  • FAT and SAT support
  • Equipment startup support

  • Commissioning protocol development and execution Protocol development and execution. View more
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Cleaning Validation (CV)
  • Sterilization / Sanitization validation (PQ)
  • Process Validation (PV)

Equipment

Stainless Steel and Single-Use

  • Cell and Gene Therapy
  • BioPharma
  • Pharmaceuticals
  • Plasma Fractionation
  • Vaccines
  • Alternative Meat and Biocommodities
  • Fill / Finish
  • Oligonucleotides
  • Active Pharmaceutical Ingredients
  • Supporting Infrastructure – Utilities, Warehouse, QC, Pilot Plants, Offices

Explore Hyde E+C Services

Expertise in providing tailored solutions from concept to operational systems.

Analytical Laboratory

Ensure methods are validated and your cleaning program is backed by data, with access to the best in the business.
  • Method Validation
  • Recovery Studies
  • Cleaning Optimization
  • MACO Limits Determination

Cleaning Science

Specializing in seamlessly integrating CIP and SIP processes throughout all project phases offering tailored solutions
  • Cleaning Program Development & support
  • Site Engineering Services
  • Engineering Design Services

Engineering

Skilled at taking your project from concept to operation systems.
  • Feasibility studies
  • Conceptual, Basic and Detailed Design
  • Remediation Studies
  • Assessments

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