VALIDATIONS SERVICES FOR PHARMA, MEDICAL DEVICES,  FOOD AND COSMETICS INDUSTRY

When the equipment meets the product, the focus is now on processes. Our validation scientists and engineers have extensive experience validating all types of processes:  manufacturing processes PPQ (Process Performance Qualification ), cleaning processes (Cleaning Validation), sterilization and decontamination processes (sterilization PQ), and aseptic processes (media fills).

Trained to actively seek process understanding, our validation professionals proactively identify and fully understand the critical process parameters (CPP), critical quality attributes (CQA), and their interrelationships for every process being validated. This fundamental, science-based mindset is equally applied to the validation of analytical methods (Method Validation), packaging process (Packaging Validation) and the areas governed by Good Distribution Practices (GDP) such as warehouse (temperature and humidity mapping) and transportation processes (transport qualification).

Once all processes along the product supply chain have been validated, we support our clients in their quest to maintain The Validated State. Our validation professionals fully understand the expectations for continuous and continued verification set by the international guidelines and regulatory bodies around the world. We establish validation maintenance strategies in accordance with such expectations, and execute re-qualifications as needed.

Our services include:

• Characterization and validation of sterilization and decontamination processes
  • Steam sterilization in autoclaves and stopper processors
  • Qualification of steam-in-place (SIP) systems
  • Qualification of depyrogenation processes
  • Validation of ethylene oxide sterilization process
• Cleaning process characterization and validation
  • Calculation of equipment surface areas
  • Calculation of Cleaning Validation limits and establishment of acceptance criteria
  • Cleaning characterization/validation execution and data analysis
• Method Validation (MV) for analytical, microbiological, and biochemical laboratory test methods
• Process Validation (PPQ) for
  • Drug Product (DP) Manufacturing Unit Operations
    • Oral Solid Dosages (OSD)
    • Parenteral products and aseptic process simulations
    • Lyophilization processes
  • Medical Device Manufacturing
    • Process Engineering support
    • Quality Engineering support
• Inspection and Packaging Processes
  • Support to visual inspection program for parenteral products (e.g. defect library design and creation of test kits, conducting Knapp studies, visual inspector qualification)
  • Serialization project support
  • Packaging Validation
• GDP-related Validations
  • Warehouse mapping
  • Transport Qualification (TQ)
• Validation Maintenance
  • Periodic (time-driven) requalification for critical processes
  • Periodic Review program and execution
  • Validation assessments for change controls

It is important to remember that validation is not a one-off process, it is part of ongoing activity to ensure that quality products are consistently produced.

PMD GROUP

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