LeanWays

Be sure you put your feet in the right place, then stand firm.”
– Abraham Lincoln

LeanWays

Be sure you put your feet in the right place, then stand firm.”
– Abraham Lincoln

Process and Cleaning Validation

Process validation is about making sure and proving that your process performs as it should, i.e. in a robust and consistent way, delivering quality product.

Cleaning Validation is about ensuring and proving that your cleaning methods perform as they should, i.e. in a robust and consistent way, delivering quality product with acceptable (low & predetermined) levels of carry-over or impurities in it.

For which industries can it be useful?

  • For highly regulated industries such as in the pharmaceutical sector, ranging from large pharma to CMOs and biotech start-ups.
  • For food and cosmetic industries.

    Process Validation (PV)

    We help your business:

    • Validate your processes, whether concerning
      solid dosage forms, soft capsules and creams,
      vaccines or plasma-based derivatives
      manufacturing.

    By:

    • Ensuring that your Process Design, Qualification, and Continued Process 
      Verification comply with current Good Manufacturing Practices (cGMP).
    • Supporting you during compliance audits and inspections, both FDA and EMEA Health Authorities.
    • Providing training to your team.

    Cleaning Validation (CV)

     

    We help your business:

    • Evaluate and validate your cleaning processes, both Manual operations (our area of expertise) and CIP Cleaning in Place.
    • Ensure that your Cleaning Design, Qualification, and Validation Maintenance comply with cGMPs.

    By:

    • Installing and implementing an ICH Q9 Quality Risk
      Management approach for your site.
    • Defining a robust strategy and harmonizing your CV practices.
    • Assisting you in the reduction of your site microbial
      contamination.
    • Providing training to your team.