Pharmaceuticals and Biotechnology
Avoid surprises during audits.
Inadequate or non-specific equipment documentation can lead to FDA Forms 483s, warning letters, psychological stress and extra costs.
GWP® Verification provides a complete set of necessary documentation to pass any external or internal audit. It qualifies the measurement range of your weighing equipment by documenting measurement uncertainty and minimum weight and provides SOPs, test intervals and test limits for lifetime performance verification.
Eliminate out-of-specifications and batch rework.
Inaccurate weight measurements lead to imprecise analytical standards, out-of-specifications (OOS), inconsistent batch quality, reworks, loss of productivity, or in the worst case, product recalls.
GWP® Verification provides proof that your balances and scales are fit for their intended use and meet regulatory requirements (e.g. USP<41>). In case the performance of a scale is found to be inadequate, GWP® Verification recommends immediate measures to recover its accuracy. With GWP®-certified equipment, weighing-related OOS and reworks are a thing of the past.
Save costs with a risk-based CAPA* system. (*Corrective Action / Preventive Action).
Many pharmaceutical companies perform extensive testing of balances believing that more testing yields increased safety and compliance.
GWP® Verification reveals tests that are redundant, too strict, or even erroneous. It benchmarks your actual testing procedures with a risk-based algorithm within GWP®. It clearly pinpoints where testing can be optimized and where costs can be saved without compromising compliance.
For additional safety, activate the GWP® Test Manager functionality (GWP® Excellence) in your balances to assure that all tests are completed on time, correctly and traceably.
Media
- Free Ondemand Webinar on Accurate Weighing in the Pharmaceutical and Chemical Industry
- Webinar: Preventing Costly Out-of-Specification Investigations
- GWP® Verification: The Tablet Factory
- Video: GWP® Verification
- Video: Cost Saving
- Video: GWP® Verification - Reducing Costs
- Video: GWP® Excellence - Automated Routine Testing
Downloads
- Specimen: GWP® Verification for balances
- Specimen: GWP® Verification IND
- Specimen: Summary Report Verification
- Science Based Weighing Standard for Pharmaceutical Industry
- Educational Paper: Reducing Costs
- Educational Paper: Routine Testing
- Educational Paper: Minimum Weight/Safety Factor
- Educational Paper: Quality Assurance
- Datasheet: GWP® Verification