Case Studies: Accurate and Traceable Weighing

Solutions for Ensuring Product Quality and Smooth Audits

Pharmaceutical manufacturers face pressure internally to ensure the highest product quality while maximizing the use of their material and processes. They also face external pressures from regulatory bodies to meet strict compliance standards.

Our Case Study Collection highlights 3 success stories of pharmaceutical manufacturers who have utilized our GWP program to ensure product quality and regulatory compliance. Successes include:

Proven process control with quality-by-design
Smooth audits with risk-based process verification
Process evolution with proper planning

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GWP^® Verification for Consistent Quality

GWP^®, or Good Weighing Practice™ is a program designed by METTLER TOLEDO to help operations select, verify and upkeep the right equipment for their processes. This program is especially useful to pharmaceutical manufacturers who undergo intense auditing on a regular basis.

GWP^® Verification can help ensure:

You achieve consistent quality
You are saving costs by managing equipment efficiently
You maintain complete data and audit-proof documentation

For full details on GWP^® Verification, click here.

Understanding regulations, weighing processes, weighing technology and metrology will help ensure regulatory compliance for audits from authorities. Having good and complete documentation defined by Good Manufacturing Practices (GMP), for example FDA, EMA, WHO, and ISO, will help prove to auditors that your process is in control.

Risk-based thinking ensures risk is considered from the beginning and throughout the process, and makes preventive action part of strategic and operational planning. Risk-based process verification assesses the weighing process risk according to the weighing accuracy required and the business impact of inaccurate measurements.

Smoother audits can be ensured by identifying critical process attributes and parameters in process design, evaluating process design, and ensuring processes remain under control with adequate routine testing. For more information, check out our Validation Support White Paper at www.mt.com/ind-validation-support

Understanding and complying with the qualification and validation steps of weighing processes can help ensure a smooth transition during times of change. Weighing processes are critical to high-quality products and the performance of the scale is a critical process parameter. Good Weighing Practice™ (GWP^®) provides outstanding support in weighing process validation and equipment qualification.

Ensuring you comply with data integrity principles is an essential step to comply with GMP regulations. The integrity and reliability of data generated across the entire pharma production chain is a fundamental regulatory requirement around the world. Weighing processes – particularly if they are quality-critical – are subject to these requirements and must apply to Good Documentation Practice guidelines.