Risk-Based Process Verification
Do you have an informed response when an auditor asks, “Why are you using this weight to calibrate the scale?” Klosterfrau Healthcare Group always has a competent answer regarding its routine balance testing and weighing processes, that allows it to more easily pass audits in the highly regulated pharmaceutical industry.
For more than 200 years, this German-based company has been developing, manufacturing, and selling pharmaceutical products. Its portfolio combines traditional remedies with modern drug therapies and encompasses more than 30 brands and nearly 220 over-the-counter products.
At its Berlin site, Klosterfrau Healthcare Group runs state-of-the-art production lines. Scales and balances are an integral part of the process. Every piece of weighing equipment in use must be regularly calibrated and qualified to ensure regulatory compliance.
The compliance challenge
The challenge for Claudia Brostmeyer, Head Quality Control at the Berlin site, is to ensure that all workplaces – with their variety of processes and responsibilities – calibrate and qualify weighing equipment according to stringent Good Manufacturing Practice and Good Laboratory Practice standards. Running a compliant weighing station is more complex than it may seem. In addition to making sure that a scale or balance is suitable for the application, sound documentation must prove that suitability to auditors. Operators also must be trained according to valid standard operating procedures to ensure periodic equipment testing, calibration, and qualification is done accurately.
When Brostmeyer learned about Good Weighing Practice™ (GWP®) Verification from METTLER TOLEDO, she immediately recognized that this approach would make her life easier. “GWP is a well thought-out and accepted concept that provides a scientific basis for our weighing equipment verification needs,” she says.
Risk-based process assurance
“What I like about the verification document is that it clearly states whether the equipment is suitable for the given process. It also provides recommendations on which tests should be conducted at which intervals with which test weights,” says Brostmeyer. “That makes it easy for me to instruct operators and maintenance personnel on appropriate testing procedures.”
Shortly after METTLER TOLEDO verified the weighing equipment, a production audit put the new process to the test, leaving no questions unanswered.
ISO 9001 and GMP regulations require that weighing equipment be calibrated and verified at defined intervals, but how those tests should be done or how often is not specified.
GWP Verification provides testing recommendations based on your process requirements. It will help you:
- Optimize your routine testing to ensure consistent weighing results.
- Save costs by eliminating unnecessary tests.
- Provide traceable documentation, including testing procedures and frequencies.