Do you have an informed response when an auditor asks, "Why are you using this weight to calibrate the scale?" Klosterfrau was ready with an answer because the company uses risk-based verification for their process.
For more than 200 years, German company Klosterfrau Healthcare Group 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, the company runs state of- the-art production lines. Scales and balances, whether in quality control or production, 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 of 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 (GMP) and Good Laboratory Practice (GLP) 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
After METTLER TOLEDO conducted a GWP Verification assessment at Klosterfrau’s Berlin site, Brostmeyer received a risk-based assessment and testing recommendations for each scale and balance.
“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. The risk-based process documentation provided by METTLER TOLEDO left no questions unanswered, and Klosterfrau passed with flying colors.