New York, NY (PressExposure) August 07, 2009 -- Dosing the exact amount of raw materials is crucial for the effectiveness of pharmaceutical preparations. Both underfilling and overfilling are a health risk for consumers: underfilling can render the treatment ineffective while overfilling could endanger the health of the patient. Therefore process tolerances used for pharmaceutical production follow strict rules: underfilling and overfilling must be avoided at all costs!
Fast and efficient quality control with online data For the production and development of liquid and solid pharmaceuticals, the Zambon manufacturing plant in Vicenza has equipped twelve areas with the FreeWeigh.NetÃ‚Â® statistical quality control software solution. These stations are in the main production areas of compression, coating, encapsulation and liquid filling as well as in the quality control lab and in the Research & Development centre.
In each of the twelve stations, samples of tablets, capsules, bottles and/or vials are weighed at regular intervals during each production step. All data is transferred and recorded in the FreeWeigh.NetÃ‚Â® system, which calculates mean values, standard deviations and tolerance ranges. These values are immediately available online at all connected stations and, most importantly, at the six master stations. If a product is discovered to be drifting out of tolerance, immediate actions can be taken by the operator and the production parameters can be corrected timely. This effective process control allows Zambon to minimize product waste, it reduces the risk of lost batches and guarantees consistent product quality.
Electronic batch documentation All relevant batch information and the operator's "signature" are electronically documented. Protected access guarantees that sensitive data can only be seen and/or changed by the authorized people. The functions implemented into FreeWeigh.NetÃ‚Â® ensure full compliance with Food and Drug Administration (FDA)'s 21 Code of Federal Regulations (CFR) Part 11
GMP compliant tracking and tracing A very powerful module of FreeWeigh.NetÃ‚Â® is the audit trail function. Any time a modification is made during production, the module keeps an automatic record of the intervention, along with a timestamp and the operator who made the change. The statistical analysis of this intervention data provides total transparency, through all manufacturing processes, identifying issues and indicating potential areas of optimization.
Efficient system validation METTLER TOLEDO offers proven best practice validation manuals and consulting support for seamless and effective validation of the FreeWeigh.NetÃ‚Â® system in compliance with Good Automated Manufacturing Practice 4 (GAMP) 4 guidelines.