Because weighing applications are an essential element of the production process, they are often the focus of auditors.
The white paper, Validation of Weighing Processes, explains what should be considered for the validation of weighing processes and how METTLER TOLEDO can support you in ensuring worry-free audits, including:
- What to consider during process design
- How to carry out efficient weighing processes validation
- How to ensure continuous weighing process verification
What is Process Validation?
Process validation is a legally enforceable requirement in the U.S. and the European Union, as well as many other countries where drugs are produced. It is defined as a series of activities that establish scientific evidence that a process is capable of consistently delivering high-quality product.
What does GMP say about weighing?
- "Weighing and measuring devices should be of suitable accuracy for the intended use." (ICH Q7A GMP, Sec. 8.1)
- "Balances and measuring equipment of an appropriate range and precision should be available for production and control operations." (Eudralex Volume 4, Sec. 3.40
What is a Safe Weighing Range?
The safe weighing range of a specific instrument is the range in which the user fulfills both the weighing tolerance requirement and adheres to the required safety factor.
What is GWP®?
Good Weighing Practice™ (GWP) is based on scientific methodology to help you select the scale that meets your accuracy needs. The resulting documentation provides evidence that you have selected the device that meets your exact process requirements.