The Ultimate Resource on Compliant Weighing in Pharma Production

Regulatory guidance regarding the selection of weighing equipment can be summarized as "must be suitable for the given measurement requirements". Increasingly, a risk assessment of the weighing process is expected to establish the suitable process tolerance and required measurement accuracy.

The accuracy of a scale is defined by establishing its measurement uncertainty. By comparing the relative measurement uncertainty of a scale with your defined weighing tolerance, you can establish the suitability of the scale for this process.
 

• GWP® Recommendation is a free service from METTLER TOLEDO to help you select a scale with an accuracy that meets your process and quality requirements.

Depending on the intended use of the scale and the environment of the weighing process, critical aspects of equipment design include robustness of the construction, durability of the material and ingress protection against liquids and dusts.

Regulations also specifically require that equipment is designed and constructed  with the goal of preventing contamination and cross contamination. The use of corrosion-resistant  materials and construction according to the latest hygienic design guidelines facilitates effective and  efficient cleaning processes and reduces the risk of cross-contamination.

The performance of a weighing instrument will change over time due to environment, wear and tear, or non-apparent damage. To ensure the instrument continues fulfilling the requirements for process tolerance, a monitoring strategy is necessary and is in fact required by GMP.

Standards and regulations are increasingly integrating risk-based thinking into their approach on quality management. A risk-based performance-verification plan will ensure accurate and compliant measurements while optimizing testing frequencies to improve cost efficiency.  

• METTLER TOLEDO's GWP® Verification service assesses the performance of your scale at its operating location. It provides a risk-based testing scheme with clear recommendations for routine test methods, frequencies and weights as well as pass/fail limits.

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. Understanding and controlling the sources and impact of variations on product attributes is the goal of the validation process.

• 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.
• The IPac Installation Package for weighing devices covers the necessary steps of equipment qualification from installation qualification to operational qualification.
• With the Computer System Validation (CSVPac), METTLER TOLEDO offers a comprehensive set of GAMP-compliant validation manuals and product documentation for its formulation and quality management solutions.
• GWP® Verification provides globally recognized assurance for optimal weighing performance with minimal testing efforts. All performance verification procedures are described in a single document. This helps make audits easier.
  

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.

Manual recordkeeping and transcription is a major sources of error and other data integrity violations. Automating all or a part of this data gathering with electronic solutions can help make sure documentation is accurate, traceable and stored safely.
 

• Eliminate manual steps and related transcription errors by connecting the scale directly to a computer. Data communication software such as Data+ or Collect+ allows simple data transfer including metadata such as value and unit, time and date, material ID, net/gross weight and tare.
• Recipe-weighing software or quality-control software such as FormWeigh.Net and FreeWeigh.Net offer strong workflow management as well as data capture and reporting. These solutions provide a traceable audit trail and electronic signatures in compliance with FDA 21 CFR Part 11 and EU Annex 11.