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Home Expertise Library The Ultimate Resource on Compliant Weighing in Pharma Production

The Ultimate Resource on Compliant Weighing in Pharma Production

Weighing applications in pharma manufacturing can strongly influence final product quality. However, regulations and standards such as GMP and ISO usually leave much to interpretation. This portal provides an overview of relevant standards and regulations for weighing devices and offers a range of knowledge tools such as white papers, guides and webinars that can help you comply with regulations more easily and efficiently.

National and international standards and regulations are becoming increasingly stringent in pharmaceutical manufacturing. Companies are allocating significant resources to ensure regulations are implemented and processes are verified.

However, regulations usually provide broad guidance instead of specific instructions. It is up to the manufacturer to define the criteria to comply with regulations. This often leaves room for interpretation and opens up a range of questions such as:

 

  • Which weighing device fulfills the defined accuracy requirements of the process?
  • How often should the scale be tested to ensure consistent measurement accuracy?
  • How can I ensure the integrity of the weighing data?

Key Regulations and Standards for Weighing Processes

Understanding regulations, weighing processes, weighing technology and metrology is essential to ensure regulatory compliance over the lifetime of a scale. Let's take a look at some of the key regulations as defined by Good Manufacturing Practices (GMP), for example FDA, EMA, WHO, and ISO, that must be met by weighing processes in pharmaceutical production.

 



Regulatory Compliance of Weighing Processes in Pharma Production

Get an overview of the regulatory landscape related to weighing processes and find out which challenges those regulations pose to producers. Understand how weighing systems should be selected, installed and validated and how verification procedures should be established.


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Weighing Equipment Selection

Weighing Equipment Selection

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.
Weighing Equipment Design and Construction

Weighing Equipment Design and Construction

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.

Performance Verification of Weighing Equipment

Performance Verification of Weighing Equipment

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.
  • Learn more about risk-based performance verification
Qualification and Validation of Weighing Processes

Qualification and Validation of Weighing Processes

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.
Ensuring Weighing Data Integrity

Ensuring Weighing Data Integrity

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.