White Paper

Regulatory Compliance: Weighing In Pharma Manufacturing

By Doug Dodridge

Regulatory compliance iStock-1256156511

The pharmaceutical industry is one of the most regulated in the world. National and international standards and regulations, such as Good Manufacturing Practice (GMP), are becoming increasingly important, if not a prerequisite for conducting business. Companies are allocating significant resources to ensure regulations are implemented and processes are validated.

However, regulations usually only provide broad guidance (e.g. measuring devices must be calibrated) and leave it to the manufacturer to define the criteria to ensure regulatory compliance (e.g. how often to calibrate). This intentional vagueness provides the necessary flexibility to the manufacturer to adapt quality control procedures to the specific process requirements, but it also contributes to uncertainty about which practices are sufficient. Thus, an in-depth understanding of the regulations, processes, technology and metrology is essential to ensure compliance.

Weighing applications in pharma production are usually only one part in a complex process. However, they can strongly influence the quality and integrity of the final product. For example, weighing is critical to achieving batch uniformity and consistency in dispensing or formulation processes. When planning to purchase new weighing solutions, companies usually define the requirements according to the relevant regulations and the company's processes in a User Requirement Specification (URS) document. Once the weighing solution has been selected and installed, equipment qualification and, if required, process validation must be conducted to prove that the installed solution fulfills the requirements as specified in the URS and that it is compliant with regulations and process specifications.

But what are the relevant regulations with regard to weighing applications? How should weighing systems be selected, installed and validated? How should maintenance and service processes be established? The aim of this white paper is to provide an overview of the regulatory landscape related to weighing processes in pharmaceutical production and explain the challenges those regulations pose to manufacturers. Furthermore, the white paper shows how manufacturers can utilize the weighing standard GWP® to ensure regulatory compliance throughout the entire weighing product lifecycle.

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