Pharma Regulatory

Pharma Regulatory Compliance: Weighing in Pharma Manufacturing

Pharmaceutical weighing can strongly influence pharma regulatory compliance and final product quality. This white paper explains what companies seeking regulatory compliance in pharma can expect.

Pharma production weighing is usually only one part in a complex process. However, it can strongly influence the quality and integrity of the final product, and it is critical to achieving outcomes such as batch uniformity and consistency in dispensing or formulation processes.

When purchasing 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 pharma regulatory compliance standards as specified in the URS and that it meets process specifications.

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