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.
The pharmaceutical industry is one of the most regulated in the world with good reason. Consumers expect products to be safe and effective, and a range of regulations have been developed to maintain manufacturer's compliance.
However, pharma regulations and broader regulations such as Good Manufacturing Practice (GMP) may leave much to interpretation. This white paper explains relevant regulations and how to ensure pharma regulatory compliance along the entire weighing-product lifecycle.
The push for pharma regulatory compliance
National and international standards and regulations such as GMP are becoming increasingly important, if not a prerequisite for conducting business. As such, according to a survey recently conducted by Pharma IQ, nearly 50 percent of participating pharma professionals stated that they spend more than 40 percent of their work time dealing with regulatory issues.
This speaks volumes. In order to maintain pharma regulatory compliance, companies are allocating significant resources to ensure regulations are implemented and processes are validated.
Weighing equipment supports regulatory compliance
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.
How standards affect weighing equipment purchases
The way many regulations are applied can add to a purchaser’s list of questions. What are the relevant pharma regulatory compliance standards 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.
This regulatory white paper also shows how manufacturers can utilize the weighing standard GWP® to ensure pharma regulatory compliance throughout the entire weighing-product lifecycle.