Quality by Design - Regulatory Compliance in Pharmaceuticals

In the pharmaceutical industry, there has always been significant intent to produce drug products with enhanced quality that meets all regulatory standards and requirements. The consistent production of drug products that maintain their desired quality traits has always been a challenge. 

Time and again, regulations have been put in place for pharmaceutical products in order to accomplish the desired therapeutic benefits to the patient community. Yet, in spite of all the massive efforts, news of recalls, rejects, and failures ostensibly due to their quality and manufacturing standards not meeting the criteria that were set. The main factor behind such recurrent lapses to furnish the desired level of quality traits has been attributed to a high degree of variability in drug substances, raw materials, processes, and integrity of packaging materials.

Quality by Design Regulations

In an effort to address these critical issues, much has been done in the industry to transform approaches for developing drug products with robust quality, as well as in an efficient and cost-effective manner. A recent impetus provided by federal agencies for Quality by Design (QbD) has created some vital benefits with respect to implementation in product development. Some of these include the development of quality drug products, enhanced knowledge-sharing, dynamic control strategies, and reduced post-approval changes.

Why Trust MediZap with QbD?

MediZap has invested its time and energy to ensure that the quality and integrity of our clientele’s drug products remain intact post-sterilization. We consistently work with agency and regulatory partners to ensure that all of our designs and methods are innovative and effective.

When working with MediZap, trust that your compliance will always be our interest. We offer support, guidance and provide best practices for each of our customers with respect to document control and compliance. 

Consider us an extension of your quality control and quality assurance teams. You can always feel confident in your efforts with our partnership.

With partners throughout North and South America, we have the benefit of engagement throughout the industry and cascade all of our best practices and insights to our customers to always keep them one step ahead with regulatory guidance. We keep in lockstep with the FDA, DEA, state pharmacy boards, ISO, and much more. We also partner with other industry leaders at conferences led by subject-matter experts.

Additionally, we are firm believers in the ISO protocol related to terminal sterilization - that all products intended to be sterile should be sterilized within their final sealed container. This is something that we do through our Electron Beam Processing, which is recognized by ISO (ISO 13408-1). 

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