Quality Matters

JANUARY 23, 2023

They include steps championed by USP and others to increase supply chain visibility, support advanced drug manufacturing technologies, and bolster federal health agencies for the benefit of patients and public health. USP looks forward to working with all stakeholders on implementation of these important initiatives in 2023.

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Putting Patients First Blog

APRIL 7, 2025

By ensuring that any inherent limitations or biases are recognized, addressed, and clearly communicated to clinicians and patients, the FDA can help sustain public trust in AI-driven regulatory processes. These variables, tailored to the intended users, can help identify where improvements are needed to support confident decision-making.

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Quality Matters

AUGUST 3, 2023

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients. josh.levin@usp.org Thu, 08/03/2023 - 15:43 Supply Chain

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Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

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Quality Matters

SEPTEMBER 15, 2023

That way…we can do our best to communicate with you about how to best prepare a submission.” While there may be certain regulatory challenges, “there are no regulatory barriers to the adoption of continuous manufacturing, only potentially perceived ones,” asserted presenter Riley Myers, Ph.D.,

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Putting Patients First Blog

APRIL 3, 2023

Members share the Coalition’s vision that “All people have equitable access to and confidence in the accurate, understandable and relevant information necessary to make personally appropriate health decisions.”

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Quality Matters

SEPTEMBER 10, 2024

It follows a series of significant interactions with this country that is a critical part of the global medicines supply chain, including the April 2023 state visit of President Yoon Suk Yeol of the Republic of Korea to the U.S. Our team is diligent about maintaining consistent communication with manufacturers and other key stakeholders.

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Pharmaceutical Technology

MARCH 22, 2023

To keep the EU’s medicine supply intact, Gupta suggests governments should adopt new pricing policies and provide further aid to mitigate the impact of rising operational costs; they should also minimise the exodus of generics manufacturers. Please check your email to download the Report.

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European Pharmaceutical Review

JULY 21, 2023

Europe, too, has faced similar issues with its pharmaceutical supply chain, including critical shortages of antibiotics such as amoxicillin. Recent guidance published by the European Medicines Agency outlines measures that will be taken to increase preparedness for the autumn/winter 2023-2024.

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Pharmaceutical Technology

MARCH 30, 2023

In this instance of contaminated cough syrups, the concern is around an excipient in the product and not the active pharmaceutical ingredient (API). It is therefore essential that all components used in the pharmaceutical manufacturing process and not just the API must be assessed and tested to full monograph specifications.

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GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. via visual inspection or by communication with the responsible personnel). Equipment that is used for processing medicines is one of the top sources of contamination if not cleaned regularly.

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