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FEATURED ARTICLES

  • Are Regulators Providing The Right Quality Incentives?
    Are Regulators Providing The Right Quality Incentives?

    If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.

    Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.

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WHITE PAPERS & CASE STUDIES

  • Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types
    Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types

    Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. By Dr. D. Dixon, University of Ulster

  • Biological Contamination Management In Aseptic Environments: Requirements And Expectations

    Bio-contamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources. By James Drinkwater

  • Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry

    As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

  • Pharmaceutical Manufacturing: The Challenge Of Setting Effective Product Specifications

    Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments

  • Quality By Design In Biomanufacturing

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  • Accelerating Generic Approvals: 5 Keys To Being First To Market

    Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.

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PRODUCTS & SERVICES

Analytical and Laboratory Benchtop Instruments

Analytical and Laboratory Benchtop Instruments

In the pharmaceutical sector, where quality and traceability count above all else, the analysis of relevant parameters employing Anton Paar’s analytical and laboratory bench top instruments ensure the consistent high quality of pharmaceutical products. A continuously growing knowledge at the cutting edge of technological developments forms the basis for robust and reliable analytical instruments.

Manufacturing Process Development

Manufacturing Process Development

As early in your project as possible, Patheon's goal will be to solidify a process that sets you up for commercial success. A process that can be readily scaled up from small batch to commercial supply with minimal risk of costly delays and built to deliver repeatable quality.

Clinical Trial Material Manufacturing: Phase II & Phase III

Clinical Trial Material Manufacturing: Phase II & Phase III

Patheon offers expertise in GMP manufacturing of materials to support Phase II and III clinical trials, as well as product registration. 

Pharmaceutical Formulation And Development Services

Pharmaceutical Formulation And Development Services

Kemwell’s Pharmaceutical Development Unit (PDU), in India and Sweden are led by a strong management team with the necessary experience, scientific knowledge, vision and steadfast commitment to meet each customers’ needs.
Data Analysis Consulting

Data Analysis Consulting

Our consulting services help you unlock value within your business and can quickly provide significant returns on your investment.
CMC Workshop: Translating Science Into Successful Regulatory Submissions

CMC Workshop: Translating Science Into Successful Regulatory Submissions

Discuss Challenging Topics Facing the Pharmaceutical and Biopharmaceutical Communities from Development, Implementation, and Regulatory Submissions Perspectives.
Extractables / Leachables Studies

Extractables / Leachables Studies

Extractable and Leachable studies are often straightforward, but they also can be some of the most analytically challenging components of a development program.

<I>Calculations Through Operations&reg;</i>

Calculations Through Operations®

Multisorb Technologies provides leadership, innovation, and solutions utilizing active packaging components to manage moisture, oxygen and/or hydrocarbons in healthcare product packaging to improve product stability.

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