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FEATURED ARTICLES

  • Analytical QbD at Teva: Knowledge Is Power Only When You Share It
    Analytical QbD at Teva: Knowledge Is Power Only When You Share It

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

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WHITE PAPERS & CASE STUDIES

  • Can Manufacturing Challenge QC On Viscosity Measurement?
    Can Manufacturing Challenge QC On Viscosity Measurement?

    The current batch of skin cream lotion seems ok to the eye. It has the same feel and appearance as all the other batches produced earlier in the week.

  • A QbD Approach To Freeze Drying Of Cytotoxic Compounds
    A QbD Approach To Freeze Drying Of Cytotoxic Compounds

    Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward

  • Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
    Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods

    Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software

  • Raising Expectations Of Excipients

    An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails. By Fred Monsuur, Julia Poncher W. R. Grace & Co

  • 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

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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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