GUEST COLUMNISTS

  • ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  • A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility
    A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

    The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

  • FDA FY2018 Drug Inspection Observations And Trends
    FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  • Comparing U.S. & EU Guidances On Combination Product Approval ProcessES
    Comparing U.S. & EU Guidances On Combination Product Approval ProcessES

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.

  • Facilitating Data Integrity Through Risk-Based Confirmation Of Performance
    Facilitating Data Integrity Through Risk-Based Confirmation Of Performance

    We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

  • Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
    Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.

  • An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
    An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  • Danger Ahead: What Biotech Companies Need To Know About Leasing Space
    Danger Ahead: What Biotech Companies Need To Know About Leasing Space

    One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.

More From Our Expert Columnists

PHARMA ONLINE WHITE PAPERS

  • The Definitive Guide To Porosity Characterization

    This paper takes an introductory look at the techniques used to investigate porosity, the data generated and their strengths and limitations for specific materials, covering more complex approaches such as the Reverberi method and the application of non-local density functional theory (NLDFT) to illustrate the necessity for, and potential benefits of, more advanced analysis.

  • How To Optimize Solid-Liquid Mixing

    This paper provides practical information on the efficient use of specialty mixing equipment for the preparation of low, medium and high viscosity solid-liquid mixtures under low and high shear conditions.

  • Enhanced Assurance Of Quality Supply For Single-Use Pre-designed Solutions

    Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.

  • Small Molecule Impurities Represent A Key Challenge When Designing Control Systems For ADC Therapeutic Manufacture

    Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise. Drawing on existing ICH guidelines, a recent publication co-authored by AbbVie suggests a science-based approach that can be applied to the design of an effective control strategy for small molecule impurities in ADC therapeutics.

  • Standardizing Biosample Management - Why Use Collection Kits?

    Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

More Pharma Onine White Papers

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

PO_QualityManagementEbook_300x200

 

Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.

More Content Collections

TRAINING COURSES

CRO Oversight Post ICH GCP E6 (R2) Addendum October 22 - 22, 2019
1pm-2:00pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
More Upcoming Courses