Featured Pharma Online Editorial

  1. 4 Ways To Prevent Manufacture And Distribution Of Substandard Medications

    If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. 

  2. A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers

    The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.

  3. Overcoming Challenges In Preparing CMC Dossiers — Tips For Success

    Preparing a chemistry, manufacturing, and control (CMC) dossier can be a daunting task.  It is a detail-oriented undertaking, and as the saying goes, the devil is in the details. There are four main questions that need to be addressed for getting it right the first time:

  4. Personalized Medicine – How the Batch Size Will Change Our Lives

    The ability to understand how an individual’s genetic inheritance affects the body’s response to medicine offers tremendous safety and economic advantages. It also impacts the marketing strategy of the biopharmaceutical industry and may drive manufacturers to a wider family of medicines made in smaller batch quantities. This change would cause a shift in manufacturing facility and process design paradigms. Will disposables be the wave of the future or will old paradims prevail?

    By Alfredo Canhoto, Associate Director, Technical Solutions Practice, ProPharma

  5. Stages 2 And 3 QbD Validation Strategies For Nonsterile Solid Dosage Forms

    In my previous communication in February, I provided an overview of stage 1 QbD validation strategies for process design for nonsterile solid dosage forms. In this article, I will continue to highlight strategies for validation prior to release of a commercial product (stages 2 and 3).

  6. Re-Thinking PAT For Cleanability

    Practical and Achievable Perspectives for Changing How You Think About Cleaning Validation. By Jon Yourkin, GE Analytical Instruments

  7. QbD Validation Strategies: The Process Design Phase Part 1

    Process validation comprises three stages that take place over the life cycle of the pharmaceutical drug product. (See Figure 1.)  Stage 1, which will be the focus of this column, is referred to as process design, and encompasses pharmaceutical drug products in early development. Stage 2 is referred to as process qualifications, and includes pharmaceutical drug products at a stage prior to commercialization or prior to submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).  Stage 3 is referred to as continued process verification and includes pharmaceutical drug products that are commercialized and currently marketed products with completed prospective validation. Products that fall in between these categories will need to be assessed on a case-by-case basis and can be placed in the appropriate stage using a "gateway" approach. By Anil Doshi, R.Ph., Ph.D, President, Infinity Pharmaceutical Consulting

  8. Save Time And Money On Turn-Over Packages, Pre-Validation, And Factory Acceptance Testing

    Documentation developed, information collected, and labor expended to create a turn-over package (TOP) for a biopharm modular system represents a significant cost to any project. So much so, that when working with a client, we jokingly say “we sell documentation and you get the system for free.”  To properly validate a system, you have to make the investment in documentation, but you can realize significant labor and cost advantages when developing TOP documentation and pre-validating your modular system via Factory Acceptance Testing in a closed-shop environment. By Mark McGlynn, President, IPEC

  9. 4 Ways Modular Systems Cut Costs

    A primary goal of any customer, when building new or adding equipment to an existing facility, is the ability to source equipment at the lowest and most economical cost possible — while still maintaining a high level of quality.  Modular system suppliers, who provide turn-key systems, have the necessary design, engineering, management, and fabrication capabilities to properly do so.  Internal engineering and construction procedures are developed to expedite the design, fabrication, and management aspects of a project, and are constantly refined to minimize the overall time from project kick-off to start-up and commissioning. Saving time equates to saving money when sourcing and building equipment. A reduction in the overall length of a schedule consequently reduces the cost of the project. By Mark McGlynn, President, IPEC

  10. Investigation Of New Level Technologies In Single Use, Disposable Systems

    This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees