• FDA Inspections: Are Changes On The Horizon?

    A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

  • Life Sciences Deal-Making Gets Creative, Aims At Early Stages Amid COVID-19

    Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets. Check out this article highlighting takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals announced in 2020.

  • Complying With Batch Release: Auditing Electronic Batch Records

    This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. 

  • Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy

    The Centers for Medicare & Medicaid Services (CMS) established a new reimbursement rate for inpatient CAR T-cell delivery in 2021 designed to more closely reflect the true costs of care and address the financial losses experienced by many healthcare institutions. This article delves into details on this and also discusses another significant change for 2021.

  • FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

    The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

  • Establishing An Effective Calibration Program

    Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

  • A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs

    Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations. 

  • Applying QbD To Incorporate Excipients Into Drug Lifecycle Management

    This article is the third in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). In addition to life cycle management, the article delves into continued monitoring, multivariate analysis, continued product verification, and more.


  • Science-Based Technology Selection Process For Bioavailability Enhancement

    Careful selection of the right technology to enhance bioavailability and oral drug absorption is essential in development programs from initial preclinical phases to commercialization. Explore physicochemical and biological obstacles to bioavailability and a process based on a series of inputs including the Target Product Profile, drug properties, extensive past project experiences, technology maps, and absorption modeling.

  • Industry Best Practices For Novel Biotherapeutic Entities

    As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules. However, informatics technologies have not kept pace with these scientific innovations. It’s unlikely that any single life science company, technology vendor or academic group will be able to solve these issues unaided. But together we can establish systems and processes that make working with these new entities more efficient.

  • Viral Clearance: The Basics On How To Conduct Effective Studies

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  • QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1

    Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.

  • Dye Ingress For CCIT: A Poor Bet In A High Stakes Game

    The dye ingress test method continues to be a widely used test method for Container Closure Integrity. This paper explains why the dye ingress test method is not a suitable approach.




This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. To that end, each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique. Additionally, each technique demonstrates the linkage to risk to help demonstrate “a high degree of assurance.”

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