• Important cGMP Considerations For Implementing Electronic Batch Records

    Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. 

  • Incorporating Excipients Into QbD Studies For Drug Development — An Introduction

    This article is the first 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. Topics covered include measuring the impact of excipient variability on finished product quality and more!

  • FDA Steps Up Support For Advanced Manufacturing Technologies

    In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.

  • FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers

    Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

  • Developing Future Delivery Models For ATMPs: Practical Considerations

    With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.

  • 7 Rules For Properly Interpreting Control Charts

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

  • 9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants

    Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.

  • Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?

    The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.


  • Labtainer Pro BPC Extractables Profile

    With the introduction of the Thermo Scientific Labtainer Pro BPC, Thermo Fisher Scientific offers a compilation of the standard BPC assemblies for use in conjunction with other bioprocessing products.

  • Contamination Control Strategies For Pharmaceutical Manufacturing Environments

    Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.

  • Cell Growth Performance In Single-Use Bags

    Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are towards higher cell densities and protein titers.

  • User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe

    Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

  • Identifying Enhanced Needle Solutions & Integrated System Solutions To Serve The Chronic Disease Market

    In addition to wider uptake of home care, an increase in the number of biologics being manufactured, many by the same company, is driving ongoing innovation in drug delivery systems. Identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.

  • Preventing Sticking And Picking Through Tablet Design

    Sticking or picking issues are often not detected. Prevent unanticipated problems during scale-up and full-scale production by considering tablet compression issues before tablet designs are finalized.




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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