Articles in this Issue

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  Quality Assurance: COVID-19’s Impact on FDA Inspections and Manufacturer Risk

  October 16, 2020
  COVID-19 has impacted virtually every industry, and drug manufacturing is no exception. While changes in the demand for certain drug products is reshaping the industry and capturing headlines, another issue permeating the conversation is how the pandemic has disrupted the Food and Drug ... read more
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  Excipient Quality: Beyond the Pharmacopeia Monograph

  October 16, 2020
  Excipients are anomalies of pharmaceutical science. They typically do not treat a disease or improve the patient’s quality of life, but without them, many of the therapeutic advances of the last 100 years or so would not have happened. Excipients, along with the product manufacturing process, help ... read more
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  Quality by Design: Using a Development and Submission Stage Gate System to Help Improve Drug...

  October 16, 2020
  Depending on who you ask, the emergence of Quality by Design (QbD) principles in the pharmaceutical regulatory landscape heralds either unwelcome new challenges for drug developers or a golden opportunity to improve quality and drive better business outcomes. Neither opinion is objectively wrong. read more
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  Excipients: Using Natural Alternative Excipients for Tableting and Capsule Filling

  October 16, 2020
  A large number of dietary supplements are available in solid oral dosage forms. Vitamin and mineral supplements can be easily pressed into tablets by wet granulation or direct compression, but such tablet formulations require good binders. Commonly used binders in tablet formulations include ... read more
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  Validation and Regulatory Compliance: Validation, Verification, and Monitoring of Tablet and...

  October 16, 2020
  Validation and Regulatory Compliance: Validation, Verification, and Monitoring of Tablet and Capsule Blister Pack Inspection Systems read more
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  Regulatory Compliance: Adapting to Change is the Name of the Game

  October 16, 2020
  This year has brought a number of changes to the food and supplement industries, with perhaps none greater than the changes to the regulations governing the labeling of dietary supplements, food, and beverages. While changes to the look and feel of the Nutrition Facts labels for food and beverages, ... read more
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  Eye on Excipients: Orodispersible Mini Tablets as an Alternative Dosage Form for Pediatric...

  October 16, 2020
  Oral drug delivery by tablet is the most convenient route of administration for a medicine. However, some patient groups have difficulty swallowing (dysphagia) or have format, taste, and texture preferences that require alternative administration methods. For this reason, formulators are striving to... read more
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  Reduce Powder Processing Risks when Outsourcing Manufacturing

  October 16, 2020
  When outsourcing manufacturing for an oral solid dosage product, brand owners generally minimize risk by ensuring that the contract manufacturing organization’s (CMO’s) unit operations have the desired capability and have been tested with the target formulation and that the area has sufficient ... read more