Regulatory Compliance Featured Articles

  1. Calibration, A Critical Success Factor For Mapping In Pharma Manufacturing

    A decision about making, or not making, a pre or post calibration check can be the difference between a successful study or a time consuming failure.

  2. Mapping Strategy Fundamentals For Regulatory Compliance

    In order to comply with regulatory mandates in the manufacture of pharmaceuticals, you need a mapping strategy several reasons. 

  3. Making Sense Of Sensor Numbers And Placement

    There are many factors that are in play for the number of sensors required. It would be nice if there was a simple formula such as one sensor per square foot or per square meter.

  4. Monitoring Mistakes: Avoid The Most Common Mapping Issues

    In spite of the headline, it is difficult to pin point the one single most common mistake. This articles focuses on what not to do, or what to avoid, during the mapping process.

  5. What Does "Child Resistant Packaging" Mean In Pharma?

    Child resistant packaging intergrates the use of safety mechanisms and physical barriers to reduce the risk of poisining in children via the ingestion of potentially hazardous medicines.

  6. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.

  7. Incorporate Data Integrity Into Your Pharma Quality Management System

    A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable. 

  8. Managing GxP Environmental Systems To Ensure Data Integrity

    In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.

  9. Perfect Potent API Processing: Handling Hazardous Drug Actives Effectively

    The journey from discovery to pharmacy is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage.

  10. A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017

    The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.