INSIGHTS ON QUALITY ASSURANCE

• Adapting To Change – API Custom Development And Manufacturing

  A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase II / III trials.

• How A Robust Manufacturing Software Solution Can Reduce The Frequency And Impact Of Deviations

  Read how to leverage manufacturing software with robust digital tools to increase operational visibility and stay on top of deviations so that they don’t turn into corrective/preventive actions (CAPAs), or worse.

• Ferring’s Strategic Approach To Content Management

  With a comprehensive software integration this specialty biopharmaceutical group created a highly connected environment for documentation in quality, R&D, and manufacturing.

• Supplier Quality Agreements 101: What, Who, And Why?

  Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.

• Getting Executive Backing For A Digital QMS

  8/26/2021

  This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

• Formulation Development: Determining Oxygen Sensitivity

  6/3/2020

  Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

• Building Trust – Engineering To Quality & Validation

  12/21/2020

  Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Quality is focused on the identification, mitigation, control of risks to product quality and verification of the process risk control strategy. Historically, the Quality unit has not had sufficient trust in Good Engineering Practices (GEPs) to facilitate their effective use in risk-based C&Q. Why has that trust been missing, and how can it be built?

• A Fill Finish Manufacturing Partner With Resources, Solutions, And Agility

  6/1/2021

  We offer a unique range of formulation and aseptic filling in vials, prefilled syringes, or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

• What's The Difference When It Comes To Managing Quality?

  8/27/2021

  QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.