INSIGHTS ON REGULATORY COMPLIANCE

• Control Strategy: What, When, Where And Why For Drug-Device Combination Products

  Building a control strategy starts with understanding the product and process and comprises understanding the connectivity among materials of composition, components, constituent parts, final drug-device combination product, and critical process parameters.

• How To Understand ASTM E2500

  ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.

• Upstream Considerations For Biosimilar Development

  Understanding upstream challenges during biosimilar development and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.

• Ditch The Checklist: Why Automation Is The Key To Content Compliance

  Checklists work for things like house maintenance; you identify and fix the things that don’t meet building codes, and then you feel safe, and the building inspector is happy. Content, however, doesn’t operate like that. Some content is essentially stateless; because of collaboration or continuously changing data, content assets change. Identifying adherence to compliance controls, therefore, means it has to be evaluated continuously. Automated, continuous monitoring is imperative for companies that depend on their critical content to make business decisions and conduct operations.

• Annex 11: The EU’s New Expectations For Regulated Computerized Systems

  8/27/2021

  The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.

• Writing and Enforcing GxP SOPs For Compliance

  10/1/2021

  For fiscal year 2020, the most common FDA inspectional observations for biologics, devices, and drugs involved SOPs. To avoid a warning letter from the FDA, life sciences companies need a methodical approach to their SOPs.

• CDMO Collaboration: Foundation For Sterile Injectable Product Success

  6/1/2021

  Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.

• 21 CFR Part 11 — Are You Ready For An FDA Inspection?

  8/27/2021

  Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.

• Aseptic Vial Filling

  6/18/2021

  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.