By Louis Garguilo, chief editor, Outsourced Pharma
I suppose it was inevitable. After years of escalating one-upmanship in the CDMO industry, it was only a matter of time before we got the “biggest CDMO on the planet” announcement. But more details were needed. We’ve now got them for you.
This article, originally published in November 2019, has been significantly revised and expanded to address new information issued by the EMA on December 20, 2019. Specifically, the agency modified its original responses to questions 11 and 12 and added questions and answers 13 through 16 to its Q&A on potential nitrosamine contamination.
Has your supplier of primary packaging materials for medicinal products established and implemented — and continued to maintain — an adequate quality management system (QMS)? Generally, most suppliers of packaging materials maintain an ISO 9001 QMS. However, the requirements of ISO 9001 may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to ensure the packaging materials are adequate for their intended use.
The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.
An emerging biopharmaceutical company teams up with a clinical services company to stay on track with timelines and ensure funding milestones are met when faced with unexpected lack of bandwidth and limited global organizational experience.