Your outsourcing may come in the form of manufacturing of a sterile injectable, tablets, or topical dosage form or it may be GMP product release and stability testing. The product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The suppliers you choose are of paramount importance to your company’s success.
If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. One step that can get neglected, or appear to be of lesser importance than the remainder of these, is the completion of packaging and labeling for the launch product.
In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.
Cell-based potency assays don’t travel well. Here’s how to make their trip more pleasant from a non-GMP lab to a GMP environment.
To fully realize the potential of bioelectronic medicine, medical device developers will need to find ways to move beyond "set and forget" biostimulation devices to closed-loop systems that can provide more responsive and personalized treatments.
This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI).
On June 12, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted.
This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.
Both cell-based therapies and non cell-based therapies are developed as immunotherapies and therefore share some similar challenges in development.
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