Pharmaceutical Packaging Editorial
-
Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity
8/18/2021
The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.
-
EMA Publishes Guideline On Quality Documentation For Medicinal Products
8/2/2021
This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.
-
Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation
7/21/2021
A robust human factors process is critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.
-
Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
7/5/2021
In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.
-
A Better Approach To Aseptic Process Simulation For Lyophilized Products
5/9/2021
Proposed 2020 revisions to EU Annex 11 with respect to aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on best practices for process simulation of the lyophilization unit operation. This article serves to address these expectations and present a risk-based, holistic best practice approach.
-
How To Use DMF Content To Support Your Application To The FDA
4/30/2021
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?
-
Challenges With Fill Finish Services Not Finished
2/11/2019
Ours is a responsive Editorial Advisory Board, but no question posed to them elicited the range and rate of response as this one: “What are the biggest challenges you face with outsourcing fill finish services – what keeps you up at night?” Chances are Outsourced Pharma readers are also experiencing the challenges board members told us about.
-
2 Reasons Your CDMOs Are Consolidating: Money & Muscle
11/7/2018
Private equity is providing the M&A fuel for CDMOs, fill-and-finish specialists, and clinical and commercial packaging partners. Big Pharma readily encourages this industry consolidation. But not everyone is on board. Two experienced financiers agree both investors and Big Pharma have their reasons for pushing consolidation, but the verdict is still out on to what degree, big is better for the industry as a whole.
-
Biogen Leads Fight Against Supply-Chain Criminals
9/13/2018
Lee Spach, Director, Global Product & Supply Chain Security, Biogen, says there are about 35,000 online pharmacies in the world. Ninety-eight percent are fake. They transact billions of dollars annually and seriously endanger patients. The criminals can expect a large return on their investment, with relatively little risk. Spach and Biogen are trying to change that. You can help.
-
Your Supply Chain At Risk: How To Stay Ahead Of The Villains
8/24/2018
Your supply chain – raw materials and intermediates, APIs and particularly commercial products – is at serious risk from bad actors. We are talking about falsified or stolen materials, counterfeiting, gray-market diversion, and other nefarious behaviors. How can you fight back? Supply chain experts, including from Sanofi and Biogen, offer some sound advice.