Newsletter | February 6, 2020

02.06.20 -- An Analysis Of MHRA's Annual GMP Inspection Deficiencies Report

 
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  Webinar: 2019 Year In Review
 

ISR is a market research firm operating exclusively in the pharmaceutical manufacturing and clinical research space. In 2019, they conducted approximately two dozen individual pieces of market research for syndication. This webinar will summarize many of the important learnings from these projects, providing attendees with real, usable data for 2020 activities.

Featured Editorial
An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report
 
By Barbara Unger, Unger Consulting Inc.

MHRA took a different approach to publishing the GMP deficiencies for drug product issued during its 2018 inspections, releasing a 6,200+ line Excel spreadsheet in October 2019. This article provides a high-level overview of that data, including additional trends from the two most recent MHRA reports. It also identifies and evaluates the critical and major deficiencies from 2018, citing the chapters and annexes associated with critical and major deficiencies.

Navigating The Regulatory Landscape For Therapeutic Radiopharmaceuticals
By Penelope Przekop and Mark Przekop

There have long been numerous global and local regulations for how nuclear materials are transported, compounded, monitored, and dosed for the purpose of diagnostic evaluation. These continue to be applicable for both diagnostic and therapeutic nuclear medicines. However, establishing therapeutic medical claims for nuclear medicines increases the list of regulations that must be followed.

Industry Insights
Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Article | By Sofie Stille and Elles Steensma, GE Healthcare Life Sciences

Managing the complexities of today’s supply chain begins with transforming relationships that are historically transactional to those that drive suppliers to become value-add partners working toward shared goals with their customers.

Facilitating Validation Of Gas Adsorption Systems Using New Traceable Reference Materials
Article | By Anthony Thornton, Micromeritics Instrument Corporation

Overcoming the challenges of obtaining reference materials for gas adsorption system testing requires a solution that is not only accessible and affordable but also suitable for analysis in highly regulated industries.

Overcoming Challenges Associated With Biologic Drug Formulation And Development
Article | By Victoria Morgan, West Pharmaceutical Services, Inc.

Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high-dose drugs, such as monoclonal antibodies, at high protein concentrations, has created additional challenges, including degradation. Read about how the options provided by wearable technology offer new alternatives that were not previously possible due to historically binding parameters for formulators.

7 Parameters To Consider When Conveying Toxic And Explosive Powders
Article | By Sharon Nowak, Coperion & Coperion K-Tron

In order to maintain the highest standards of safety, sustainability, and hygiene, it is essential that these powders are moved from process to process without any danger to the operatives.

Delivering Flexibility Without Complexity
Article | Automated Systems of Tacoma, Inc.

Next-generation drug products are more targeted and patient-specific by nature, causing batch sizes to be much smaller. This paradigm shift paves the way for more flexible manufacturing solutions.

Serialization: A Road Map To Compliance
Article | Wipotec-OCS

Still looking for a serialization solution? In this case study, one contract packaging company adopted a different mindset and embraced the benefits of track-and-trace capability.

Understanding The Importance Of Punch Length And Cup Depth
White Paper | Natoli Engineering Company, Inc.

This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.

The Effects On Container Closure Integrity Of Freeze-Dried Vials
Application Note | Lighthouse Instruments

Nondestructive headspace analysis is a powerful method for monitoring container closure integrity in finished vials of freeze dried product and for building quality into the manufacturing operation.

Zydis ODT Provides Better Treatments
Case Study | Catalent

Discover how Catalent's oral drug delivery offerings can help get your molecule to market faster. In this case study, learn the many benefits of our product offerings.

Clinical Trial Packaging: Smart Choices Can Trim Timelines
E-Book | Thermo Fisher Scientific

Establishing an efficient drug packaging strategy for a clinical trial is not often recognized as a potential time saver, but it should be. A well-thought-out packaging strategy can significantly cut your clinical trial timelines and increase the likelihood of a successful trial.

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  INTERPHEX 2020
 

April 28 to 30, 2020
Javits Center, NYC

For 41 years, INTERPHEX has proven to be the place to find all of the state-of-the-art solutions you need to cost-effectively develop and manufacture quality product. INTERPHEX is the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can "Experience Science Through Commercialization."

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