Newsletter | September 3, 2019

09.03.19 -- Is Your Personnel Hygiene Plan Up To Date?

Featured Editorial
Is Your Personnel Hygiene Plan Up To Date?
By Mark Durivage, Quality Systems Compliance LLC

Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

4 Trends In Recent FDA Warning Letters To OTC Drugmakers: And How To Avoid Them
By Alan D. Greathouse, The FDA Group, LLC

A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.

Industry Insights
Selecting The Best Pharmaceutical Mixing Equipment For Your Operations
Article | By Ken Langhorn, Charles Ross and Son Company

Finding the right mixing equipment isn’t as simple as selecting an item from a menu. This article is a guide to considerations when choosing pharmaceutical mixing equipment and vendors for a facility.

Putting The “Process” Into Process Characterization
Article | By Daniel Sayut, Lisa Rives, and Evan Pasenello, AbbVie

Done correctly, process characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to process characterization that has been proven effective as it has been used to support the approval of several marketed products.

The Value Of Digital In Biopharma
Article | By Emmanuel Ligner, GE Healthcare Life Sciences

By working together across the biopharma industry, digital technology can be leveraged and data science can reengineer key elements of the drug manufacturing process to ease commercial scale-up.

Current Innovations In Contained Manufacturing
Article | By Michael Avraam, ChargePoint Technology

Establishing an effective containment infrastructure is key to any production involving HPAPIs, and managing the manufacture of new and reclassified HPAPIs is placing increasing pressure on existing manufacturing facilities. Read about procedures and new technologies that can assist you in meeting your high potency handling requirements and ensure the safety of your employees.

Utilizing Pneumatic Technology To Build High-Performance Liquid Dispensing Systems For Lab Automation Applications
White Paper | By Craig Correia, Festo Corporation

W Pressure-controlled liquid dispensing systems provide a simple, quick, and cost-effective way to dose nanoliter-to-milliliter-scale volumes of fluid with precision, reliability, and scalability. In this white paper, we’ll explore the basics of designing a pressurized dispensing system — including how to manage flow, pressure, and other control variables to optimize your throughput in these critical applications.

How To Survive An FDA Audit
White Paper | By Paul Dupont, Ropack Pharma Solutions

Understanding the FDA audit process, preparing for it, and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

Risk Mitigation Of Parenteral Packaging With Container Closure Integrity (CCIT)
White Paper | By Oliver Stauffer, PTI Packaging and Inspection Systems

Pharmaceutical parenteral delivery systems are the highest-risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a significant threat of bacterial ingress as shown in research by Kirsch et al. in 1997. To manage this risk, the industry has continued to pursue leak detection methods that are more sensitive and reliable for vials, ampoules, cartridges, and syringes.

Industry Trends In Biologic Formulations
Article | By Victoria Morgan, West Pharmaceutical Services, Inc.

In 2018 we saw a record-setting year for new molecular entity (NME) approvals (59) at the FDA versus 46 in 2017. Fifty-eight percent were for orphan drugs (patient population less than 200,000 in the U.S.) with 17 biologic-based NMEs. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.

Key Quality Considerations When Launching A Product Into The EU
Q&A | A Q&A with Dawn Douglas, Almac Group

Read the latest Q&A from Dawn Douglas, qualified person at Almac Pharma Services. This Q&A looks at the key quality considerations when launching a product into the EU. Topics discussed include what the role of a qualified person involves, key milestones when launching a product into the EU market, and quality licensing requirements when launching a product into the EU.

Controlling Complexity (Not Cost) Of Advanced Therapy Supply Chains
Article | Thermo Fisher Scientific

Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety are demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.

The Definitive Guide To Porosity Characterization
White Paper | Micromeritics Instrument Corporation

This paper takes an introductory look at the techniques used to investigate porosity, the data generated, and their strengths and limitations for specific materials, covering more complex approaches such as the Reverberi method and the application of nonlocal density functional theory (NLDFT) to illustrate the necessity for, and potential benefits of, more advanced analysis.

The Importance Of A Good Nonviable Measurement: Real-Time Viable Particle Counter
Application Note | TSI Incorporated

A nonviable airborne particle counter is a misnomer. Current airborne particle counting technology, such as found in the TSI AEROTRAK™ particle counters, size and count all particles that pass through its viewing volume. It does not matter whether the particle is viable or nonviable.

  Clinical Trial Supply East Coast 2019

CTS East Coast 2019 will return to King of Prussia, where large and small pharma and biotechs will have the opportunity to discuss, debate, and consider new technologies and processes to streamline supply chain operations. With multiple solutions providers exhibiting their solutions and copresenting, this meeting promises to showcase best practices and techniques that are translatable into practice.

Rotary Tablet Press: NP-400
Natoli Engineering Company, Inc.
Cap Sealing Machine
Daiichi Jitsugyo (America), Inc.
Keylajet Cleaning Detergent: Low-Foaming High Alkaline Liquid
Alconox, Inc.
100 L Integrated HyPerforma Single-Use Bioreactor With Controller
Thermo Fisher Scientific
Webinar: Smarter Development Of Chromatography Processes

September 24, 2019 | 11:00 AM EDT

Smart process development is a collection of approaches to make process development better and faster — providing the developers with tools to face the rapidly changing landscape. This webinar will review three fields that enable reduced timelines and improved outcomes of process development activities:

  • In-silico process development and data-driven decisions
  • Management of process variability through deeper process understanding
  • Use of high-throughput methodologies
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