Pharmaceutical Technology EPR Monthly Issue:
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Pharm Tech
April 18, 2018
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PRODUCTION TRENDS

Keys to Manufacturing Data Integrity

The Parenteral Drug Association's Data Integrity Task Force helps industry members understand the expectations for data integrity.
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INTERPHEX Keynote Education Series Sponsored by PharmTech:

Data Integrity Keynote Series: experts will discuss regulatory requirements for data integrity and best practices for data integrity and process security.
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Blockchain and Serialization Keynote Series: Experts will discuss information technology including the internet of things, blockchain technology, and serialization.
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Interphex
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FROM THE ARCHIVE: DATA INTEGRITY BEST PRACTICES

Navigating Data Integrity in the Modern Lab

Understanding the role of both people and technology in the maintenance of data integrity in the analytical laboratory is crucial as companies move toward predominately electronic systems.
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Data Integrity Challenges in Manufacturing

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
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Data Integrity Best Practices

Electronic systems allow biopharma manufacturing companies to meet data integrity requirements and optimize practices.
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Establishing an Effective Data Governance System

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
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PACKAGING

New Equipment and Software Meet Needs for Fill-Finish, Serialization, and Data Traceability

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.
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More Packaging

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IN THE NEWS

Jim Miller Presents Contract Services Keynote at CPhI North America 2018

Jim Miller, veteran industry analyst and founder/former president of PharmSource, a GlobalData company, will explore 20-years' worth of changes in the contract services market during his keynote address at the CPhI North America conference on Wednesday, April 25, 2018 in Philadelphia, PA.
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Editor's Picks

Service Aids Design and Installation of Cleanroom Systems

Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.
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Quaternary Diaphragm Pump Improves Drainability

The QF10k pump from Quattroflow is a positive-displacement quaternary diaphragm pump with a patent-pending chamber design.
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Equipment Showcase

World's Fastest Capsule Filling Machine

Fette Compacting's new FEC40 Capsule Filler produces up to 400,000 capsules/hr – nearly twice that of any other capsule filler. This dramatically elevated output is accomplished in a remarkably small footprint, making machine reconfiguration due to floor space unnecessary. The high performance-to-footprint ratio is due to Fette Compacting's patented Duplex Concept, which utilizes a mirrored capsule filling process and double-sided discharge.
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Leistritz manufactures twin screw extruders and systems for continuous mixing/devolatilization of API's with excipients. Lab scale and production scale equipment is available, and applications include melt extrusion and granulation. A variety of upstream and downstream equipment is available. Services include a process NJ development laboratory and ongoing training/workshops.
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Aphena Pharma Solutions offers a blackout suite for manufacturing products that are light sensitive and must be made in a contained environment. The suite features special yellow lighting and thick white curtains backed with black material to keep ambient light from entering the room. Aphena can run up to 250-gallon batches inside this suite in its cGMP environment.
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The Syncade MES accelerates batch release times while ensuring reliable and repeatable production processes in a fully regulated environment. The Syncade MES provides innovative technologies that combine document, equipment, and materials management with electronic work flow to create a manufacturing environment optimized for operational certainty every day.
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UPCOMING WEBCASTS

Improve Data Transparency and Collaboration Across your Manufacturing Network
Live Webcast: Wednesday, April 25 at 10:00am EDT
Register now


Dose Design: Bridging Early- and Late-Phase Development
Live Webcast: Tuesday, April 24 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
On Demand
Learn more


Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
On Demand
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EVENTS

CPhI North America

Apr. 24–26, 2018 | Philadelphia, PA


IVT's 19th Annual Computer and Software Validation Conference

Apr. 25–27, 2018 | Philadelphia, PA


more events

eBOOK

Vaccine Development and Manufacturing 2017 eBook

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.


download the eBook
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