Featured Articles
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Over-Encapsulation: Techniques And Challenges Of Blinding Clinical Trial Material
By Capsugel
Over-encapsulation is the most widely used method of blinding supplies in clinical studies, which are larger, more complex, and spread through more countries than ever before. This article reviews techniques for successful over-encapsulation and suggests solutions to common problems.
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Q&A On Contract Manufacturing Trends
By Dr. Jeffrey Reingold, Manager, Research & Development, Contract Pharmacal Corp.
Increased obligations for written procedures, manufacturing operations, and quality control has forced nutritional organizations to invest a great deal of time and capital. The biggest challenge for contract manufacturers of dietary supplements is the requirement for full testing of all active dietary ingredients.
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FDA 101: Product Recalls — From First Alert To Effectiveness Checks
By Food and Drug Administration
When an FDA-regulated product is either defective or potentially harmful, recalling that product — removing it from the market or correcting the problem — is the most effective means for protecting the public. In most cases, a recall results from an unintentional mistake by the company, rather than from an intentional disregard for the law.
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From Discovery To Production, Increasing Operational Efficiencies In The Pharmaceutical Industry
By Kronos Inc.
The global pharmaceutical industry has been one of the most successful in recent history, and as it matures, the industry is responding to the changes that naturally occur within any market: new technologies disrupting traditional business models, growth of generic competition, and a search for high-growth markets.
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Healthcare And The Importance Of Visual Privacy
By 3M Company
The healthcare industry has gone through a data revolution over the past decade. A large volume of healthcare records have now been digitized, and with the passage of the Health Insurance Portability and Accountability Act (HIPAA) in 1996, and the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, healthcare providers, their business associates (lawyers, accountants, etc.), and other custodians of protected health information (PHI) have the obligation to keep patient information safe.
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Sponsor
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Pharma IQ's 8th Cold Chain Distribution For Pharmaceutical Global Forum is the most comprehensive annual meeting for pharmaceutical supply chain professionals to update their operations, technologies, and partners with industry best practices. This year's event focuses on updating operations to comply with global industry and regulatory standards and internationally distributing medicines safely.
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The FDA is taking a closer look at Novartis' Parkinson's drug.
What company was warned that its personnel did not understand their functions in the lab?
Do the benefits outweigh abuse risks for cough suppressant dextromethorphan?
It's all in this week's FDA Update!
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Special Report On Inspection And Quality
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Brochure: TrackWise Enterprise Quality Management System
TrackWise is a fully configurable, enterprise quality management system (EQMS) that defines, tracks, manages, and reports on all critical quality and compliance processes.
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Brochure: Container Vision Inspection Systems
The METTLER-TOLEDO CI-Vision Container Vision Inspection
System is a complete high-speed, stand-alone, empty-
container inspection system. It automatically inspects
empty containers of all kinds, including glass and plastic
bottles, tubs, tubes, cans, and all other rigid containers.
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Datasheet: Granular Inspection System — GVIS-SXX
As the granules fall in the form of a thin layer, the Granular Inspection System (GVIS-SXX) inspects for and utilizes suction to remove foreign particles or hair contaminating the granules. This very unique method of inspecting free-falling granules prevents overlooking foreign particles hidden among overlapping granules.
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Article: Blister Pack Leak Detection — Protecting Product Integrity
The blister packaging process for tablets and capsules is unique to the packaging industry in so many ways. Blister packaging will always exist, due to its practicality, but the things that make blister packaging difficult to work with also make it a desired product presentation.
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Datasheet: Q-DOC Quality Documentation Software
Q-DOC Quality Documentation Software can control, record, and report results for tablet weight, thickness, hardness, diameter/length, disintegration, and flowability, for a paperless production environment.
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Brochure: MET30+ Pipeline Metal Detector
The comprehensive range of the MET 30+ Pipeline Metal Detector is
purpose-designed for contaminant detection in products transported by pipeline — especially foodstuffs such as meat, vegetables, preserves, soups, pet foods, dairy products, powders, or pastes.
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Article: Embracing QbD And PAT
The advent of Quality by Design (QbD) and the Process Analytical Technology (PAT) initiative invites the industry to use its considerable skills to transform process operation and efficiency. One of the keys to this transformation will be a better understanding of powders, since almost all pharmaceutical products are handled in this form at some point during
manufacture.
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Product Sheet: LF-Laser Vacuum Analyzer For Lyophilized Vials
The LF-Laser is a semiautomatic headspace analyzer. The freeze-dried vial is inserted in a test base and automatically rotated to pass in front of the laser for an instantaneous and accurate reading of the headspace pressure and moisture content. The LF-Laser machine is fully computerized utilizing a SCADA platform.
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Brochure: Fortress Pharmaceutical Metal Detector — Tablets And Capsules
The Phantom pharmaceutical metal detector provides the ideal solution for detection and rejection of the smallest contaminants in tablets and capsules. With its current GMP design, and construction suited for FDA compliance, the system meets the stringent QA requirements of the pharmaceutical industry. A free IQ/OQ validation package is included.
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Featured Webinar
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September 15 | 11:00 AM ET
This webinar will highlight the dos and don'ts of preclinical immunogenicity screening and how doing it the right way can strengthen biologic development pipelines by improving the quality, safety, efficacy, and manufacturability of antibodies, therapeutic proteins, and vaccines.
Click here for more information and to register.
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Submission Information
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application notes, white papers, tutorials, videos, press releases, and other relevant content for featuring on www.pharmaceuticalonline.com and in our e-mail newsletter.
For more information, please consult our editorial submission guidelines.
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