Quality Featured Articles
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Which Laboratory Software Is The Right One For Your Lab?
7/8/2016
To ensure that your requests for specific software and systems receive full consideration, it pays to fully understand the types of lab management software available.
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The Impact Of Waste On The Cost Of Quality In The Pharma Industry
6/22/2016
Waste has a significant impact on the cost of quality (COQ) — or more exactly, the cost of poor quality — in the pharmaceutical industry.
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A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers
6/21/2016
The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.
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Changes To The Opioid Labeling Regulation
5/13/2016
FDA is revising warnings and safety information for immediate-release (IR) opioid labeling. The goal is to inform doctors better about the risks of opioids and how to prescribe these drugs safely.
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How Do You Inspect Packaging Of Bottles, Cans And Cylinders?
5/13/2016
To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.
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Ensuring Bar Code Accuracy From Packaging To The Patient
5/13/2016
For pharmaceutical companies, a barcode helps to assure the origins of the drugs, which in turn helps in minimizing the possibility of a genuine drugs being considered sub-standard or counterfeit.
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3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets
5/4/2016
Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.
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Applying Human Performance Models In FDA-Regulated Environments
4/15/2016
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
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Classification And FDA Regulations: Medical Device, Pharma, Combo Products
4/12/2016
How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product.
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Payer Reaction To FDA Safety Warnings — What Pharma Manufacturers Need To Know
3/16/2016
On October 22, 2015, the FDA released a statement describing updated liver safety warnings for Viekira Pak. Data indicated that Viekira Pak was associated with 26 cases of medication-associated liver injury. Stakes were high in the multibillion dollar hepatitis C (HCV) market, with the fate of one of only two major competing products now unknown. Precision For Value sought to understand the payer reaction by studying payer viewpoints related to a new safety signal in the HCV space.