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Granulation is one of the most important unit operations in the production of pharmaceutical oral dosage forms. However, there are many different technologies each having different strengths and weaknesses. Most [...]

This paper is the fourth in a series discussing various aspects of sampling. The first paper in the series, 'An Introduction to General Sampling Principles: Reducing Bias and Variation in [...]

This is the second in a series of articles on the development of a GXP training system. The first paper was titled 'Developing a New Employee Orientation Program for GXP [...]

ABSTRACT In this paper, a brief introduction of Chinese GMP with respect to legislation, guidelines, and the GMP certification system is given. This is followed by a comprehensive comparison of [...]

Have you started using your floor for filing space? Has the top of your desk gotten lost under piles of paper and to-do lists? Now is the time to get [...]

DA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper [...]

When an FDA inspection is imminent, it pays to have a plan. Start by getting your paper in order and your facility in a state of good repair. Train a [...]

The Autumn 2009 issue of the Journal of Validation Technology (JVT) continues to showcase new columns, expert articles, and peer-reviewed papers. The following are highlights of what this issue has [...]

As the U.S. healthcare industry continues its evolution from paper toward electronic medical record-keeping, a trend is emerging: The payers are leading the way, but the consumer ultimately will benefit […]

I keep a daily work journal, which helps get the frustration out on paper. Sometimes reading what I've written makes all he difference--I'm able to recognize that the cause of [...]

ON PAPER, the challenge in the South Carolina managed care market is pretty obvious: South Carolina has about a 5.8% managed care penetration rate, compared with the national average of […]

The only place in your plant that will still need paper. Corporate description Werum Software & Systems is one of the worldwide leading suppliers of manufacturing execution systems (MES) and [...]

Every member of your practice team can help increase security. Discuss these seven steps to get started: 1. Lock up anything valuable, including money, purses, wallets, and important papers, and [...]

[ILLUSTRATION OMITTED] Primedia Enterprises announced three strategic partnerships to launch creative brand extensions for its craft titles, Creating Keepsakes, Simple Scrapbooks, and Paper Crafts. Via a deal with Leisure Arts, [...]

'GLP Forum' addresses topics of interest associated with good laboratory practices. We intend this column to be a useful resource for daily work applications. The key objective for the column: [...]

Welcome to 'Supply Chain Forum.' Control of the supply chain is an extremely important topic in pharmaceutical and medical device manufacturing. Supply chain involves all aspects of product manufacturing to [...]

SUCCESS IS a funny thing: not everybody gets to enjoy it, but everybody sure seems to have a theory on how to achieve it. 'You make your own luck.' 'Timing [...]

Key to a strong licensing industry are companies that partner together to generate product that is on trend, priced right and on shelf when the customer wants it. What follows [...]

US Food and Drug Administration officials are moving aggressively to address the charges of incompetence and ineffectiveness that have roiled the agency in recent years. In January 2009, the Government [...]

The US Food and Drug Administration made effective 21 CFR Part 111 cGMPs for Dietary Supplements on August 24, 2007. This regulation replaces the Dietary Supplement Health and Education Act [...]

'Global Regulatory Viewpoint' addresses regulatory and compliance topics including newly published regulation. This column discusses regulatory information from a global perspective. The content in this column is useful to those [...]

'GLP Forum' addresses topics of interest associated with good laboratory practices. We intend this column to be a useful resource for daily work applications. The key objective for the column: [...]

[ILLUSTRATION OMITTED] Brand Licensing Europe, which is the only pan-European event dedicated to licensing and brand extension, will attract more than 4,000 visitors from 60 countries to the two-day event [...]

RON SEIDNER thinks the slowdown is no excuse for shoddy dealerships; on the contrary, a smaller market should result in fewer but better stores, he says. And the bigger the [...]

The License! Global Top 100 licensing companies accounted for almost $160 billion in retail sales of licensed products out of the total market of almost $192 billion worldwide. In a [...]

CLIENT EDUCATION, COMMUNICATION Career toolkits Assist veterinarians with giving career day presentations to classrooms and encourage children and young adults to pursue careers in the veterinary profession. FutureVet toolkits are [...]

INTRODUCTION For the health sciences profession today, the benefits of assessing and managing risk have extended primarily from patient safety to the entire product life-cycle--from development through delivery Various organizations, [...]

The Third Annual Top Global Licensees special report features the key data of 125 prominent licensee companies from every major product category. License! Global expanded the list again this year [...]

This article addresses changes to processes and the revision of standard operating procedures (SOPs). Emphasis is put on the necessity of SOP revisions. An illustrative problem is presented as an [...]

INTRODUCTION This article provides a description of a method for assessing risk to product quality during the development, manufacture, and processing of pharmaceutical and biological products. There are a number [...]

CLIENT EDUCATION, COMMUNICATION Educational tools for children AVMA offers a series of career tools designed to enhance student interest in science and veterinary medicine. The materials target grades K-12 and [...]

This column presents statistical principles useful to practitioners in compliance and validation. We hope it will become a useful resource. Barriers to the understanding and use of statistical principles include [...]

This issue of 'Global Regulatory Viewpoint' discusses self-inspection programs in the pharmaceutical industry and associated considerations with Kevin O'Donnell of the Irish Medicines Board. Note: The views expressed in this [...]

ARE YOU A PRACTICE MANAGER WHO'S STRUGGLING to communicate with your practice owner? You're not alone. I get calls every week from managers who feel like owners don't respect them [...]

Inspecting punches and dies can be time-consuming and costly for tablet manufacturers. Advances in technology, however, have greatly improved in process inspections. The author examines improvements in equipment and computer [...]

Welcome to 'Global Regulatory Viewpoint.' This column addresses various regulatory and compliance topics including newly published regulations. This column discusses regulatory information from a global perspective. The content in this [...]

The number of instruments and devices on the periphery of processing systems can easily number in the thousands. As a result, it is important to implement a naming convention for [...]

EXECUTIVE SUMMARY Recent documents and discussions have emphasized a comprehensive and integrated approach to the validation of manufacturing processes--the lifecycle approach to process validation. This approach comprises process understanding derived [...]

Welcome to 'Global Regulatory Viewpoint.' This column discusses regulatory information from a global perspective that will be useful to those who deal with pharmaceutical development, regulatory submissions involving chemistry, manufacturing [...]

Recent developments in the ongoing concern over the safety of products imported from China have created pressure on the US Food and Drug Administration (FDA) to improve its inspection of [...]

P.T. BARNUM once famously said, 'Without promotion, something terrible happens--nothing.' The folks at Mike's Cycle World must have been listening, for they seem to know that promotions are one of [...]

As an industry we are not very computer savvy, even though we have used many tools over the years that are technology- (computer-) based. Our lack of confidence with computers [...]

Very often, when a vehicle is involved in a collision, there is a high probability that the front or rear suspension components of the vehicle may also have sustained damage. [...]

Many shops have come to realize that most of their business is done at the front end of the shop. Because that's true, how well your office functions greatly determines [...]

As far as Michael Howe is concerned, the healthcare community should no longer question whether retail clinics are here for the long haul. The way he sees it, the criticisms […]

Over the last five years, we have made strategic changes to our Leading Licensors list to ensure up-to-date, accurate worldwise retail sales estimates. This year, we made yet another change. [...]

The licensing industry is daring to take on a new genre of art that vastly contrasts the conventional art themes seen on the shelves of traditional retailers worldwide. Flaunting an [...]

This guidance was developed within the Expert Working Group (Q7A) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been [...]

Have you, the regulatory compliance auditor, ever been questioned regarding the basis for your findings? Have you ever wondered whether some of your findings were even worth mentioning in a [...]