Archive for the ‘Industry News’ Category

Jan 23rd

Posted in FDA, Industry News, Knowledge Base, Medical Labeling, PRISYM ClinTrial, PRISYM Medica

The ABC’s of IQ, OQ, and PQ?

LOL, and OMG….today everyone knows what these internet slang terms mean and how to use them.

If you are reading this blog you may also be familiar with Medical Device and Life Sciences specific acronyms for example IQ, OQ, and PQ. For those who are new to the very specific world of Life Sciences, we’ll try to debunk the myths around some of the terminology.

So what is meant by IQ, OQ, and PQ? They are terms that fall under the category of validation and verification.

IQ stands for “Installation Qualification”. The IQ records the installation of the software, and ensures that the installation follows the correct steps.

OQ stands for “Operational Qualification”. The OQ tests or qualifies that the solution is working using test data in general. This maps across to the requirements stated in the Functional Specification, and ensures the product or application meets all the predetermined requirements as stated.

PQ stands for “Performance Qualification” which means that the application, under real life conditions, consistently produces products which meet all predetermined requirements. The PQ is the final test before production (potentially the most important test document you will ever run), testing that the solution works fully in the live environment using live data, and should be based back on a workflow model from your User Requirements Specification.

On top of the IQ/OQ/PQ, you should ensure that you have other key documents including The Validation Master. This will form the detail and coverage of the documentation that you need.

Last thought for the day is that validation requires documented evidence, if the validation process is not documented then it cannot be proven to have occurred. Put another way, your regulatory body will view your validation process as solely a ‘rumour’.

Nov 9th

Posted in Industry News, Labeling Regulations, Medical Labeling

Reintroduction of the Bill HR3026 To Fight Against Counterfeit Drugs

Counterfeit drug revenues were estimated to be in the region of $75 Billion in 2010 and are projected to grow at 13% annually. The World Health Organization stated that it is impossible to quantify the size of the problem but that it may be as much as 10% of the global market.

The scope of the problem in the U.S. is small compared to what other countries like Nigeria and the Ukraine experience, but is the U.S. doing enough to keep out counterfeit drugs? Do you think the current laws we have in place are working?

Just last month U.S. Congressmen re-introduced the bill HR 3026-Safeguarding America’s Pharmaceuticals Act. This bill provides a way for authorities to track, seize and destroy counterfeit drugs before they enter U.S. households. This bill contains several important requirements such as:

• Creating a uniform national pedigree system
• Developing a tracking system, using bar codes and radio frequency tags to enable drugs to be followed
• Authorizing the FDA to destroy seized counterfeit drugs

Are you surprised that a bill like this is NOT already in effect in the U.S? Do you think this bill will pass?

Aug 16th

Posted in Events Calendar, FDA, Industry News, Knowledge Base, Labeling Regulations, Life Sciences News, Medical Labeling, PRISYM Medica, Technology News

IQPC Pharmaceutical Serialization and Traceability 2011 – Geneva

We are looking forward to attending IQPC’s Pharmaceutical Serialization and Traceability conference coming to Geneva in November. The conference will focus on topics that are very important to us, such as patient safety and anti-counterfeiting.
One of the featured speakers for the event, Janice Kite, Director Healthcare Traceability for GS1, participated in our “Tips for Implementing FDA UDI without Derailing Production” webinar. At the Geneva event, Janice’s presentation, “Traceability and Product Serialization Standards and Harmonization”, will cover key worldwide regulatory and industry developments, GS1 Standards for Healthcare, how GS1 standards assist in compliance to the Directive for Falsified Medicines and the standardization strategy across Europe and Internationally.
The conference will also have industry speakers from the EFPIA, APB and PGEU, GIRP and HIBC as well as from manufacturers AstraZeneca, Roche, Boehringer-Ingelheim, GlaxoSmithKline, Daiichi-Sankyo and Abbott Laboratories.
If you are planning to attend this event, be sure to use ‘19085.002Prisym’ to get a 20% discount on the standard conference prices. You can register in one of three ways:

Go online: http://www.pharmaserialisation.com/Prisym
Call: +44 (0)207 368 9300
Email: enquire@iqpc.co.uk

May 24th

Posted in FDA, Healthcare Solutions, Industry News, Labeling Regulations

Pharmaceutical Cargo Theft – It’s Only Getting Worse

In April 2010 the U.S. Food and Drug Administration (FDA) sent a letter to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products. (more…)

Apr 18th

Posted in Industry News

What Direction is the FDA Heading with Track-and-Trace?

The drug industry was in a track-and-trace coma until the FDA’s publication of the final guidance on a Standard Numerical Identifier (SNI) for pharmaceutical packages in March 2010 woke them up. Manufacturers no longer have to wait until the January 1, 2015 deadline set by California to see what the accepted practice will be.

(more…)

Mar 11th

Posted in Industry News, Medical Labeling

Serialization Survey – The Results are in!

It is well known that the counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety.  This is a global issue that doesn’t recognize borders of trade agreement and its supply chain is fast to react to new opportunities.

(more…)

« Older Entries