23 Jan
2012

The ABC’s of IQ, OQ, and PQ?

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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’.

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7 Dec
2011

The Dreaded FDA Warning Letter – What it Means and What to Do

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For those of you in the business of manufacturing medical devices or pharmaceuticals, you know all about the importance of following FDA regulations. If, after an FDA audit or inspection, you are found to be out of compliance, you could receive a Warning Letter or an Untitled Letter.

An Untitled Letter is basically a way of citing a violation that does not meet the threshold of regulatory significance for a Warning Letter. A Warning Letter is the most serious of FDA letters, but it’s important to note that it’s not a form of FDA enforcement action. Instead a Warning Letter is just as the name suggests – a ‘warning’ that, if certain corrections or changes are not made, the FDA could take further action.

The intention of the letters is to bring about voluntary compliance without committing the FDA to taking enforcement action. Although there is no immediate enforcement on the part of the FDA, they do expect recipients to make the necessary changes and voluntarily comply with the law. Since Warning Letters are made public under the Freedom of Information Act, it can be helpful to review warnings given to others in an effort to avoid making the same mistakes.

If you do receive a Warning Letter, there is normally a short window (typically 15 days) in which to issue a response to the FDA. The response should include:

1. the steps that have been or will be taken to correct the violations and prevent similar violations;
2. the timeframe within which the corrections will be completed;
3. any reason the corrective action has not been completed within the response time; and,
4. any documentation that shows that correction is complete.

The amount of change that needs to take place to ‘close out’ a warning varies depending upon the violation. If the Warning Letter is in reference to misleading promotional activities, it could be as simple as discontinuing the use of an ad campaign. If, on the other hand, the violation has to do with the manufacturing process of a drug or medical device, there could be a long list of corrective actions that need to be taken. And it may take some time to address them all. In these cases the FDA may decide to withhold certain types of approvals until the issues have been rectified.

Once the violations have been corrected, a Close-Out Letter is issued. This is the official acknowledgement from the FDA that the violations outlined in the Warning Letter no longer exist.

We’d like to hear about your experiences with FDA letters. Have you ever received a Warning Letter? How long did it take before the issue was ‘closed out’?

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28 Nov
2011

The ‘Falsified Medicines Directive’ and Serialization

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The Falsified Medicines Directive published by the Council of the European Union in July is clear legislation aimed at securing the supply chain for pharmaceuticals. But how does this new Directive impact serialization?

First, let’s take at look at the Directive itself. It introduces a number of safety features including:

• Serial numbers and tamper-evident seals for safety packs
• Product traceability through the supply chain
• More stringent rules for the importation of active pharmaceutical ingredients (APIs), plus control and inspections of EU plants manufacturing APIs
• Extended control over the API and medicines supply chain, including improved scrutiny of brokers and traders
• Greater oversight of Internet sales, including an official logo for certified online pharmacies
• More stringent sanctions against counterfeiters

All EU member states have just 18 months to turn the Directive into national law. Manufacturers then have three years be compliant. Although the timetable has been set, there are still some details that need to be finalized. This includes specifics around the unique serial numbers that are required on medicine packs. There is some evidence that it will be the ECC200 2D Datamatrix barcode, but other barcode types and RFID are also being considered.

Whichever method is selected, having an identification and tracking system in place will be the foundation for success for the Directive. This will allow all parties – from manufactures to distributers to pharmacists – to check the authenticity of medication by scanning a unique serial number and checking it against a database. Any duplication of serial numbers or other discrepancies can be immediately flagged and investigated.

As with all previous measures, protecting patients is the fundamental goal of the new Directive. What are your thoughts around the new Directive? Do you think this will be a good way to enforce serialization?

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9 Nov
2011

Reintroduction of the Bill HR3026 To Fight Against Counterfeit Drugs

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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?

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24 Oct
2011

Colour-Coded Syringe Labels Increase Patient Safety

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The statistics are frightening. With all of the advancements in medical science it’s often oversights and human error that lead to death and serious injury – especially when it comes to medical injections.

• Deaths occur in the UK in approximately one in every 200,000 anesthetics administered. http://news.bbc.co.uk/2/hi/health/medical_notes/4966162.stm
• The preparation of injectable medicines is a highly complex process, involving many steps where errors can happen. Problems in preparing and administering injectable medicines account for 62 per cent of all medication safety incidents reported to the National Reporting and Learning Service (NRLS) as leading to death or severe harm (Safety in Doses, 2009).

In the fast-paced world of surgery and medical treatment, it’s easy for a mistake to be made and the wrong medication or dosage to be administered to a patient. To help alleviate this problem, a joint initiative by the Royal College of Anaesthetists, the Association of Anaesthetists of Great Britain and Ireland, the Intercollegiate Faculty of Accident and Emergency Medicine and the Intensive Care Society recommends using a single standard for syringe labelling. The recommendation includes adopting a colour-coded labelling system that is currently used in North America and APAC.

PRISYM ID and Codonics make it easier for hospitals and healthcare providers to adopt these standards, as well as other barcode and labelling criteria, with a safe labelling system for syringes called the Codonics Safe Label System (SLS) 500i. The SLS 500i (designed and manufactured in the USA) was developed by Massachusetts General Hospital anaesthesiologists to prevent intravenous medication errors via barcode assisted medication labelling. The technology scans drug vial barcodes, and prints a full-colour label containing labelling data elements recommended by the initiative. Click here for more information on SLS 500i.

Any steps that can be taken to reduce human error and anaesthetist’s reliance on memory when it comes to administering injectable drugs will be a step forward. We expect the healthcare industry will continue to focus on labelling standardisation, the use of protocols and checklists, and the elimination of look-alike products as a way to help ensure patient safety. What have you observed regarding labelling protocol? Has the new colour-coding system had an impact on safety? Share your thoughts and predictions.

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25 Aug
2011

FDA UDI Regulations – An Updated Look at the Timeline

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In June 2010 PRISYM ID hosted a webinar titled, “Tips for Implementing FDA UDI without Derailing Production”. Featured speakers included Jay Crowley from the FDA and Janice Kite from the GS1 Global Office. The webinar gave an overview of UDI (Unique Device Identification) in practical terms and went through the planned timeline for proposed FDA UDI regulations.

Now that a year has passed, we thought it would be beneficial to provide you with an updated timeline around FDA UDI. While nothing is official, the following is the most recent information on how the FDA UDI rollout might look:

12 Months after the FDA UDI Standard is Published (2013)

The first set of deadlines focus on Class III Medical Devices. These are devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient, such as implantable pacemakers, replacement heart valves, automated external defibrillators, and implants.

• UDI will apply to all levels of packaging
• An engraved UDI may be required for some Class III medical devices
• If a device has a serial number, the UDI will also be serialized

36 Months after the FDA UDI Standard is Published (2015)

The next class of medical devices to be effected is Class II, which are items like x-ray systems, gas analyzers, pumps, and surgical drapes.

• UDI will apply to all levels of packaging

60 Months after the FDA UDI Standard is Published (2017)

The final group is Class I Medical Devices, such as tongue depressors, arm slings, examination gloves, and hand-held surgical instruments.

• UDI will probably just apply to the device (not packaging)

Medical devices are classified by intended use and potential risk to the patient, and as you can see from the timeline above, the UDI regulations address the most critical devices first. The years listed are based on the FDA UDI standard being published in 2012, which is the current plan. Stay tuned!

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