Archive for 2012

Apr 12th

Posted in FDA, Industry News, Labeling Regulations, Life Sciences News, MHRA, Medical Labeling

Decoding the Methodology Minefield

Methodologies are certainly a minefield of regulations, acronyms and terminology; and that’s even before you get into what it all means, how to implement them or how to manage change.
Let’s start with the regulations. Whether you are talking about manufacturing or shipping, there are certain regulations that apply. In terms of labeling, the US FDA regulations are the most onerous, so if you can meet these you are generally equipped to meet any others you come across (including EU and MHRA regulations).

Acronyms can add a layer of complexity, since they can be very similar with only slight variations on each other, such as cGMP, GMP, GAMP and GxP. Fortunately, there are some standard letters that are used, which makes deciphering some of these acronyms a bit easier. For example, ‘G’ is often used for Good and ‘P’ for Practice or Practices. Another commonly featured letter is the lowercase ‘c’ which stands for Current if it’s at the beginning of the acronym. When ‘A’, is found in the middle of the acronym it’s for Automated, followed by the area that is represented, such as ‘M’ for Manufacturing, ‘C’ for Clinical and ‘L’ for Laboratory. Collectively these are all known as GxP, where the ‘x’ in the middle indicates there are many different unique areas the overriding methodology can be implemented into.

When you get further into your project you will likely need to enforce control and manage change by utilizing either Software Development Implementation and Maintenance (SDIM) or Systems/Software Development Lifecycle (SDLC). They both include a detailed Computer Systems Validation and a Change Control process to ensure safe and efficient management. Both SDIM and SDLC cover the full project lifecycle from the initial idea through design, test, deployment, (including any iteration for change) and the final phase. The change management process has its own set of relevant terms, starting with Continuous Improvement, Kaizen or Six Sigma, all of which aim at long term improvements in an operational or manufacturing process. If an issue is uncovered, a different set of tools and techniques can be used to investigate and remove or rectify the issue. These include Root Cause Analysis, Corrective and Preventative Action (CAPA), and Poke-Yoke (Japanese technique also called Error Proofing).

A Quality Assurance and/or a Quality Management System will help you deal with the overall aspects of planning and control and should incorporate the relevant GxP methodologies as well as some tools and techniques used within the change management process. Relevant accreditations, for example ISO, will fall into this area.
Have you managed to successfully navigate the methodology minefield? Do you have experience with SDIM or SDLC? Share your advice here.

Mar 13th

Posted in FDA, Industry News

Breaking Down FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 compliance has become a common topic for today’s life sciences companies. The abbreviation we have become so used to is short for “Food and Drug Administration Code of Federal Regulations Part 11 Electronic Records; Electronic Signatures”. The last four words really sum it all up.

These guidelines are focused on the use of electronic records and electronic signatures for life sciences companies, such as Pharmaceutical, Medical Device, Biotech, Biologic, Clinical or Contract Research Organizations as well as other FDA-regulated industries. In short, life sciences companies need to implement controls for software and systems involved in processing electronic data that include audits, system validations, audit trails, electronic signatures and documentation. Companies that need to comply are those that ‘manufacture’ in or wish to ‘import goods’ into the United States.

The guidelines go on to define the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures. The FDA states that Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.
The relevant records, as well as documentation for the systems, must be available for inspection by the FDA. In order to pass inspection:

• Signatures need to be two part (username and password)
• Relevant validation documentation needs to be in place
• Labels and data need to be strictly version controlled
• Relevant SOP’s must be in place
• An audit history of actions needs to be maintained and secure
• Actions within the system need to be permission based

Of course, if you don’t want to deal with Part 11 and all its components, the alternative is to keep “hard copies” of all required records. If you choose this option, the paper documents are considered to be the authoritative document for regulatory purposes so the computer system doesn’t have to meet the Part 11 requirements.

Any tips on how you are working within the FDA 21 CFR Part 11 guidelines? Have you been through an FDA inspection? Share your thoughts with us!

Feb 21st

Posted in Healthcare Solutions, Labeling Regulations, Medical Labeling

The Evolving Global Healthcare Market

As with most industries, the healthcare industry has undergone numerous changes over the past few years. Economic pressures, stringent government regulations and the advent of new technology have all combined to change the way the healthcare industry conducts business. But what has had the biggest impact?

Economic pressures have had an effect on the way pharmaceutical companies and medical device companies sell their products. There is a lot more emphasis on total cost of treatment, and that makes it increasingly difficult for these companies to differentiate themselves in the U.S. and other established markets. In response, pharmaceutical companies and device manufacturers have started venturing outside of their home countries. Emerging markets, especially China and India but also Brazil and Russia, are adding one billion new patients into the global healthcare system.

While the economy has made things more difficult for the industry, technology has made life a little bit easier and can actually aid in saving costs. Online services, whether it’s ordering supplies, managing product lifecycles or tracking clinical trials data, have become more efficient with the use of tablets, such as the iPad. Health professionals have embraced tablets for their ease of use, portability, and range of uses from data entry, to viewing medical images, to accessing online reference materials and databases. For clinical trials they are already being used for electronic data capture as well as journal entries.

The last area we will look at – compliance – will continue to be top of mind for the healthcare industry, as companies face the threat of potential fines and scrutiny from regulatory bodies. The evolving regulatory environment has impacted the way these companies do business – from labeling requirements and barcodes, to tracking and tracing medical devices and pharmaceuticals through the various distribution channels. As new guidelines come out and deadlines creep closer, this struggle to keep counterfeit drugs and products off the market will continue to shape how the healthcare industry manufactures, labels, packages and distributes its products.

What do you think has had the biggest impact on the healthcare industry? Is it compliance and regulatory issues, a difficult economy or advances in technology? What do you think 2012 will bring?

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’.