Category Archives: Technology

13Jun/06

FDA Task Force Report Recommends e-Pedigree in Distribution and Addresses RFID Issues

by Daniel R. Matlis

In a long awaited move, the FDA announced on Friday June 9th, that it will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products — “pedigree” — throughout the distribution system.

Consistent with recommendations from the FDA Counterfeit Drug Task Force, the agency also announced that its enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion.

FDA also announced the availability of a Draft Compliance Policy Guide for public comment describing this enforcement approach. By providing guidance on the types of drugs that are currently of greatest concern to FDA, the agency intends to give wholesale distributors a better idea on where and how to focus their initial energies to come into complete compliance with the regulations (21 CFR Part 203) for all the prescription drugs they distribute.

Additional subjects discussed in the Task Force’s report include the following key issues related to electronic track-and-trace that are in need of resolution:
 

  • Technical aspects of the mass serialization of marketed drugs by assigning a unique identifier or serial number to each drug package as the initial step in development of track and trace technology.
  • Importance of a nationwide universal drug pedigree with uniform information in preference to state laws imposing different pedigree requirements.
  • Protection of consumer privacy to prevent unauthorized disclosure of information stored in RFID tags when RFID-tagged drug products are dispensed to consumers.
  • Consumer education about RFID and the labeling of RFID-tagged drug products, to disclose to consumers when they are receiving RFID-tagged products and to inform consumers of the benefits of RFID technology and how consumers’ privacy is being protected.

The FDA has been busy providing guidance and direction on these important topics, now its time for the industry to move implementation into high gear.

 

19May/06

Want to Buy a Bridge? The Promise of Service-Oriented Architecture

By Daniel R. Matlis  

This is an excerpt of my recently published article in Medical Product Outsourcing

Medical device companies have been implementing manufacturing information systems for more than 30 years. These systems were often part of automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs.  For many years, device manufacturers have desired the ability to make production information, processes and resources more transparent. Companies have often looked for ways to unlock operational data to empower decision makers—from operators to plant managers and corporate executives—to make informed, timely decisions.

This level of integration has eluded companies…until now. Today, software manufacturers are moving away from proprietary systems and interfaces and are working together to develop open standards. These connectivity standards have lead to the development of a new class of software, known as middleware. This standards-based software enables the collection, analysis and presentation of critical, real-time data to decision makers throughout an organization. Known as Service-Oriented Architecture (SOA), this technology provides a bridge that allows for the connection of data islands in an efficient and effective manner.  Read the complete article    

12May/06

Don’t forget the Process in PAT

By Daniel R. Matlis  

Do an internet search on Process Analytical Technology and you will be bombarded with sites for companies selling sensors, software and systems claiming to meet FDA’s PAT requirements.
I’m an engineer, and I like gadgets as much as the next person, but technology ought to enable change, not drive it.
Today I see companies following two distinct paths to PAT; one is technological, the other philosophical.

The technological approach to PAT, calls for the implementation of dedicated PAT systems.  This approach generally revolves around a specific technology or set of technology products and relies on a “silver bullet” to achieve the benefits of PAT. This is often driven by sensing or process analysis tools such as SPC, process modeling and process optimization.

This approach often involves the implementation of dedicated data acquisition tools and historians to gather and analyze the data in an information-only, non-validated environment.

The second and more holistic approach requires the development of a PAT philosophy and process across the enterprise. This approach sees technology as a tool to achieving process excellence as opposed to the end goal.

It is founded on mining the vast amounts of underutilized data currently available in automation manufacturing systems, such as SCADA, CIM, Historian, Batch, EBR and MES, It also looks to systems such as LIMS and ERP to correlate process and market data to identify key performance indicators and key process parameters based on historical information. This approach mines the vast amount of existing raw data and transforms it into actionable information through deep process understanding and data modeling.

To achieve the benefits of PAT, Life-Science companies need to design, analyze and control manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. 

Implementing technology before achieving process understanding is like putting the cart in front of the horse.

10May/06

RFID on Prescription Drugs

By Daniel R. Matlis  

On the May 9th issue of Information Week, Mitch Wagner provides some simple and elegant solutions on his article entitled “A Simple Fix For RFID Privacy

In a previous article Levi Strauss proposal to use RFID tags on their Jeans was condemned by privacy advocates. He states “I’m not sure what the heck they’re worried about. I mean, how can you be concerned about privacy protection for information that’s already written on people’s butts?”

Although people may not be concerned about RFID tags in Levi’s Jeans, they ought to be concerned about RFID tags on prescription drugs.

The Food and drug administration (FDA) has issued a report recommending the widespread use of RFID technology throughout the pharmaceutical industry by 2007. The goal is to stem the tide of counterfeit drugs currently available though the internet.

RFID will play a key role in securing our nations drug supply. I can see a day were RFID tags will be the electronic equivalents of tamper proof seals, allowing consumers to rapidly identify counterfeit and fraudulent drugs.

However, there are significant privacy issues that must be addressed.

Would you want anyone with a rogue RFID reader finding out which prescription drugs you are taking?

I certainly would not.

04May/06

Should I Build or Should I Buy?

By Daniel R. Matlis  

If I had a penny for every time I’ve been asked this question…

A company is looking for a customer complaints/ CAPA system. They are considering Building it with MS Access or Buying an off the shelf product?

Are there any special issues with validating such a system compare to in MS Access?

Building FDA compliant applications on MS Access can be problematic. It is especially challenging to meet industry and FDA security requirements with Access as the back-end database.

From a compliance standpoint, building custom software requires you to develop all the documentation for you system from scratch. You must also perform unit, integration and system testing for the application before you move to the qualification of the system (all the Qs).

Compliant Management and CAPA are required by the FDA. As a result, there are a number of mature Commercial Off The Shelf (COTS) products widely used in the industry.

In this particular case I would recommend a BUY with two caveats:

First, make sure you assess and evaluate the vendor’s product to ensure it meets your business needs.

Second, you assess the supplier’s quality system and Life-Cycle practices to ensure they meet your standards. Make sure you perform this supplier assessment BEFORE you buy.

Build a tree-house, buy CAPA software.