Is There a Right Way?!

As a parent of two youngins (Lord help us when we get to the teen years!), I’m often wondering how we’re doing . . . is there a right way? Are there “good practices” to follow? Not really. Sometimes I wish I could open a book to find answers, but at the end of the day, there are no rules to parenting. We all have to do what we feel is best for OUR kids and US. Quite the opposite of my career. Being highly regulated, those of us in the bio/pharmaceutical and medical device industry have lots of rules to follow (Total downer, I know!)! But there’s good reason . . . our health and safety.

Our industry is “ruled” by GxPs . . . good practices, with the “x” meaning manufacturing, clinical or laboratory. Regulations are established by the FDA and published in the Code of Federal Regulations. The preceding “c” that is sometimes seen (i.e. cGMP) stands for “current,” current Good Manufacturing Practices because these guidelines/regs are always evolving, so we have to keep paying attention! Similarly, although there’s no “rule book,” the world our children are growing up in is also constantly changing, and we have to evolve with the times and teach/parent our children based on the world around us.

So, why is this all so important in our industry? Lack of compliance can lead to having a product pulled off the market or getting a delay on a market approval. Let’s avoid those scenarios and ensure data integrity by following these good practices:

GLP (Good Laboratory Practices)

  • to be followed when conducting nonclinical laboratory studies that support applications for research or marketing for products regulated by the Food and Drug Administration;
  • to assure the quality and integrity of the safety data filed (most efficacy studies are non-GLP);
  • regulations cover all aspects of nonclinical studies such as (but not limited to) personnel, facilities, lab equipment, test and control articles, protocols, and reports.

GMP (Good Manufacturing Practices)

  • to be followed for methods, facilities, and controls used in manufacturing, processing, and packing of the product;
  • to assure the product is safe for use, and that it has the ingredients, purity and strength it claims to have;
  • regulations cover how to build strong quality management systems, using quality raw materials, developing solid operating procedures, properly handling product quality deviations, and maintaining reliable testing laboratories.

GCP (Good Clinical Practices)

  • to be followed when conducting clinical trials with human subjects;
  • to assure that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are validated;
  • regulations cover designing, conducting, recording, and reporting trials involving human subjects

A few common mistakes made by sponsor companies… leading to potential disaster

Inadequate training for personnel

This is commonly seen. In general, training is a great way to cut costs and many feel you can “get by” without it. Not true. Spend your money here. If not, you may deal with issues such as, inadequate validation procedures, inadequate CAPA (Corrective and Preventative Action), inadequate quality audits (just to name a few). All of which can lead to the FDA issuing the Sponsor company an FDA Form 483 . . . essentially a form that notifies the Sponsor company after an inspection of observations that may constitute violations of the Food Drug and Cosmetic Act.

Avoiding investment in appropriate technologies

Many companies are still a bit old-fashioned and very “manual,” with paper systems. Technology is expensive and that’s another easy way to say “no” and think you’re saving costs. But what about all of the time and efforts you’re paying staff to manually do all the work? How about investing the $$ into efficient and automated systems that will streamline processes and save you TONS of time and effort and MONEY on your personnel?

Lack of enough quality personnel

It’s a lot of work to manage Quality systems and efforts. Many companies have a plethora of administrative personnel, but lack an efficient number of those required to maintain compliance and Quality within the organization. Avoid 483s and product recalls by hiring the team you NEED for an effective, efficient, and quality compliance program.

Learn from others mistakes! You’ll be ahead in the end!

Toto's Tips

  • Spend $$ where it’s important; cutting costs isn’t always a good practice in the long run.
  • Start compliance programs/systems early on. It’s fast/easy for things to get out of hand. It takes lots of time and $$ to go backwards and “clean up,” versus keeping things clean from the start.
  • Streamline and automate tasks! Saves man hours, saves money, reduces human error.