My career in the BioScience/Pharmaceutical/Healthcare industry started at a company that manufactured blood plasma-derived therapies. These life-saving treatments were administered by intravenous injection to immunocompromised patients and during critical care situations. Let’s say the bar was set very high when I was first introduced to the concepts of Quality, Compliance, and current Good Manufacturing Practices (cGMP). Next, I explored the world of consumer health products, including skincare, haircare, cosmetics, and over-the-counter (OTC) drugs (e.g., sunscreens and acne treatments) during my first assignment with PSC Biotech. After that, I delved into Homeopathic Medicine, an alternative treatment method developed hundreds of years ago using small amounts of natural ingredients to enable the body to heal itself. I’ve appreciated the opportunity to learn about these distinct forms of treatment within the health sector.

I was struck by differences in operational and quality standards at each manufacturing site. The extent of automated (versus manual) processes, level of detail in batch documentation, number of Standard Operating Procedures (SOPs), frequency of microbial/bioburden monitoring, and presence of Quality Assurance (QA) personnel on the manufacturing floor all varied considerably.  After all, it makes perfect sense for different strategies and expectations in work environments producing drugs for intravenous injection versus topically applied wrinkle creams.  Nonetheless, as Regulatory Agencies like the FDA keep raising the bar to ensure patient safety and drug efficacy for every product category, all companies must strive to be in better compliance and embrace a culture of continuous improvement.

After writing microbial investigations and manufacturing non-conformance reports for a few years, my focus shifted to the Validation realm. Each company begins Commissioning, Qualification, and Validation (CQV) of their facility, equipment, and manufacturing/cleaning processes with different resources and knowledge.

The CQV Race

When a Validation program does not start by establishing a solid foundation of documented evidence to support their equipment and processes, lots of catch-up work is needed.  Validation is like a team relay, consisting of many moving parts (engineers, subject matter experts, project managers, protocol documentation, execution runs, etc.) coming together to achieve a common goal. Each company joins the race at a unique starting point or notch on the track. Some teams get a head-start, while others are delayed and begin the race at a disadvantage. While every organization puts its best foot forward at the start of the race, each team has a different distance to travel to reach the same finish line.

After being at any job for an extended period, it’s natural to start performing tasks in a certain way that becomes familiar or second nature. These tasks may become so routine that you lose sight of the bigger purpose. Sometimes, it takes the arrival of a new individual to challenge the status quo. Often, there is push-back to ideas or requests, but this can be seen as an opportunity for positive change. This person can offer unique perspectives based on their prior successes and failures.

Each new face brings a diverse educational background sprinkled with work experiences and knowledge applicable to the validation (or quality, engineering, compliance, etc.) project at hand. They will have a good baseline for critically assessing and evaluating the current situation. Going back to the race analogy, this is like bringing in a new teammate whose training approach, pre-race rituals, and pacing technique are different than the rest of the team. Sometimes it is worth a short pause to strategize what changes are genuinely needed before passing the baton and sprinting ahead. When validation (or any type of work) is done the right way up front, it saves lots of time and energy in the long run.

PSC offers consultants with a vast array of experiences in the life sciences. Each consultant can evaluate the current situation based on their unique set of skills and industry knowledge while also utilizing our strong internal network of resources and technical experts within the company. We look forward to undertaking the next challenge and always see it as an opportunity for continued learning, improvement, and growth. Our top priority is to meet the client’s needs so that your company can produce the highest quality products possible. So let the race begin…on your mark, get set, go!

By Kira Rosalsky, PSC Biotech Consultant

Similar Posts