Avsnitt
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Every process within a laboratory is producing some type of data. The presented challenges range from vendors servicing a company's equipment holding themselves outside of the company's quality system, to not assuring that the data is true, accurate, concise, complete, and accurate in its entirety when it comes to laboratory data Integrity. Today's FDA regulations scope the electronic data as the true copy of data as opposed to 30 years ago when the hardcopy was the standard. Mitchell Wheeler, senior quality consultant at PharmEng Technology discusses the challenges the industry faces in data integrity compliance and avoiding audit violations.
The Smart Facilities Show,podcast,Integrao,phamatech,laboratory,data integrity,compliance,Mack Powers, FDA, regulations,PharmEng Technology,Mitchell Wheeler,
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In working with some of their customers, Tom Whiteley and his team have been able to optimize existing process CIP systems and offer suggestions about reducing overhead costs. Particularly with water efficiency projects, much of the savings comes by way of lower production times, and energy usage. Some projects can see a 5-20% efficiency boost by optimizing circuitry or piping which can also reduce downtime for manufacturers due to maintenance, accidental exposure, product loss, and operator error.
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Saknas det avsnitt?
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Health authority inspectors are like the rest of us, human. It's not an "us versus them" mentality when interacting with them as we should try to work as a partnership workin toward the same goals. Dr. Wendy Haines explains how to interact with health authorities like the FDA and EPA showing how companies overcome weaknesses in quality systems for laboratory and manufacturing practices.
"Auditors and inspectors are going to look at your documentation and training records because they want to make sure people are trained on your procedures. They want to make sure you're following your procedures because that's a big no-no if you have documentation for laboratory testing or how you manufacture, and you're not following those, because that impacts the quality of the product. So they usually hit documentation, data integrity, cleaning validation."
The Smart Facilities Show,podcast,Integrao,phamatech,Mack Powers,Dr. Wendy Haines,impacting human health,health,toxicology,FDA,EPA,Phd,risk analysis,biosimilar,PharmEng Technology,quality auditor,cleaning validation,QAQC,pharmaceutical,manufacturing,processes,Pfizer,COVID-19 vaccine,
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Dr. Wendy Haines is a board-certified toxicologist with beginnings at the Environmental Protection Agency (EPA) and consultant to the National Institute of Health (NIH), she is probably one of the few experts in her field that have witnessed her manufacturing calculations applied on the pharmaceutical factory floor. Join Mack as he talks with Dr. Haines about her rise in the field of toxicology and how fulfilling her role is on impacting human health.
The Smart Facilities Show,podcast,Integrao,phamatech,Mack Powers,Dr. Wendy Haines,impacting human health, health,toxicology,EPA,Phd,risk analysis,biosimilar,PharmEng Technology,cleaning validation,QAQC,pharmaceutical,manufacturing,processes
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Tom Whiteley explains the critical parts of a Clean in Place (CIP) System as the 4 T's: time, temperature, turbulence, and turbidity. All of which tie into the the wash segment of your CIP cycle. Without these critical pieces of the process, the factor for bio burdens tends to rise putting product and processes at risk of excessive time or contamination.
The Smart Facilities Show,podcast,Integrao,phamatech,contamination,resolving,Mack Powers,Tom Whiteley,resolving contamination issues,CIP,time,temperature,turbulence,turbidity,bio-burden,food and beverage,phamaceutical,biotechnology
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Working directly with manufacturing quality teams, Tom Whiteley and his team aid manufacturers in resolving contamination issues by evaluating the cause of contamination, preventing it from reoccurring, and establishing a redesigned process or configuration to rule out any manufacturing deficiencies in handling parts or a part of the manual processes. At times additional engineering support is needed for process design to refine piping or handling changes with how they do their manual processes. At the end of the day, Whiteley's team figures out how the issue happened and executes a plan to prevent it from reoccurring.
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Sometimes the worst case scenario happens to the most cautious of clients, and a contamination occurs. Tom Whiteley and his team was able to step in and provide engineering support as "extra horsepower" to evaluate where the contamination is causing product loss or extra processing to keep product moving. Remediation solutions can range from an extra deep cleaning, evaluating the process itself, possibly make equipment modifications, to adding equipment or changing the configurations in order to prevent the contamination from reoccurring.
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