In most pharmaceutical QC laboratories, HPLC systems are treated as critical but constrained assets. Despite heavy investments in instrumentation, labs continue to struggle with delayed sample release, long queues, and reactive firefighting. The root problem isn’t always capacity—it’s lack of visibility into losses. This is where HPLC Overall Equipment Effectiveness (OEE) becomes a powerful Operational …
Enhancing Quality Management Maturity in Pharma
🏭 Quality Management Maturity (QMM): Building a Future-Ready Pharmaceutical Manufacturing Site In today’s highly regulated pharmaceutical environment, compliance alone is no longer enough. Global regulators like the USFDA are increasingly focusing on Quality Management Maturity (QMM)—a framework that evaluates how well a manufacturing site goes beyond compliance to achieve sustainable, proactive, and high-performing quality systems. …
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Team Management
"Its easy to get the players. Getting them to play together ,that's hard part"Casey Stengel Team management plays a vital role for effectively control and execute your projects. It's really a big topic to cover but i will take baby step to trigger an essence towards team.There are following stages involve in team management. Team …
Tollgate Review
“If EXCELLENCE is one of your values, not only you self-critic and evaluate your performance consistently, you BEG others for honest feedback...” ― Assegid Habtewold The tollgate review is a formal review process conducted by a champion who asks a series of focused questions aimed at ensuring that the team has performed diligently during this phase. …
Manufacturing Tanks in Parenteral Preparations
Manufacturing tanks are various categories like Mixing tank, Holding tank,storage tank(WFI, Purified water).They are very sophisticated equipment having complex heating and cooling arrangement in jackets to maintain the temperature of vessel.Material of construction for tanks are SS316L and jackets are SS304. Water for Injection Storage tanks should be sterilized at regular intervals so as to …
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Validation of Steam Sterilizer
Sterilization “The act or process, physical or chemical, that destroys or eliminates all viable microbes including resistant bacterial spores from a fluid or a solid.” For Large volume parenterals products sterilization is ultimate steps which assure the manufacturer for complete removal or destroy of viable microbes, basis of successful sterilization cycle. Any sterilization cycle consist …
Filtration in Pharmaceuticals
Filtration is backbone for the sterile drug manufacturing.Sterile products are difficult to prepare and consist of more sophistication than any other dosage form. The drug product which directly goes to systemic circulation (veins,blood vessels, intravenous) shall have no traces of particle size more than 0.2 micron, which can be performed by filtration technique. Filtration is …
The KEPNER and FOURIE™ Thinking Processes
“If I had an hour to solve a problem, I’d spend 55 minutesthinking about the problem and 5 minutes thinking about solutions.” -Albert Einstein We know lot of tools used for root cause analysis and Kepner and Fourie is one of most powerful tool when we don't know the real cause of a problem. The …
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Root Cause Analysis(RCA)
If you are unable to understand the cause of a problem it is impossible to solve itNaoto Kan Now a days pharmaceutical and medical devices industries are getting more number of form-483 from USFDA, due to inadequate investigation of the problems and some time lead to voluntary action(import alert,warning letter) to the manufacturing sites. "The …
Quality Risk Management
"Risk Management is not about future decisions, but about future of decisions that we must take now"Rabert N. Charette Risk is an integral part of life and inevitable. We need to differentiate between positive and negative risks. A positive risk can be an opportunity for the organization and we must have information for positive risk …
