After I graduated and got my first job, someone suggested I join ISPE to stay up to date on the latest industry standards and I have been a member since then. ISPE and all the Communities of Practice (CoPs) have been helpful to me throughout my career. If you have a question, there is a CoP with experts who are willing to help you.
Anil recently became Chair of the new Pharmaceutical Compounding CoP. “We want to bring issues of concern to the community and start providing consistent guidance. Every state has its own variance and regulations combined with the FDA’s. We want people to join us for discussions on the current state of the industry. Even if you’re not in pharmaceutical compounding but are in pharmaceuticals or you have some kind of related experience, we’d like you to join the group, as it will help us have robust discussions.”
Anil has more than 27 years of experience in the field and has worked with KMI/Parexel, Centocor (a subsidiary of Johnson & Johnson), Scher-ing-Plough, and Merck. He has validation experience with medical devices and pharmaceuticals in the US and Europe, as well as other countries. As Vice President of Quality & Regulatory Compliance at STAQ Pharma, he specializes in developing quality systems, adhering to regulatory expectations and ensuring safe, timely product delivery.
An FDA-registered 503B Outsourcing Facility, STAQ Pharma provides cGMP prepared and ready-to-administer medications to healthcare providers and patients across the US. STAQ has a particular focus on addressing drug shortages and providing critical medications that are short and in need.
At STAQ Pharma, Anil oversees quality assurance and regulatory affairs at the company’s Denver, Colorado, and Columbus, Ohio, sites. “Every day we send out syringes, pumps, and IV bags of ready-to-administer medications across the country to hospitals. We focus on ‘right first time’ to make sure that we are able to get the product through our processes and to providers and their patients. At our Columbus facility, we’re planning to take on more contract manufacturing opportunities as they present themselves.”
“We would like to help clinical trials, small start-up companies, research efforts, and others that need clinical trial help in making their medications under cGMP. We want to provide support in that area so that if their information, product, and design are correct, it’ll give them leverage to move forward toward larger-scale manufacturing and producing medicines to help patients.”
Anil says one of the most interesting aspects of his current position is predicting what the company will look like in the future and developing strategies to get it there, including leading the company and his team through process improvements.
“We’re trying to move away from more and more paper, because as we grow, the paper process for batch records becomes more of a speed bump. We’ve installed an electronic quality management system that will help us move away from paper and allow us to close out issues quicker. We are always looking at our processes and asking ourselves, ‘What does it look like today and where do we want to go?’ Our team is always trying to get ahead of any issues and resolve them before they become a problem. That’s one of the ways that we add value to our customers.”
