The story of Gemini starts on Long Island, New York, three decades ago. Back then, Gemini was focused on manufacturing over-the-counter (OTC) pharmaceuticals. As market trends changed and the family-run business passed from one generation to the next, Gemini started doing more and more dietary supplement work. Today, dietary supplement manufacturing is the core focus of Gemini, but its presence in the pharmaceutical industry has left a lasting mark on the company and its approach to quality.
When Gemini started to get into dietary supplements in the mid-1990s, the Dietary Supplement Health and Education Act of 1994 (DSHEA) had laid the groundwork for greater focus on quality in the industry without establishing current good manufacturing practices (cGMPs) for companies to follow. FDA published a final rule mandating cGMPs for dietary supplements in 2007.
That long gap between DSHEA and publication of the final rule — and the phased implementation of cGMPs from 2008 onward — should have given companies time to prepare for the new, more rigorous regulatory regime. Many companies failed to adapt to the new requirements.
Evaluating CMO quality
There are three things a Brand Owner should insist on: supply agreements, quality agreements and batch records. Supply agreements provide a legal framework for the commercial terms and responsibilities of the relationship. Quality agreements set out which party is responsible for what in terms of cGMPs and quality. Batch records provide a complete history of the production of a dietary supplement, from raw materials through to finished-product testing.
Each document is essential to quality partnerships between CMOs and their customers. In the case of the quality agreement and batch record, the documents are key to meeting FDA requirements. Equally, a brand owner that lacks access to batch records has no clue as to the quality of its product. Providing even these basic documents is a problem that persists at some CMOs to this day.
Gemini is an example of a CMO that does things right, be it sourcing quality raw materials, having back up supplies or maintaining documents. The difference in the response of Gemini from other CMOs derives from its history as an OTC pharmaceutical manufacturer.
Whereas other CMOs had to try to create cGMP processes and instill a quality culture from scratch when FDA published its final rule in 2007, Gemini's long history in OTC pharmaceuticals made the transition straightforward. A focus on quality above all else was already ingrained in everyone from the CEO down to new, entry-level appointments. This meant meeting the requirements of the FDA final rule for dietary supplement manufacture was a matter of adjusting standard operating practices to accommodate the dietary supplement regulations.
The benefits of having this quality culture have become increasingly evident in recent years. Since FDA began enforcing the cGMP final rule on all companies in June 2010, it has issued more than 250 warning letters relating to cGMPs for dietary supplements. Close to half of the letters were sent since the start of 2014.
This surge in the number of warning letters is testament to the failure of CMOs, brand owners and own label distributors to adapt to the final rule. Gemini’s focus as a CMO is to ensure its customers and prospects comply with all facets of the regulation.
Forming quality partnerships
Many CMOs produce tablets, capsules and other solid doses to order. Far fewer companies move beyond transactional relationships and create partnerships that give clients and regulatory agencies a transparent look at their operations.
Gemini, the first CMO to initiate a Quality Partnership program, is interested in forming these deeper, collaborative, longer-term relationships. The customer is part of the quality system at the company. This means when Gemini brings on a new customer, the company helps them to understand what goes into making a quality dietary supplement and their role in the process.
Brand owners and own label distributors have a lot at stake when it comes to quality, especially if they outsource manufacturing. FDA sees them, not the CMO, as responsible for quality. As such, it is important for companies to choose ethical, high-quality CMOs and understand the manufacturing of their products well enough to discuss the topic with FDA inspectors.
Gemini helps customers prepare for such discussions by not only providing them with the necessary quality documents, but also training them in how to read the documents. Gemini views brand owners as its advocates to FDA. The better a brand owner looks to FDA, the better all parties look. Consequently, Gemini takes the time to ensure brand owners are prepared for inspections by FDA. The strategy works. FDA has asked brand owners that work with Gemini to explain their quality documents. The brand owners have passed with flying colors.
Such levels of regulatory compliance are far from the norm across the industry. Of the more than 250 warning letters FDA has issued about cGMPs in dietary supplements since 2009, almost 25% refer to batch records. Some of these warning letters were issued to brand owners that failed to review batch records, something that cannot happen under the way Gemini works with customers.
The commitment to quality at Gemini has enabled it to meet the requirements of FDA and other regulators from around the world. Gemini has received cGMP certifications from Health Canada, the Therapeutic Goods Administration of Australia and NSF International, as well as being Certified Organic by Quality Assurance International and certified by the New York State Board of Pharmacy.
This array of certifications and a record of regulatory compliance are testament to Gemini’s drive to be an ethical, high-quality manufacturer that operates in a way that is transparent to customers and authorities alike.