As part of our special edition on contract manufacturing we asked three CEOs of leading CMOs (contract manufacturing organizations) for their top tips they give brand owners for qualifying a contract manufacturer.
Michael Finamore, CEO of Gemini Pharmaceuticals Inc., went with five tips:
1. Have them fill out a manufacturing questionnaire that outlines their quality program.
2. Audit the facility to insure they have a robust quality program and are following it throughout all stages of their manufacturing process.
3. Put in place a Quality Agreement, outlining the core responsibilities each party will have during their relationship.
4. Implement a Supply Agreement to provide certainty and a degree of transparency throughout the development and manufacturing processes particular to the items.
5. Require batch records, quality documents and information concerning changes to the products and related processes to be regularly provided to you - not just during an FDA audit.
Jared Leishman, CEO of Capstone Nutrition, said that they advise their customers and prospective customers to focus on the following three attributes in assessing a contract manufacturing partner:
1. Quality Assurance – The contract manufacturer should have a robust management system in place, including a dedicated quality assurance team. Brand owners should check what certifications the contract manufacturer holds and ensure they have accreditation for all the jurisdictions where the goods will be sold.
2. Customer Service – Brand owners should assess the equipment and expertise of a contract manufacturer to ensure they can fulfill performance commitments.
3. Competitive Pricing – Brand owners should ensure the pricing is competitive and correlated to the level of quality and customer service sought.
Steve Holtby, President & CEO, Soft Gel Technologies, Inc, went with:
1. Is your company FDA cGMP compliant, and if so, who has certified you?
2. Everyone can make a good product when everything goes as planned. What are your procedures to handle unexpected problems such as testing issues, raw material shortages, etc.?
3. Can I come today and visit your facility?
“It is critically important to pay close attention to the Quality Unit and to monitor how decision-making is implemented throughout the production process—from procurement of raw ingredients to the final release of finished products,” added Holtby. “This is the most essential part of a contract manufacturer. If a weak QA/QC presence is observed, the rest of the processes will have the likelihood of being incomplete, not in compliance and just downright bad.”
Supplier qualification
Supply chain management and integrity have been thrust to the fore in the dietary supplements industry over the past 18 months. Much has been made of GNC’s botanicals raw materials GMP guidelines, for example, but is that affecting how contract manufacturers do business, and are they qualifying their own suppliers differently as a result of this?
Quality & Supply Agreements defined
Brand owners should ensure they obtain both quality and supply agreements with their contract manufacturer.
Quality agreements are to determine the minimum standards by which the product has to be produced and the required steps to be taken to ensure product quality, explained Capstone’s Leishman. Supply agreements may contain quality standards but speak more to the terms and conditions by which the contract manufacturer and the customer agree to work under.
“Both of these agreements are critical in today’s business environment to protect each party and establish a foundation for a successful relationship. By spelling out expectations and deliverables up front, the chances of issues later on are minimized and business continuity is greatly improved,” he said.
For Gemini, the biggest change in the past two years is most raw material brokers have to invest in their quality systems because product specifications are becoming more rigorous, said Finamore. “This eliminates their ability to multi-source raw materials and forces them to be more cognizant of their factory relationships and supply chain,” he said.
“Gemini has always maintained a strict supplier qualification program that includes a robust vendor questionnaire requiring significant information about the company and its products, audits of their facilities, and rigorous testing of all lots of material using the most modern technologies, including HP-TLC, UPLC, and ICP-MS.”
Leishman said Capstone has always had a rigorous qualification process in place for its suppliers, which it updates continually to meet changing regulations and the needs of its customers.
“Capstone has always been proud of the fact that we are a leader in the areas of testing and regulatory compliance. We do our best to anticipate regulatory changes and issues and manage them proactively.”
For SoftGel’s Holtby, the question should be, ‘how much responsibility should the contract manufacturers assume for testing?’
“Some contract manufacturers still rely almost solely on the raw material supplier’s stated results on a certificate of analysis,” he said. “However, it is vital that contract manufacturers develop their own protocol for testing and qualifying individual batches of raw materials, as they carry a good chunk of end product responsibility.
“Dealing with the qualification of raw ingredients and their suppliers is difficult, because raw ingredient suppliers are not held to the same regulations as the dietary supplement manufacturers,” he added. “For example, it’s common for distributors of raw ingredients to not perform all the necessary testing needed. In this case, we would perform (or arrange) the testing ourselves. We not only perform standard analysis on finished softgels such as micro- and active- ingredient testing, but we also do extensive testing on raw materials for identity, potency, and contaminants where applicable, to assure ourselves and our customers that the ingredients we use are viable.”