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Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.
Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Managementand Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.
PharmTech: How crucial is it for pharma manufacturers to ensure the safety of APIs? What are the possible repercussions of low-quality and/or ineffective APIs?
Anderson: Much of the world’s supply of pharmaceuticals depends on this critical aspect of the drug product supply chain, and manufacturers around the world shoulder a tremendous responsibility to assure the quantity, quality, and continuity of supply. Unfortunately, the world has seen the impact of quality-compromised API supply chains, resulting in injury and death, the worst possible of all patient outcomes.
PharmTech: What are the steps an API manufacturer must take to ensure quality throughout the development and manufacture of an API?
Anderson:The first step in any supplier acquisition journey begins with a thorough review of the batch release specifications to determine if a given supplier can actually meet customer needs. Soon after, a comprehensive audit should be conducted which is the basic means to determining its status as a quality supplier. What is their cGMP [current good manufacturing practice] status? Those two steps are just [the] beginning of the scrutiny and qualification which have to be ongoing over the life of the contract to make sure that quality is sustained.
PharmTech: What are the steps sponsors should take to ensure the quality of APIs sourced from a supplier used in final products?
Anderson:Sponsors do have a responsibility as well because they too are obligated to assure the quality of their products, regardless of who manufactures their API. All of this boils down to cGMP compliance, not just quality of manufacturing, but the quality systems as well. It is imperative that quality systems are robust, risk-based, and error free. Effective API supply collaboration requires transparency and trust, but that trust must be verified, established from the very first meeting.
PharmTech: International Council for Harmonisation’s Q7A GMPs for APIs touches on all aspects of API production from facilities to equipment to materials management. Of all the areas the guidance covers, is there one particular aspect of API manufacturing that is more crucial for ensuring API quality?
Todas: No. Of course not. CGMP dictates mastery of all aspects of control and quality relative to API manufacture. There is no parsing it, and quality compliance depends on the careful assessment of risk, and the manufacturer’s response to it procedurally and operationally. Your API supplier’s abilities in this regard should be revealed in the audit. If you have a robust relationship with your supplier, you will know where their weak points are, if any, and where you need to concentrate your audit.
PharmTech: What methods are available for testing the effectiveness and safety of APIs?
Todas:Compliance to compound monographs is an established starting point but process analytical controls and processes developed using quality-by-design principles are building in effectiveness and safety into API manufacture, as well as batch consistency from year after year and campaign to campaign.