FDA-regulated firms face an enormous task in keeping up with agency priorities and expectations—especially those that have been producing legacy products within an ever-changing regulatory landscape.
Join Govzilla’s Senior GMP Quality Expert, Jerry Chapman, for a comprehensive webinar about assessing legacy products for potential GMP compliance gaps. A detailed description of the session is listed below.
GMP Compliance Issues for Legacy Products
The GMPs as codified in 21 CFR 210 and 211 were greatly expanded and finalized in 1978. Prior to the late 70s, drug candidates were selected using quality parameters of the API such as taste and odor. Stability studies were generally done at lab scale and only run for weeks or months. Scale-up to industrial scale was done by making adjustments to production equipment in a particular plant, adjustments that may or may not have been documented. Little attention was paid to possible interactions between the active and excipients, or to degradation pathways of the active. Hold times were not generally thought about much.
Prior to GMPs in 1978, drug product quality and stability were based solely on finished product testing. Terms such as “validation” and “protocol” didn’t exist until the FDA introduced the 1978 changes to GMPs. Legacy products as defined by The Pew Charitable Trusts in a 2017 report on drug shortages are “previously approved and marketed drugs, typically developed 10 to 20 years ago. Such products typically have multiple competitors on the market and are low-margin.” It is clear that a firm must demonstrate conformance with the rules that were applicable when the product was approved for marketing.
But because a lot has changed–for example, regarding manufacturing technologies, lab analysis detection abilities and regulatory expectations–in some cases, a company will also have to conform to rules that went into effect after the product was approved. The question that will be explored in the presentation is what are the changes that have taken place in recent years that may impact the GMP compliance position of legacy products? And which ones should a company with legacy products pay particular attention to?
• Understand why it is important to assess legacy products for potential GMP compliance gaps.
• Learn where the most likely compliance pitfalls are and how to assess your legacy products.
Who Will Benefit?
This session will be valuable to quality, regulatory, compliance, and management personnel in pharma companies that manufacture legacy products and want to ensure those products remain compliant.
To download the slides, click here!
About Jerry Chapman
Jerry Chapman is FDAzilla’s Senior GMP Quality Expert. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly where he designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the US and internationally. Jerry was founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010.