This past week I was invited to speak at the Contract Pharma Contracting and Outsourcing Conference in New Jersey, where I spoke on how to sell compliance to senior management.
All too often we assume that compliance is an essential requirement when choosing a critical supplier. And the yet, when cost becomes the deciding factor, compliance becomes compromised or even forgotten for the sake of the bottom line.
Given that more people are hurt each year by toilets than receive FDA warning letters or FDA-483s, the threat of FDA enforcement is hardly a credible compliance encouragement. And so I opened day two of the conference by speaking on how lean FDA compliance can:
- save money
- enable greater revenue and profitability
- simplify compliance
- and generate easy metrics to both support those results and prove effective compliance to FDA.
I was followed by Addam Reynolds, a Consumer Safety Officer with FDA's New Jersey district office who spoke on recent FDA inspectional findings and trends. Mr. Reynolds summarized a number of trends in FDA-483s, comparing the previous year to this one. I've reproduced two of his summary tables below.
As we looked at the data, Mr. Reynolds made several explanatory comments of what was behind the numbers.
First, many of the new investigators now with FDA are well-versed in laboratory and manufacturing operations. A number of new hires have come from those laid off by the pharma industry - an irony not lost on attendees. With increased familiarity of modern-day manufacturing and laboratory settings comes increased scrutiny. Thus the increases in citations for noncompliance with 21 CFR 211.63 and 211.160(b)(4). Mr. Reynolds noted that "Firms are either not qualifying their equipment and instruments at all, or are not doing it right."
Second,the number of citations for 21 CFR 211.68(b), controls over computerized systems, is, in Mr. Reynolds insight to FDA thinking, "really about data integrity and data security." This continues FDA's special enforcement of Part 11 as a rule governing electronic data and records integrity; an enforcement approach that was officially announced in 2010. As Mr. Reynolds noted, most Part 11-relevent 483s happen because firms continue having systems "with little to no data integrity controls."
As I've written about extensively, been interviewed on, and consulted on, Part 11 is less about validating computers per se, and more about ensuring data integrity. To that point, validation is simply a means to an end. The most recent issue of my client newsletter, SmarterCompliance #68, explains in-depth how to use data mapping as a technique to simplify and streamline Part 11 compliance.
The rest of Contract Pharma's conference featured more excellent speakers on various contracting and supplier management issues, including site selection criteria, what to do when your CMO goes bankrupt, and more. If you've not attended this two-day conference before, I encourage you to do so next September. Attendees and speakers are focused on frank conversations about overcoming real-world challenges. I'll be there speaking. I'm thinking of doing something on parallels between choosing a puppy and choosing a supplier - lessons learned and puddles cleaned.
If you're looking for more lean compliance events, check my upcoming workshops and speaking events page on my website. In the near term, I'll be speaking:
- September 25 - webinar on overseeing and verifying Part 11 compliance of your records at critical suppliers
- October 3 - Part 11 enforcement today for OTC manufacturers
- October 11 - webinar on best practices for quality system management reviews (a new requirement under the new EU GMPs Chapter 1 going into effect in January)
I hope you'll join me at one of these events.
