Is Industry Failing to Learn From Past Quality Mistakes?

 Written by Nancy Tomoney - Associate Validation Manager, QPharma

For several years now the FDA has not only published Warning Letters, but also significant Form 483’s in an attempt to educate industry on commonly observed issues.  It seems a portion of industry isn’t paying attention, as there are common problems being repeated over and over again throughout the industry at unrelated companies.  In looking at both Warning Letters and Form 483s available to the public, the questions are raised:

•    Is industry focusing too much on the risk-based approach and not enough on true compliance? 

•    Are we more concerned with profit than with quality?

•    Why are we not learning from the mistakes of others?

In 2002, the FDA issued Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century — A Risk-Based Approach.  The document outlined these goals:

1. Encourage the early adoption of new technological advances by the pharmaceutical industry;
2. Facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance;
3. Encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas;
4. Ensure that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science;
5. Enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by further integrating enhanced quality systems approaches into the Agency’s business processes and regulatory policies concerning review and inspection activities.

It seems every few years another company ends up in Consent Decree.  The Warner Lambert/Parke Davis and the Wyeth Consent Decrees preceded the FDA document. Schering-Plough’s came at the same time Pharmaceutical CGMPs for the 21st Century was issued, and more recent companies have entered into Consent Decrees, the latest being Genzyme. 

Genzyme’s Consent decree comes in parallel with significant cGMP issues at the Johnson & Johnson McNeil facility in Fort Washington, PA.  The issues observed at both Genzyme and McNeil are similar to those found in

some of the other industry posted Form 483s that date back to 2002.  Genzyme’s issues go back several years and other Warning Letters have been posted showing similar issues at smaller companies within industry. 

In the Fall of 2008, the FDA made some initial updates to the GMPs published in 21 CFR Part 211.  Most of those changes focused on aseptic processing and on microbiological control.  Many of the recent Warning Letters, including Genzyme’s and the McNeil 483, show a lack of compliance with microbiological contamination and control, not only for sterile or microbiological controlled products but for nonsterile products made with ingredients with microbiological specifications.

Is there a portion of industry that cannot assess risk correctly?  It appears as such based on the actions that FDA has needed to take against industry.

Who is responsible for not doing their job?  Industry, the consumers, and some of the politicians blame the FDA; they have too much to do and not enough people to do it.  The FDA blames industry and the politicians; industry is not being responsible and the politicians are not adequately funding the Agency.

The blame finger gets pointed over and over again.  The public never hears about all the companies regulated by FDA that are in compliance and are being proactive in keeping up with their cGMPs.  They only hear about the failures.  The Agency is now in a mode of transparency initiatives.  Part of the new FDA transparency is to post the inspection findings by category, OAI – official action indicated, VAI – action indicated and OBS – Observations, for each regulated business inspected by the Agency.  I am not sure whether this is a good idea or not, it might be more information then the public can handle.  Industry may not be helped by it.  The United States of America versus Barr was 17 years ago, and industry, some of its biggest names, can’t seem to stay in compliance with the cGMPs.

We keep seeing the same repetitive cGMP failures; not only at small and medium sized companies but at the largest and most experienced players in industry.  In the mid 90’s when the FDA posted sweeping draft changes to the cGMPS, we came together and agreed to abide by those rules and police ourselves.  However, the risk based method of quality, when not implemented properly, seems to be leading to less quality, not more or better quality.  We essentially end up with less effective policing.  “Staying in compliance” and “quality first” should be our mantras. 

Noncompliance is expensive; it’s profitable to those that come in to “clean up” and bring the site into compliance.  Lawyers, auditors, contractors, consultants, and third party overseers make money; the noncompliant company sees profits shrink.  It’s time to change that and return to a focus on quality.  Industry needs to pay attention this time.  Look at Genzyme and look at McNeill; the FDA isn’t backing off; it’s time to learn from our past mistakes and get back on the quality track.