Driving for Mature Quality Organizations – FDA recent perspective

Theresa Mullin, FDA’s Associate Director for Strategic Initiatives for the Center for Drug Evaluation and Research recently gave a presentation “Update from FDA CDER” at GMP by the Sea (I need to go to that that some-year).

As in other FDA presentations this presentation summarized the Quality Metrics Research Final Report by the University of St. Gallen as the appropriate steps to ensure quality maturity:

  1. Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.
  2. A large percentage of equipment on the shop floor is currently under statistical process control.
  3. For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.
  4. Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.
  5. Manufacturers have joint improvement programs with suppliers to increase performance.
  6. All potential bottleneck machines are identified and supplied with additional spare parts.
  7. For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.
  8. Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.
  9. The firm regularly surveys customers’ requirements.
  10. The firm ranks its suppliers and conducts supplier qualifications and audits.

This are some pretty low hanging fruit. They are also the pretty necessary in any organization, not just pharmaceuticals.

There was also a little discussion on the use of Q10 that really makes me wish I had been there to hear exactly what was said. I hope it was “Just freaking implement it already.”

In general, useful slides, I recommend going and checking them out.

Quality Challenges of Accelerating Investigational Products

Last November, officials from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) met with industry representatives in London to discuss the various quality challenges that arise when the development of investigational products is accelerated .

The report was recently published, and can be found here.

The workshop discussed process validation, control strategies, good manufacturing practice (GMP) compliance, comparability, stability and regulatory tools of early access approaches. Throughout they discussed two elements:

  • Scientific which includes technologies and scientific concepts or principles for development, manufacture and quality risk management, which may or not be present or implied in existing guidelines. Examples include concurrent validation, new modelling methodologies, new analytical techniques, etc.
  • Regulatory/procedural tools are described in the legal, regulatory framework and can be specific to PRIME (or Breakthrough Therapies) (e.g. kick-off meetings) or generally applicable [e.g. Post-approval change management protocols (PACMPs), recommendations, scientific advice (SA)].

I strongly recommend reading the report in it’s entirety.

WHO Revises Guidance on QMS Requirements for National Inspectorates

The guidances that health authorities adopt for themselves can tell us much about what they think is important. WHO recently revised the Guidance on QMS for National Inspectorates to align with international standards and the latest quality management system (QMS) principles and to expand the document’s scope. This guidance is pretty much saying “Get with the times.”

Nothing here is that unfamiliar to folks who are familiar with IS 9001 or most other standards. There are sections on management, management system planning, resources, personnel, infrastructure and documentation. There is a section on a section on operational planning and performance evaluation. WHO states inspections, should be planned in advance and risk management principles should be established for prioritizing inspection.

The document is in it’s comment period through September.

Certified Food Safety and Quality Auditor Body of Knowledge

Every 5-7 years ASQ reviews and updates each Body of Knowledge (BoK) to ensure the most current state of practice is being tested in the examination. Part of the updating process is to conduct a job analysis survey to determine whether the topics in the 2012 BoK are still relevant to the job role of HACCP auditors and to identify any new topics that have emerged since that BoK was developed. Based upon qualitative research with industry experts and feedback from the CHA Job Analysis Committee, food industry knowledge was included in the job analysis survey. The quantitative results of the CHA job analysis survey indicated that all topics from the 2012 BoK are still relevant to common practice and that food industry knowledge is essential to the role of ASQ Certified HACCP Auditors. To accurately reflect the expanded new knowledge and the practice of ASQ Certified HACCP Auditors, ASQ and the CHA Committee have updated the name of the exam program to the Certified Food Safety and Quality Auditor (CFSQA).

 The 2020 Certified Food Safety and Quality Auditor Body of Knowledge (CFSQA BoK) will be introduced at the January 2020 administration. After that, ASQ Certified HACCP Auditors will be renamed and recertify as ASQ Certified Food Safety and Quality Auditors.

 To see the 2020 Certified Food Safety and Quality Auditor Body of Knowledge, click here, and to see the changes between the 2012 CHA BoK and the 2020 CFSQA BoK, click here. Below are some frequently asked questions regarding the update.

 FAQs

Why will the name be changed?

ASQ conducts a job analysis studies to determine what topics in the existing BoK are still relevant to the job role of HACCP auditors and to identify any new topics that have emerged since that BoK was developed. Based upon qualitative research with industry experts and feedback from the CHA Job Analysis Committee, additional food industry knowledge was included in the job analysis study and was subsequently validated by the active CHAs. To accurately reflect the expanded new knowledge and the practice of ASQ Certified HACCP Auditors, ASQ and the CHA Committee have updated the name of the exam program to the Certified Food Safety and Quality Auditor (CFSQA).

 When will the certification program’s title change?

Starting January 1st, 2020, all Certified HACCP Auditors will be known as Certified Food Safety and Quality Auditors.

 What was the scope of change in content within the Body of Knowledge?

No content from original CHA Body of Knowledge was removed, only new content (primarily related to the food industry) was added to the new BoK in the update. View the CFSQA BoK Map for additional information.

 When will the new CFSQA BoK be tested?

The first administration testing new CFSQA BoK will be during the January 3–19, 2020 testing window.

This is a good move. Its definitely good for folks in the food industry as it better defines the certification to material required in food safety.

It also removes the focus on a tool which is of use for other industries (we use heavily in pharma for example). I often found the focus on the tool for a specific industry confusing for those folks who were looking at the tool for other uses. This clarity is good for everyone.

FDA enforcement actions decline

Investigative report on FDA enforcement under Trump from Science’s news department shows a steep decline in enforcement actions.

I’ve noticed this, but it is good to see actual data behind it.

I’ll be frank, it would take a lot of data that does not exist to make me feel the companies under the FDA’s oversight have gotten better as a whole. Anecdotally, well there are a lot of less than sterling players out there.

I have mostly questions:

  1. Have we seen this trend in previous Republican administrations, and is it more pronounced here?
  2. Is there any evidence that the increase under Obama was a reaction to the previous Republican administration? Are we in a cycle of lax and then tougher enforcement that maybe evens out? That sort of variance is not healthy.
  3. What, if any data, will we be able to see about impact? There are certainly concerns that the FDA has not done enough. Will this be exacerbated?
  4. What will it take for this to start affecting the mutual recognition agreements with the EU and other major bodies?