Sunday, August 21, 2011
The cover of Fortune magazine popped off the newsstand shelf last week: What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.” (August 15, 2011)
Amidst the story that recounted epic boardroom intrigue, one section described the impact that these political shenanigans had on day-to-day decision-making.
“A second anonymous letter, claiming to be from ‘responsible, long and loyal Legal Division employees,’ arrived on the very day of the board meeting. It complained of ‘micromanagement,’ ‘constant’ internal reorganization, and a ‘chaotic’ decision-making process. ‘A decision is made, then reconsidered and changed. Decisions, even minor…are picked apart and often directed to be undone. Then re-studied. Then the decision-making group expands. Paranoia results. Autonomy is sapped.”
When it comes to fuzzy authority and recycled decisions, Pfizer is not alone. Wherever it occurs, at whatever level, the organization is seriously impacted. It matters how decisions are made. Nothing is more revealing about the leadership and the future of an organization than how decisions are made.
One of the most fundamental responsibilities of top management is to align the organization—to get all the oars of the scullers in the water pulling in the same direction. When company leaders compete for the megaphone it becomes, “Stroke, no don’t stroke. Pull left; I mean right—now, anyway.” The course is convoluted, not straight; energy is wasted, not conserved.
When there is leadership dysfunction, there is organization dysfunction and ultimately the patient suffers. Yes—the patient.
Whether it is getting the organization aligned to resolve its regulatory compliance problems, or on time order fulfillment, it is clear lines of authority and crisp decisions that lead us across the finish line.
So, if you feel sometimes you are in an organizational vortex of ineffective decision-making, my recommendations are these:
1. When you accept an assignment, be clear about who are the reviewers and approvers. A good Responsible, Accountable, Consulted, Informed (RACI) model applies here.
2. Establish a charter with a clear scope, lines of communication and decision-making authority. Have your oversight committee approve.
3. Before you are asked to present to your oversight committee, be sure to clarify whether your authority extends beyond recommendations to decisions. If you are the decision maker, walk the committee through your logic.
4. Clarify what decision was made. After the presentation to your oversight committee, sum up the decisions. Don’t leave until every decision is crystal clear.
5. If you were charted with decision-making authority, but your oversight committee takes it out of your hands in a meeting, ask for an explanation. Otherwise, you have no basis of moving forward.
6. Capture minutes of decisions. Whenever you sense that you are having a “Groundhog Day” meeting, remind the participants that the issue had been discussed and decision had been made as recorded in the minutes.
7. If anyone on the oversight committee starts to lobby outside of the committee to change the decision, stop it dead in its tracks. Indicate to that person that the decision was made.
8. When you detect dissention among those of equal authority and it impacts your ability to make progress, meet with them collectively with the stated objective to achieve unified direction.
9. Document a decision timeline. Nothing points to the effect of poor decision-making than a timeline of direction, redirection, and reverse direction. You may need it when you are asked why your project is behind schedule.
10. Protect your team from the effects of poor leadership decision-making. Make forward progress where you can; assume you make the decision. Resist all temptation to promulgate the organizational vortex.
Don’t be the victim of a dysfunctional environment. You may not be able to take complete control, but you can take steps to minimize its effects.
The QA Pharm
Sunday, August 14, 2011
The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. (See The QA Pharm, August 7, 2011.)
Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to regularly review Warning Letters on the FDA website.
Here’s my condensed list of issues the FDA has had with the Quality Unit as seen in Warning letter observations.
This is the list you don’t want to be on.
1. QU failed to establish a system to ensure that…[fill in the blank for anything that went wrong]
2. QU failed to document the responsibilities applicable to the quality control unit in procedures, and fully perform these responsibilities.
3. The personnel performing laboratory tests… were not trained.
4. QU failed to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.
5. QU failed to fully perform and/or document the review of batch production records to determine compliance with all established, approved written procedures before a batch is released or distributed.
6. QU failed to ensure that all tests are in conformance with the established specifications and that these are met prior to the release of drug products for distribution.
7. QU did not review production records to assure that no errors had occurred or, if errors had occurred, that they had been fully investigated, conclusions made and followed-up.
8. QU failed to investigate complaints involving the possible failure of a drug product to meet any of its specifications.
9. Failure to submit NDA-Field Alert Reports (FARs) within three (3) working days of receipt of information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug products
10. And my personal favorite…a designated QU has not been established.
The QA Pharm
Saturday, August 6, 2011
The pharmaceutical Quality Unit has been the target of many FDA Warning Letters as the underlying cause of product quality and CGMP compliance problems. We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA Pharm 9/25/10.)
Therefore, it’s very important to have a clear understanding of the regulatory responsibilities of the Quality Unit and to ensure that those responsibilities are effectively executed.
Remember—the Quality Unit is the only job description that appears in the Code of Federal Regulations!
Here’s my compiled list from FDA regulations and guidance documents that defines the job of the Quality Unit.
(It’s like being given the answers in the back of the book—and not just the odd-numbered problems.)
1. To establish the quality system
a. Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control
b. Keep the quality management system current with good industry practices
2. To audit compliance to the quality system
a. Audit for compliance to policies and procedures: on paper vs. practice.
b. Report quality system performance metrics, including trends, that help decision-making and taking proactive targeted actions
3. To establish procedures and specifications
a. Ensure that procedures and specifications are appropriate and followed
b. Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)
4. To establish manufacturing controls
a. Ensure that appropriate manufacturing in-process controls are implemented
b. Ensure in-process controls are performed during manufacturing operations and results are satisfactory
5. To perform laboratory tests or examinations
a. Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
b. Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor.
c. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions
6. To review and approve or reject all things CGMP
a. Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
b. Review and approve/reject reprocessing and rework procedures
c. Review and approve/reject production batch records and make the final decision to release a product lot into commerce.
7. To ensure investigation of nonconformance
a. Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes
b. Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected
8. To keep management informed
a. Report on product, process and system risks—and keep management informed
b. Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed.
c. Keep management informed—get it?
9. To describe responsibilities in writing
a. Have a complete and compliant procedure that describes responsibilities
b. Follow the procedure
10. To remain independent
a. Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
b. Be independent reviewer and approver with respect to manufacturing and process/ product development units
c. Don’t drink the “Kool-Aid”
Conduct a facilitated off-site meeting comprised of members of your Quality Unit Staff and other operating areas. Walk through this list and ask: “How does our Quality Unit stand up to these requirement?” Develop an action plan.
The QA Pharm
- Federal Register Vol. 43, No 190 – Friday, September 29, 1978, “Preamble to the Drug CGMPs”
- The Code of Federal Regulations Part 210 and 211
- Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (September 2006)