Saturday, August 7, 2010

Lean Pharma: First Things First--Just Sayin'

Pharmaceutical companies must comply with the regulations and be efficient. It’s like sending your child to school with a good night’s sleep and a good breakfast. Both are necessary. The company that learns to do both well will survive to compete.

But it appears that pharma is behind the Lean curve.

In the recent article How Lean is Pharma? A 10-Year Progress Report1 the author decries the lagging pharmaceutical industry in average inventory turns saying that there is much to learn from leading-edge companies in other industries.

The author attributes pharma implementation failures to isolated implementation and manufacturing operations focus. He also cites the reasons that cross all industries: lack of leadership commitment, excessive cost reduction focus, improper project selection and suboptimal execution.

I agree.

However, there is a 500-pound gorilla in the room: Lean antagonism toward CGMP compliance, which becomes self-destructive.

Admittedly, my world has been comprised of companies reeling from self-inflicted FDA enforcement wounds. So my sample group is skewed—hopefully.

Here are some common themes that I have encountered when companies cannot seem to harmonize their compliance (CGMP) and efficiency (Lean) efforts.

·       Antagonistic view of CGMPs by management.

Often “GMPs” and “the business” are viewed as at odds with each other. GMPs are a seen as a regulatory burden, rather than an expression of a product quality assurance system for patient protection.

Take for example the site head that gave her employees the mixed message that following procedures is important, “but we must also remember that we make medically necessary products and must do whatever we can to get the batches released.”

·       QA enabling continuous problems.

Rather than designing, implementing and measuring the effectiveness of the quality system and independently ensuring that all requirements have been met, the QA unit rationalizes batch deficiencies.

The QA director whose performance was measured on cycle time is a prime example. He thought he was being customer focused when he released the batch before the product impact of associated deviations had been fully determined—“after all we, we know the product is good, and we cannot interrupt supply.”

·       Lack of robust manufacturing process.

Inadequately developed processes are transferred to routine manufacturing operations to reduce the “time to market” cycle resulting in continuous manufacturing problems and production schedule volatility.

In one company deviations became routine and tolerated. The true root cause pointing to the need for further process development was untouchable, since it could lead to re-opening the NDA or impugn product already distributed.

·       Lack of product knowledge and technical expertise.

Companies have suffered from “brain drain” as a result of “vertical integration,” but there was no analysis of the effect on the scientific and technical capability of the organization. This significantly reduces technical input to improvement projects and permanently engineering out the problem.

An example is the decision made (with inadequate technical input) to retrofit an existing aqueous filling line to fill suspension products in order to decrease the new product launch timeline, which resulted in content uniformity failures.

There is no reason for conflict between Lean principles and regulatory compliance; battle lines do not have to be drawn. I cannot believe that Lean principles seek to destroy a company’s compliance profile with the FDA, or purposefully seek to make uninformed decisions.

I’m just sayin’ it is what it is.

Here are a few suggestions for any pharmaceutical company (not just those in trouble with the FDA) that wants to integrate their compliance remediation and Lean initiatives.

< Start the Kumbaya music, please. >

·       Conduct a thorough baseline CGMP assessment.

Know for yourself where you stand with respect to current industry practice of applying CGMPs. Conduct a baseline compliance assessment that begins with product development and technology transfer, through product delivery to the pharmacy shelf. It is misguided to think that you can start Leaning from a deficient state of compliance. That could only make matters worse.

·       Perform a risk analysis on the compliance gaps.

Based on the results from the baseline assessment, perform a risk analysis for each element of the quality management system in order to prioritize the remediation effort. Consider beginning with document management, change control and employee training systems, since all improvements to other system elements will funnel through these pillar systems.

·       Develop a comprehensive improvement plan.

Create a project plan that becomes one of the highest company priorities. Establish project teams to redesign each element of the quality management system. Ensure they are fully resourced and funded. Track progress through Plan, Design, Implement, and Operate Phases with active governance and phase gate reviews. Determine whether any legacy issues need to be resolved. Remember that the goal is to design a sustainable system. (See The QA Pharm: What is a Quality Management System? Perhaps More than you Think, July 30, 2010.)

·       Use subject-matter-experts to lead the effort.

Use your internal subject-matter-experts (SME) to lead the teams. Go outside the company to get good, results-oriented consultants to avoid the “not invented here” syndrome, particularly for companies that tend to be insular and inbred. In the process, develop “system owners” and develop their sense of ownership.

·       Involve Lean experts to facilitate and ensure efficient system design.

Use your Lean experts to facilitate—not lead—the compliance remediation effort. They can bring a useful perspective and tools that will help to ensure that improved system elements are efficient, while the SME ensures compliance requirements are met.

By it very nature, Lean “takes out.” Compliance improvement more often than not “adds in” because something has been fundamentally lacking.

When Lean is applied without first ensuring regulatory compliance, more can be taken out from an already non-compliant system.

When a compliance system is implemented without Lean principles, inefficiencies and non-value-added activities may go unchallenged.

In other words, put first things first: start with a compliant system. Resist all temptation to Lean a system into compliance. But both are necessary.


The QA Pharm

1 comment:

  1. I'm not so sure borrowing a manufacturing term ("lean") and applying it to compliance is the best take on this. I'd rather re-frame the approach as saying we are taking a risk-based approach to all compliance improvement. So it is a false assumption to say compliance improvement more often than not "adds in" - a risk-based approach may result in "takes out."