Pharma regulation: The more things change, the more they stay the same

By Hank Rahe

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Corporations are in a constant state of change, moving from one approach of managing business to another. Within regulated industries, such as pharmaceutical, the relationships between regulators and the companies they regulate are a classic example of the old saying, “the more things change, the more they stay the same.”

As the wheel of change revolves, regulators and regulated companies continually “partner” to save time and money on behalf of both parties. This “partnership” grows until one party violates the trust; and as this happens, the regulators and the regulated company begin to distance themselves as an adversarial relationship begins to emerge.

What causes a solid, trusting, working relationship to change to one of distrust? It could be due to the many small changes that occur as a result of becoming too comfortable in the relationship.

Companies are continually making small operational changes to reduce costs by removing levels of supervision, expanding personnel roles and reducing the role of proper training. Likewise, regulators, who are faced with cost pressures, may not conduct inspections with enough depth or frequency.

These seemingly small changes by each party can mask the early warning signs of problems in the manufacturing process or testing of the products.

Although processes and testing are documented and validated, individual experience still plays an important role in the complex world of pharmaceuticals. Operational proficiency by individuals can only be gained by proper training, reinforced by doing the task a number of times.

Training budgets and time to properly train are the keys to creating and maintaining a qualified work force—and the key to maintaining the relationship.

Making training a priority

Individuals' career development involves different assignments to satisfy short-term, personal growth objectives. The rapid movement of individuals through assignments often results in a loss of valuable experienced-based information in the jobs these individuals take for a short period of time.

When companies and regulators are in their comfort zones, it's easy to make changes that reduce cost and frequently move personnel. But these seemingly small changes create cracks in the solid systems, and mistakes will occur.

Most mistakes involve documentation and procedural errors, which inexperienced individuals may not notice. Rapid turnover involved with the process tends to mask an existing problem until it grows into a major quality issue that can put the drug's users at risk.

As mistakes are identified by regulatory audits, a feeling of distrust quickly develops on both sides. The regulatory agency feels the company has abused the leeway given to them, while the company feels that the regulators are becoming too restrictive. Each party overreacts, creating a gap that quickly widens.

Enough already

Regulators place a higher level of scrutiny on company operations and impose demand for corrective action; the regulated company then denies that the small changes have created a problem and attempts to rationalize their position. Both spend far too much time and effort fixing something that should have never happened if good judgment had prevailed.

The wheel continues to turn, the cycle repeats itself, and the balance is tipped in favor of more regulation—until the burden of the increased regulation causes someone to say “enough.”

At this point, the balance begins to shift once again to either reduce regulation or self-regulate. How many times must this cycle repeat itself before a balance can be achieved?

Hank Rahe is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board. He can be contacted at: [email protected]


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