Ineffective Training Programs

This week, I will address the eighth of nine common CGMP Quality System shortcomings; Ineffective Training Programs.

A routine part of any inspection or audit is to evaluate the training program.

Managing a training program is a monumental task. Consequently, I have found few training programs to be well managed and/or effective. Most training programs have a structure in place, but the effective implementation of that structure is often left to each Area Supervisor, who, in turn, may defer the training burden to their subordinates. This training program methodology very seldom works effectively.

In addition, training programs can become a check-in-the-box requirement. This becomes very evident, when re-training operators is a recurring corrective action for non-conformance investigations. I can appreciate the difficulty in effectively training the huge number of people need to perform the very complicated process of drug manufacturing, but a well managed and effective training program that minimizes human error is a critical element in any Quality System.

In reality, ill-trained operators can nullify some in-process controls.

To overcome this shortcoming, the Quality Units should routinely monitor the training program by correlating training effectiveness to encountered nonconformances and deviations.

Resistance to New Technology

This week, I will address the seventh of nine common CGMP Quality System shortcomings; Resistance to New Technology.

New technologies can be a blessing or a curse. New technology has the potential to increase process controls and understanding, which can result in higher efficiencies, yields, and product. Conversely, new technology may also create havoc on established processes if implemented incorrectly or hastily.

New technology is also likely to require heavy regulatory scrutiny, which is a deterrent in of itself.

Therefore, the decision process for implementing new technology must weigh the benefit vs. the costs vs. the risk.

I am sure that we can all agree that every new gizmo should not be employed just because it exists. Likewise, it would be foolish to simply dismiss new technology because the burden of implementation and regulatory approval is significant.

To overcome this shortcoming, the Quality Units should explore the possibility of employing new promising technology, but should also considered all possible quality / regulatory ramifications and thoroughly test the technology before implementing it into commercial manufacturing.

Poor Quality Leadership from Senior Management.

This week, I will address the sixth of nine common CGMP Quality System shortcomings; Poor Quality Leadership from Senior Management.

I strongly believe that a strong quality environment is cultivated from the very highest levels of management. If senior management cares about quality implementation, then all levels of the company tend to buy into “quality matters”.

Inversely, if senior management doesn’t fully appreciate the direct connection between quality management and the bottom line, then a sub-robust quality system is likely to materialize.

A Quality Director isn’t likely to successfully implement a Robust Pharmaceutical Quality System, if Senior Management views the quality function as simple overhead. That Quality Director is likely to meet resistance at every turn and not receive the resources necessary to establish and maintain a health and effective quality system.

Unfortunately, it is unlikely the Quality Director will have the necessary influence to correct Senior Management’s quality short-sightedness, but it probably is worth an attempt. If all else fails, then it is probably best to search out a new corporate quality culture.

Under Utilized Quality Tools

This week, I will address the fifth of nine common CGMP Quality System shortcomings; under utilized Quality Tools.

Modern Quality tools, such as SPC and PAT, can be very beneficial in establishing an effective Quality System. Ironically, many of the quality tools necessary to implement a Robust Pharmaceutical Quality System are already part of most Quality Systems. They just tend to be under utilized.

A significant under utilized tool is the Annual Product Review. I have found that most manufacturers complete this regulatory requirement simply to complete it, as opposed to completing it to gain product/process characterization knowledge. Most of the APRs I have read go something like this, “we produced “X” amount of batches, most batches meet specifications, root causes and corrective actions were completed for those that didn’t, and no negative trends were observed, therefore everything is beautiful and no process improvement is required. What a complete pencil whipping exercise.

Another under utilized tool is qualification/validation studies. These studies are often written to ensure that they pass. The functionality of these studies is to ensure all facilities, equipment, utilities, and/or processes are functioning sufficiently to ensure problems are minimized during commercial manufacturing. As a QA reviewer, I was often frustrated with change control requests that were submitted to fix problems with equipment or processes that recently passed validation activities. In these cases, validation activities were not completed appropriately.

To overcome this shortcoming, the Quality Unit should maximize the return from their established quality tools by complete more thorough and objective analyses and evaluations.

An “It’s Approved, Don’t Improve It” Mentality

This week, I will address the fourth of nine common CGMP Quality System shortcomings; an “It’s Approved, Don’t Improve It” Mentality.

I have found that many manufacturers have a resistance to improving their process because of a potential to impact market supply. Although regulatory hurdles associated with significant processing changes could create difficulties, not making changes for this reason can be short-sighted.

Immediately after licensing a product, most manufacturers shift their focus from gaining product approval to increasing market demand. Once successful, they often experience manufacturing capacity limitations due to their initial efforts to minimize capital start-up costs.

With an emphasis on increasing market demand and manufacturing capacity, proactive and continual product / process improvements are often minimized. When this focus shift is combined with limited initial product/process characterization, product quality can be put at risk.

It has been said that “the process is the product.” A sub-robust process can create significant issues for the most rigorous Quality System. When processing methods, techniques, and materials are not sound, then manufacturing difficulties are bound to surface. Likewise, if the product is sensitive (i.e., susceptible to oxidation), then a robust process becomes essential to assuring product quality.

To overcome this shortcoming, the Quality Unit should not lose sight of the importance of continually evaluating the product and process to achieve a better understanding and to increase the processes' robustness.