How to Find the BEST Consultant for your Company?
- By: Orlando Alvarez-Fuentes, Ph.D.
- Feb 19, 2018
- 7 min read
Updated: Jun 4
Let's consider the following worst-case scenario: You have received a Warning Letter from the U.S. Food and Drug Administration (FDA) following an inspection. This letter will likely outline the observations that you and your team did not adequately address in your initial response to Form FDA 483. In most cases, the letter will also include recommendations to help you comply with federal regulations. One such recommendation may be to hire a cGMP consultant to assist your company in meeting current Good Manufacturing Practice (cGMP) requirements.
First and foremost, it is essential to treat your Warning Letter with the utmost seriousness. You may wonder why this is so important. The answer is simple: this letter comes directly from your most critical customer, the FDA. A consultant can help your company navigate the complex landscape of federal regulations, paving the way for you to attract both current and prospective clients. Failing to comply fully with these regulations poses a significant risk to your organization, potentially jeopardizing everything you have built. Therefore, it is crucial for you and your employees to remain vigilant in maintaining compliance with Good Manufacturing Practices (GMP) to ensure your company’s success.
If you choose to heed the FDA’s advice and hire a consultant, there are several key considerations to keep in mind to avoid wasting time and money. Initially, it is important to understand that the role of a consultant is similar to that of an FDA auditor. The primary difference is that a consultant will work with you and your employees to ensure full compliance with FDA regulations, while an FDA auditor will gather evidence to demonstrate that your operations violate cGMP regulations, potentially concluding that some of your products are unsuitable for human or animal consumption.
Based on my experience as both a GMP consultant and a Director of Quality who has interacted with various consultants, I have identified nine key characteristics that define the ideal consultants who can provide value to your company. This "value" can be measured in several ways: by presenting solutions for achieving GMP compliance, enhancing the quality of all production processes, fitting within budget constraints, saving time, and ultimately helping to increase sales and revenue.
1. The consultant should hold an advanced degree in Science or Engineering, preferably a Ph.D., although a master’s degree may also be acceptable.
This qualification is of utmost importance because the most effective way to address problems in the production process is through a scientific approach. You want a consultant who is highly trained in the application of this method.
A “scientific approach” refers to the application of the Scientific Method, which consists of the following steps:
Make observations: For example, there is uncertainty regarding the safety of the raw material “Purified Water” used in the manufacturing of product X for human or animal consumption.
Generate questions derived from previous observations: Based on the observations, you might ask, “Is it possible to guarantee the safety of raw material ‘Purified Water’ in my facility for use in products intended for human or animal consumption?”
Formulate hypotheses: A possible hypothesis could be that the safety of products containing the raw material “Purified Water” can be ensured if it consistently meets the following testing parameters: it is a clear, colorless, and odorless liquid with low levels of bacterial, yeast, and mold activity (<100 CFU/g) and the absence of specific pathogens (e.g., E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, and B. cepacia), with a neutral pH and total dissolved solids of no more than 5 ppm.
Develop testable predictions: If the hypothesis is correct, then every time raw material “Purified Water” is tested, the expected results should include a clear, colorless, and odorless liquid with low levels of bacterial, yeast, and mold activity (<100 CFU/g) and the absence of specific pathogens, along with a neutral pH and total dissolved solids of no more than 5 ppm.
Design experiments to gather data to test predictions: Create a validation protocol to evaluate the quality or purity of raw material “Purified Water.” The testing parameters should align with those outlined in the hypothesis, and data should be collected over a predefined period.
Analyze Results and Draw Conclusions: Repeated experiments, such as the one described, will require statistical analysis of the data. The results will inform the next steps to take in ensuring compliance and safety. For example:
-- Scenario I: Every time the raw material “Purified Water” was tested, the results consistently showed a clear, colorless, and odorless liquid with low levels of bacterial, yeast, and mold activity (< 100 CFU/g), as well as the absence of specific pathogens (e.g., E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, and B. cepacia). The water also maintained a neutral pH and total dissolved solids of no more than 5 ppm.
In this case, we can conclude that the raw material “Purified Water” is safe for use in the manufacturing of products intended for human or animal consumption.
I propose to repeat the experiment every six months for the next two years. This will ensure the replication of the experiment, which is another essential component of the Scientific Method. The expectation is that, under the same conditions, the experiment will yield consistent results each time.
-- Scenario II: In this scenario, testing of the raw material “Purified Water” reveals that one or more parameters fall outside the specified limits.
This outcome may indicate the need for an equipment upgrade before repeating the experiment.
The application of the Scientific Method is recommended by the FDA for various purposes, including CAPA investigations, process validation (cleaning, blending, packaging, stability studies), performance qualifications, verification, clinical studies, and the introduction of new analytical methods in the laboratory, among others.
Whenever you have doubts about the credentials of a potential candidate, you can verify their academic qualifications by contacting the Graduate School of the accredited U.S. university or college from which they graduated. This verification typically costs no more than $5.00.
2. Knowledge of the Production Process Flow.
The ideal cGMP consultant should possess a thorough understanding of the production process flow and be able to identify critical quality control points throughout this process. This encompasses everything from receiving raw materials to shipping finished products. A consultant who can pinpoint these critical control points is invaluable for ensuring that Quality Assurance (QA) and Quality Control (QC) specialists can effectively monitor and maintain product quality.
3. Demonstrate resourcefulness.
It is perfectly acceptable for a consultant not to know every detail regarding GMP regulations; this is a common reality. However, your ideal consultant should be able to recognize areas where they lack expertise and, more importantly, retrieve the necessary information from various sources. These sources may include literature, online resources, colleagues, and collaborators.
The same principle applies to meeting deadlines. If your consultant has the knowledge but lacks the time to complete a task, they should be able to identify and potentially subcontract collaborators who can assist in meeting the deadline.
If you decide to hire multiple teams of consultants—whether due to budget constraints or the belief that having more consultants will expedite the process—it's important to designate one consultant to oversee all consulting activities. This oversight will help prevent confusion and ensure that the consulting efforts are coordinated effectively.
4. Should bring with him/her solutions, training and implementation plans.
A consultant's primary role is to provide solutions to your problems. These solutions may disrupt the comfort zone in which your employees are accustomed to operating. Consequently, the consultant will be responsible for training your personnel and overseeing the implementation of these changes. This oversight should continue for a defined period to quickly address any potential errors.
What you want to avoid is a consultant who merely observes from a distance, acting like an FDA auditor and disrupting normal operations. Such disruptions can occur when the consultant assigns multiple tasks to your key personnel—tasks that should be handled by the consultant themselves.
5. Demonstrate empathy.
After the initial protocols are established, including signing non-disclosure and confidentiality agreements and obtaining approvals for business protocols, your ideal consultant should integrate into your company. They should cultivate a sense of ownership and provide constructive advice on the best ways to address the challenges at hand within the allotted time. It is crucial that they avoid non-constructive criticism that could jeopardize your company’s well-being.
6. Blend with Company Culture.
The consultant should be able to adapt to your company’s rules and code of conduct, ensuring a smooth collaboration with your team.
7. Respect for Employees.
Respect for all employees is essential. A consultant should foster a positive working environment and build rapport with your staff.
8. Comprehensive Reporting.
Your consultant should deliver reports that not only document the remedial period but also illustrate how the implemented changes have improved your organization. Documentation is a key element of GMP compliance. For instance, you may produce the best pain relief OTC cream in the world, but if you fail to document the entire manufacturing process, you risk facing a recall that could cost you at least $600,000. Conversely, even if you manufacture a subpar product, having robust documentation practices can significantly reduce the likelihood of a recall.
Your consultant should lead by example in maintaining these documentation standards.
For finished pharmaceutical products, the Code of Federal Regulations (CFR) Title 21 Part 211.34 requires your company to maintain records of any consultants and the services they provide, including their name, address, and qualifications.
9. Fair Compensation.
Consultants typically charge a minimum of $2,500 per week, with rates reaching up to $300 per hour.
Keep in mind that you likely already have a Quality System in place, and your employees should possess the qualifications and expertise to cover the functions that the consultant will oversee. Therefore, the consultant's involvement should not exceed six months, although you can continue to utilize their services as needed.
Fair compensation means negotiating terms that are beneficial for both your company and the consultant. Negotiations are often possible, and your potential consultant is likely willing to work with you in a fair manner. Remember that many consultants are not local and being away from home entails sacrifices.
Note: The SAR Group’s consultants are American citizens and can provide consulting services worldwide.
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