Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a long disclaimer “this is the opinion of the individual and in no way reflects the opinion of the Agency, etc.” I have found that the exception to this statement is FDA Warning Letters.
When a Warning Letter names inspection observations against a company’s sub optimal quality management system you will most likely find a direct recommendation at the end of the report. “CGMP Consultant Recommended…”
- …While you indicated in your response that your firm will cease drug manufacturing, you did not provide information on how you will ensure that none of the products you continue to manufacture are drug products. We recommend that you engage a consultant qualified to help you identify which products are drugs, so you can meet your commitment to cease all drug product manufacturing.
Additionally, if you intend to resume manufacturing drugs for the U.S. market in the future, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The consultant should aid you to address all the above issues systemically and assist with comprehensive corrective actions and preventive actions before you resume any drug product manufacturing. 1
- …FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation. 2.
- …Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. 3
The purpose for FDA’s explicit direction in these cases is based on what the inspector observed during the visit, the inspector finds that the firm lacks the discipline and quality culture to remediate the deficiencies on its own. Deficiencies that can lead to an unacceptable level of risk for adverse patient impact.
Consulting firms can provide a non-biased perspective to resolving issues, which is especially important when a company is entrenched in old ways of doing business. Other benefits of a third-party consultant in this situation are many, to name a few: consultants have the past experience and insight into what quality system strategies work well in pharmaceutical settings and what pitfalls are to be avoided, consulting firms also can provide dedicated resources to efficiently and effectively implement quality solutions to nonconforming issues, and in cases where trained personnel headcount resources are limited, consulting firms can easily adjust to the resource level needed.
For companies that are seeking to enlist the services of a consulting firm some key attributes to consider are:
- Depth of experience in providing remediation services.
- Ability to communicate effectively, external communication to agency and internal communication to the firm, including the ability to educate and train staff on new or revised procedures or processes.
- Flexibility – Understanding what the issues are and finding workable solutions that are appropriate for the firm. Too many consultants have a narrow mind and may not present solutions that work for the culture, phase of development, operations, etc. I have experienced some consultants that are immutable to new processes. E.g., the “my way is the only way” philosophy. It is not a one size fits all industry.
- Understanding of risk, how to evaluate risk and assess its impact on like systems and processes.
While the use of a consultant does not relieve a firm’s obligation to comply with CGMP, the use of a consulting firm does enhance your ability and chances for success in resolving quality system deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Regardless of the specific situation you are experiencing, whether you need to respond quickly in order to protect the future of your product and company or if your quality system is simply in need of a tune up, the Compliance consultant experts at ProPharma are ready to assist you in achieving these goals.
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References:
1 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yino-inc-578566-08122019
2 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/results-rna-llc-578997-07292019
3 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/westlab-pharmacy-inc-dba-westlab-pharmacy-585571-06262019
