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…”
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
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:
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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