Manufacturers registered with the FDA are subject to spontaneous inspections by FDA agents who will intently scrutinize every manufacturing process for compliance. Manufacturers producing drugs, medical devices, and dietary supplements must adhere to Current Good Manufacturing Practices (cGMPs) to meet FDA regulations. Failure to meet these standards could cause the FDA to order the manufacturer to cease operations until standards are met. The potential costs of such actions to FDA registered manufacturing companies can easily reach into millions of dollars. Some forward-thinking manufacturers are taking preventative actions and hiring FDA GMP consultants to review their processes. The following criteria should be met when hiring FDA GMP consultants, such as, cGMP experience, quality assurance (QA) experience, and a detailed scope of work.
Most FDA GMP consultants will have GMP consulting experience which is an important qualification since they have had opportunities to work with many companies and in different settings. The significance of operational experience, however, should not be overlooked. Industry experience can be just as important as other qualifying factors.Has the cGMP consultant participated in an FDA inspection and is he or she knowledgeable in cGMP regulations? These are good questions to ask when interviewing FDA GMP consultants. Experienced cGMP experts can offer a good range of solutions and offer processes that meet FDA requirements.
The QA department is known for policing the regulated processes for the company. They ensure compliance is met. In order to work in the QA department, an individual requires thoroughness and attention to detail. There is no substitute for QA experience. GMP consultants with QA experience understand how each department in the organization interacts with the manufacturing processes and systems. QA experts have a whole picture in mind when designing a quality management system and are extremely knowledgeable in federal, local, and professional standards.
Detailed Scope of Work
In the pharmaceutical and medical device industry the Scope of Work (SOW) can vary. Some consultants prefer utilizing a vague SOW with not much detail, which can give them some latitude with the work expectations.However, this may also be a clue to their lack of experience. Unfortunately, vague SOWs can lead to frustrated clients that expected certain deliverables at the end of the project. A detailed SOW is a good sign that you are hiring an experienced FDA cGMP consultant. A good SOW should have a start date and an end date (or at least a good estimated end date). Some clients sign SOWs with the assumption that the FDA GMP consultants will start on their project immediately or not take as long to complete the project. The fact is some cGMP consultants do not plan properly and often take on too many projects. An initial meeting with the GMP consultant to discuss the project details should take place. After the meeting, a detailed SOW should outline the items important to the client that will be reviewed or assessed by the cGMP consultant. The detailed SOW should include the deliverables that the client will receive. The deliverables will vary depending on the project details but can be a report of recommendations, standard operating procedures, or equipment validations.
FDA GMP consultants should have cGMP and QA experience and give a detailed Scope of Work. GMP compliance can help prevent contamination, failures and errors. Qualified FDA GMP consultants can help your company plan, implement, and maintain systems to ensure GMP compliance. The good GMP consultants may recommend modern technologies and proven processes to achieve higher quality and more efficient processes. Hiring FDA GMP consultants can prevent costly errors for many manufacturers.
Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483s, cGTPs, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. BRG is regulatory firm providing cGMP, ANDAs, INDs, and NDAs consulting services. The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.