If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs are exactly what they sound like – an annual review of your drug product based on product batch and product yield, customer complaints, recalls, stability data, and validation data just to name a few. ADPRs should be performed in order to maintain compliance with 21 CFR 211.180 and to be in alignment with the FDA’s Guidance for Industry, Q7A GMP for Active Pharmaceutical Ingredients.[1]

There are several benefits and reasons to perform an ADPR on top of checking the compliance box. One of the objectives of an ADPR is to verify the consistency of the process, including looking at critical test results, reviewing batch and production yield, and investigating if any corrective actions or revalidations should be undertaken. This will allow manufacturers to be proactive in their operations and catch any issues before they become disasters. Additionally, reviewing product and batch yield is an opportunity to ensure that processes are efficient and do not cost firms additional money in wasted raw ingredients, APIs, or finished product.

ADPRs should be held by a quorum of management representatives, quality assurance and regulatory affairs personnel, and any member of the team that would be instrumental in necessary trending of drug product performance. It is a narrower focus than your typical management review; it looks specifically at the records for each product individually instead of at larger QMS or production performance.

Some drug products or operations may warrant more frequent product reviews. Some larger firms perform them quarterly, depending on the amount of drug product being produced or if there are existing known issues with a specific drug. You should be performing these reviews at least annually, and have a documented process irrespective of the frequency.

Drug product reviews are not just a requirement of the FDA, other international regulators require them as well. If you need assistance with implementing an ADPR process, EMMA International has a team of experts ready to help! Contact us at 248-987-4497 or email info@emmainternational.com to learn more!


1FDA (June 2018) FDA’s Adverse Event Reporting System (FAERS), retrieved on June 27, 2022, from https://www.fda.gov/drugs/surveillance/questions-an[1] FDA (Aug 2018) Guidance for Industry, Q7A GMP Guidance for Active Pharmaceutical Ingredients retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredientsd-answers-fdas-adverse-event-reporting-system-faers 

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).

Ready to learn more about working with us?

Pin It on Pinterest

Share This