Are you an OTC manufacturer that has never been inspected by the FDA? - Are you prepared?

June 27, 2018 Suzanne Konigsberg

By Yuexia Li, Mark Lynch, and Robert Iser
PAREXEL® Consulting

Manufacturers of over the counter (OTC) drugs are required to meet the current good manufacturing practice (CGMP) regulations just as the manufacturers of prescription drugs.  This applies to the OTC companies making finished dosage form (FDF) drugs and active pharmaceutical ingredients (API).  In recent years, the FDA has begun inspecting many more OTC facilities, particularly many that had never been inspected. Common problems and citations found during these inspections of the OTC companies are in the following areas:

  • Lack of quality management system, especially no functional quality control and quality assurance unit
  • Lack of or inadequate process validation
  • Data integrity concerns, including data that can’t be traced and verified, or “making up” data retrospectively to try to fulfill the regulatory requirements
  • Lack of sterility assurance for sterile products
  • Out of Specification (OOS) results that were not handled correctly
  • Lack of an adequate failure investigation process
  • Actual potency in the drug, when analyzed, does not match what is indicated in the labeling
  • Stability data does not support the claimed expiration date
  • Lack of equipment validation and maintenance documentation
  • Failure to analyze for potential contaminants, such as ethylene glycol in glycerin
  • Personnel training was not performed or insufficient training was provided to the employees

The FDA has announced that it will inspect all registered manufacturer facilities before the end of fiscal year 2019. With the globalization of the OTC suppliers, it is not surprising that many OTC drugs are imported into the US, thus many OTC companies were recently put on import alert due to the CGMP related issues observed during inspections by the US FDA.  Additionally, many first-time inspected facilities that have been issued warning letters are OTC companies.  For those “never inspected” facilities, it is critical to take a proactive approach preparing the facility to be “CGMP ready.”  The FDA inspection process is taking a risk-based approach, and having a good “report card” on the very first inspection can put your facility in a very good position.

This is not only a potential problem for international companies marketing products in the US.  Recent acceptance of Mutual Recognition Agreement (MRA) between the US and EU, means that they share inspection results.  Therefore, your potential market in the US and EU may be in jeopardy as a result of inspection from either Regulatory Authority.

PAREXEL® Consulting’s team of subject-matter experts can provide key advice to companies manufacturing OTC drugs on how to prepare your facility to be “inspection ready” to meet the CGMP regulation and expectations from the FDA. If you have been inspected by the FDA and received warning letter, your facility is under OAI (Official Action Indicated) alert status, or you have been put on the import alert list of 66-40, our PAREXEL team can help you to map out the path forward to be on the right track to CGMP compliance again.



Previous Article
What To Consider When Mapping Your Strategy For Submitting An Application To The National Drug Administration of China
What To Consider When Mapping Your Strategy For Submitting An Application To The National Drug Administration of China

Innovative Approaches for Advancing Precision Medicine Development
Innovative Approaches for Advancing Precision Medicine Development