Yes, there is a light at the end of the long, dark COVID-19 tunnel, and people’s lives will return to a state of normalcy. However, what will the new state of normalcy look like in a post COVID-19 world? Will it return to business as usual, or will adaptations made during the pandemic be forever incorporated into our lives?
The COVID-19 pandemic has forced drug and device companies to change the way they do business to continue manufacturing life-saving therapies and preventive treatments while keeping employees safe and ensuring the safety of their products. Regulatory agencies understood this and enacted their authority to support emergency preparedness and promote the development and availability of these products during the pandemic. Some of these actions included the implementation of guidance documents for industry, enactment of Emergency Use Authorizations (EUAs), and the use of enforcement discretion in applying otherwise applicable Good Manufacturing Practices (GMP) requirements for certain industries (e.g. hand sanitizer and personal protective equipment).
With unprecedented commitment from the industry and regulators, the development, commercialization, and distribution of therapeutics and vaccines is under way to provide relief to the COVID pandemic. At such time when the public health emergency is officially declared over, regulatory agencies intend to discontinue the enforcement discretion policies and withdraw the guidance documents and EUAs. However, the recommendations described in FDA’s Guidance to Industry for GMP Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing are expected to remain in place beyond the termination of COVID-19 until it is revised and/or replaced with any appropriate changes.
Some of the businesses that have been operating under the relaxed enforcement discretion will be seeking to move from manufacturing and distribution during the COVID-19 pandemic under an Emergency Use Authorization to a permanent business model with full GMP compliance as a requirement. When this happens, companies in this position will need to take a few steps to ensure they remain in compliance with regulatory requirements.
Below are a few steps that companies operating under relaxed enforcement discretion under an EUA can take to be prepared for making the switch to a permanent manufacturer and be inspection ready!
It is never too early to prepare for a post COVID-19 world, and manufacturers of drugs and devices need to be ready, especially if they are operating under an EUA. It may seem like a daunting task, but ProPharma Group is here to quickly and efficiently work with you to ensure you are fully GMP compliant and inspection ready. Contact us today to get started.
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