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.
7 Tips to Help You Prepare
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!
- Be prepared. While regulatory authorities temporarily postponed routine on-site surveillance inspections of facilities and clinical trials, they are still being performed for mission critical inspections, such as pre-approval and for-cause inspections. Once travel restrictions are relaxed, regulatory agency inspections will no doubt be reinstated with renewed vigor.
- Perform a GMP Gap Analysis. Compare your current organization, personnel, facility, equipment, product control, process controls, warehousing and distribution, records and reports against current FDA and applicable regulatory standards. Always remember that a drug or device that is not manufactured, processed, packed, or held in conformity with current good manufacturing practice to assure that the drug or device meets certain quality and purity standards is considered adulterated.
- Review GMP requirements and recommendations related to facility and equipment cleaning, sanitation, and microbiological controls. Most companies are in a heightened state of diligence during the pandemic, and it is recommended that manufacturers perform a risk assessment of the current microbiological/viral control strategy to determine if mitigation strategies will still be necessary after the public health emergency. It is possible that enhanced cleaning and sanitation may become the new standard.
- Perform an audit of your current Quality System and confirm that the procedures currently in place meet regulatory requirements. For medical device manufacturers operating under an EUA, for face masks or respirators as an example, the quality system should comply with 21 CFR 820 and ISO13485:2016. For hand sanitizer companies, the quality system should comply with ICH Q10 Pharmaceutical Quality System and ICH Q7 Good Manufacturing Practice Guidance for Pharmaceutical Ingredients.
- Ensure Quality Control Testing is in place with verified/validated methods. For example hand sanitizer is considered an Over the Counter (OTC) drug by the FDA and must have full USP testing and Certificate of Analysis as well as long term stability testing in place. Face/surgical masks must meet ASTM F2100-19 testing standards.
- Analyze your supply chain and make sure critical vendors are qualified and meeting the requirements of approved quality agreements. As an extension of the company, FDA regulated manufacturers must ensure their supply chain of equipment, components, raw materials suppliers, and vendors are in compliance with FDA regulations and guidelines.
- Certify your regulatory submissions are completed and products approved. Face/surgical mask and respirators manufacturers may need FDA 510k approval. Hand sanitizer manufacturers will need drug product approval. Consult with a regulatory consultant to ensure you are in compliance with regulatory requirements.
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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