Whether building a new facility (greenfield) or upgrading a facility (brownfield), it is important to understand the regulations governing facilities and inspection readiness. The Code of Federal Regulations Part 211 governs the United States, Eudralex Volume 4 governs the European Union, and the Ministry of Health, Labour, and Welfare govern Japan. Knowing the facility requirements for these regions is important information needed to assist your decision on whether it is more feasible and economical to build a new facility or upgrade an existing facility. Whatever decision you decide to make, Regulatory Compliance Associates Inc. can help you achieve a successful outcome.
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The pharmaceutical industry has been trying to become more efficient from both manufacturing and regulatory perspectives. The challenge is to improve processes, quality systems, and manufacturing capabilities while operating efficiently and in a manner that ensures safe, effective, and cost-efficient medicines to patients. Many process updates and quality system updates can be easily and readily implemented with little or no impact on regulatory filings. When a change impacts regulatory filings, it has the potential to disrupt the supply chain if it is not handled appropriately and as efficiently as possible. FDA seems to recognize these situations and has been working to help lessen the regulatory filing burden to companies while not affecting the quality of the products.
If you are a contract manufacturer the first step in the process of upgrading your facility is to get the agreement, or at least, an acknowledgment from your clients that they are aware that you intend to upgrade the facility and that it may affect their regulatory filing. Both you and your client(s) may have responsibilities outlined in the quality agreement regarding maintaining and upgrading the facility and the decision to upgrade an existing facility should be made with the knowledge and input of your client(s). Using a comparability protocol is a great way to communicate your intended upgrades to your client. Employing the use of a comparability protocol you are, in essence, making sure your client understands the change you will be implementing and the data you will be collecting and reviewing to assess that the upgrade was successful and did not affect product quality. The comparability protocol is a nice compromise when you are dealing with multiple clients who have different regulatory filing strategies.
The best way to upgrade a facility in a timely manner is to make sure you have a robust quality agreement in place that gives you the responsibility for maintaining your facility, become familiar with the regulations and use them to justify your recommendation, and finally, use a comparability protocol for proving like-to-like equivalency. These steps should help you implement a facility upgrade in a timely manner while reducing your downtime to make the improvement.
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