FDA Guidance Overview: The US FDA has recently (December 2023) issued immediate implementation guidance focusing on the reformulation of drug products containing carbomers manufactured with benzene. This guidance prioritizes safety considerations and outlines recommendations for testing, documentation, and submission types to facilitate compliance with cGMP requirements.
Key Recommendations and Requirements The recommendations align with International Council for Harmonization (ICH) guidelines and cover various dosage forms, including semisolid dosage forms, immediate-release and modified-release solid oral dosage forms, and oral suspensions.
Implementation Without Prior Public Comment: Given the urgency of addressing benzene, a known human carcinogen, the FDA has implemented this guidance without prior public comment. The focus is on expediting the discontinuation of using carbomers manufactured with high levels of benzene, utilizing a risk-based approach.
Client Responsibilities: Manufacturers are urged to avoid using benzene in drug manufacturing. The guidance underscores the need for thorough evaluation and submission of proposed changes through either a Changes Being Effected in 30 Days (CBE-30) supplement or a Prior Approval Supplement (PAS), depending on the nature of the change.
Dosage Form-Specific Recommendations: The FDA guidance provides detailed recommendations for various dosage forms, and our consulting team is well-equipped to assist you in implementing these recommendations effectively.
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The experts at MCS associates can support your compliance requirements by working with you on:
1. Strategic Reformulation Planning: MCS experts can provide comprehensive support in developing strategic reformulation plans, ensuring a smooth transition away from benzene-manufactured carbomers.
2. Regulatory Submission Assistance: MCS can assist in preparing and submitting the necessary documentation, whether it be a CBE-30 supplement or a PAS, streamlining the regulatory approval process.
3. Specifications Development: MCS can assist in developing comprehensive finished product and raw material specifications, aligning with industry standards and regulatory requirements for enhanced quality control.
4. Risk Management Strategies: MCS offers a tailored risk assessment approach to evaluate potential effects on drug quality, helping you proactively manage risks and ensure compliance.
5. Communication with Regulatory Authorities: Our team facilitates effective communication with regulatory authorities, helping clarify expectations and address any queries during the reformulation process.
How Our Firm Can Benefit You:
• Expertise: Our team comprises seasoned professionals with in-depth knowledge of pharmaceutical quality and regulatory compliance.
• Custom Solutions: We tailor our services to your specific needs, ensuring that our guidance aligns seamlessly with your business objectives.
• Timely Support: We understand the urgency of regulatory changes and provide timely support to facilitate a swift and compliant transition.
As a part of our core competencies, MCS Associates can help interpret these new guidance documents to determine the impact for clients involved in pharmaceutical and dietary supplement/natural health product production as well as compounding pharmacies. Our comprehensive set of services aim to simplify the reformulation process, enhance specifications development, and ensure your overall compliance with FDA guidance. We are dedicated to supporting your pharmaceutical quality initiatives and ensuring a seamless transition.
To learn more or request testing please contact us at: email@example.com