Navigating the new Modernization of Cosmetics Regulation Act of 2022 (MoCRA) can be overwhelming. At cGMP Consulting, we bring over 23 years of regulatory and compliance experience to guide you through these changes.

MoCRA brings major updates to the US cosmetic industry. Understanding these new requirements is crucial for ensuring your products meet regulatory standards. Here’s a breakdown of MoCRA’s key requirements and how we can help you stay compliant and competitive.

1. Facility Registration

You must register your facility with the FDA. This step ensures that your manufacturing operations are officially recognized and monitored.

2. Product Registration

You must list all cosmetic products and their ingredients with the FDA. This step ensures transparency and safety for consumers.

3. Safety Substantiation

Before marketing, you must provide evidence that your products are safe for use. This involves conducting necessary tests and reviews to substantiate product safety. Maintain detailed records to support product safety and regulatory compliance. MoCRA gives the FDA new authorities to access and copy certain records, including safety records. Proper documentation ensures you can quickly address any issues that arise.

4. Labeling

Ensure your products have clear and accurate labels listing the Responsible Person, all ingredients, potential allergens, and professional use instructions. This transparency is essential for consumer safety and regulatory compliance.

5. Adverse Event Reporting

Implement systems to monitor and report any adverse events related to your products. This step is crucial for maintaining consumer trust and regulatory compliance.

6. Good Manufacturing Practices (GMP)

MoCRA mandates adherence to updated GMPs specific to the cosmetics industry. These practices are designed to safeguard product quality and consumer health.

GMPs ensure that companies consistently produce and control products according to quality standards. They encompass everything from raw materials and equipment controls to staff training and hygiene, preventing contamination and errors. Here are the nine key components of cosmetic GMPs:

• Quality Management: Implement a system to manage quality at every production stage.

• Documentation: Keep detailed records of manufacturing and testing procedures.

• Records: Maintain logs of operations, procedures, deviations, specifications, protocols, reports, corrective actions, training, and batch production.

• Buildings & Facilities: Keep sufficiently sized facilities clean, well-maintained, environment and pest controlled.

• Equipment: Clean, calibrate, and maintain equipment regularly.

• Personnel: Ensure staff cleanliness and adherence to policies.

• Raw Materials & Packaging: Store and label materials to prevent mistakes and contamination

• Production: Establish SOPs for formulations, processing, and equipment operation.

• Laboratory Controls: Implement precise testing methods and maintain equipment.

• Internal Audit: Procedures for audits to occur regularly and on demand.

• Complaints, Adverse Events, and Recall: Respond effectively to consumer complaints with a process to report to the FDA.

How cGMP Consulting Can Help

With our extensive experience, we offer expert guidance and support to help you meet these new requirements. Here’s how we can assist:

• Regulatory Submissions and Liaison: We help with registering your facility, products, and ingredients with the FDA and manage communications with regulatory authorities, addressing any compliance issues that arise.

• Documentation and Record Keeping: We help develop and maintain the necessary documentation to support compliance with MoCRA, ensuring that records are organized and accessible.

• Product Safety and Quality Assurance: We assist in substantiating the safety of your products through tests and reviews. Our experts establish quality assurance protocols to monitor and enhance product safety.

• Regulatory Compliance Assessment: We conduct thorough assessments of your operations to identify compliance gaps with MoCRA and GMP requirements. We provide detailed reports and actionable plans to address these gaps.

• GMP Implementation and Training: Our consultants assist in implementing robust GMP systems tailored to your needs and offer comprehensive training programs to ensure your staff is knowledgeable about GMP practices.

Why Choose cGMP Consulting?

With over 23 years of experience, we are a reliable partner in navigating complex regulations. We provide customized solutions that address your specific needs and challenges. The benefits of partnering with us are:

• Expertise: Our consultants stay current with regulatory changes and industry best practices.

• Tailored Solutions: We offer services customized to your business needs.

• Proactive Approach: We help you stay ahead of regulatory changes, minimizing disruptions.

• Peace of Mind: Focus on your core business activities while we handle your regulatory compliance. We will carry the load, driving the completion of the project, thereby minimizing the burden of limited time and resources.

Conclusion

MoCRA introduces significant changes to the cosmetics industry. Staying compliant is crucial for your business’s success. Partner with cGMP Consulting to ensure you meet these new requirements efficiently. Our expertise and support will help you maintain the highest standards of product safety and quality.

cGMP Consulting will take good care of your business when dealing with MoCRA. We tailor our solutions to meet your specific needs, enabling you to focus on your strengths. We will handle all regulatory compliance tasks for you. Our proactive approach helps you stay ahead of regulatory changes, allowing for smooth business operations and peace of mind.

Don’t let MoCRA regulations overwhelm you. Contact us today to discover how cGMP Consulting can assist with MoCRA compliance and enhance your business’s success in a dynamic regulatory landscape.

Reach out now at https://cgmpconsulting.com/contact-us/ for a free consultation and let us guide you through MoCRA compliance with ease.