Chemistry, Manufacturing, and Control (CMC) & Post Approval Regulatory Affairs

Chemistry, Manufacturing, and Control (CMC) & Post Approval Regulatory Affairs; M. Pharmacy -Pharmaceutics; 1st Semester; Regulatory Affairs

1. GURU GOBIND SINGH COLLEGE OF PHARMACY Presented To: Dr. Anjali Sharma Presented By: Prabhjot Kaur (M-507) Chemistry, Manufacturing, and Control (CMC) & Post approval regulatory affairs

2. CONTENT Introduction 1 What is CMC? 2 CMC in regulatory submissions 3 Sections of CMC 4 Conclusion 5

3. Introduction CMC, standing for Chemistry, Manufacturing, and Controls, focuses on the detailed information about the drug substance, manufacturing processes, and quality control measures. The pharmaceutical industry operates within health authorities such as U.S. FDA, EMA, Health Canada, and others. These regulatory agencies use CMC data to assess and ensure the consistency and quality of pharmaceutical products. A CMC (Chemistry, Manufacturing, and Controls) form is typically a comprehensive document or set of documents that pharmaceutical companies submit to regulatory agencies as part of their drug development and approval process.

4. what is CMC CMC (Chemistry, Manufacturing, and Controls): In the context of regulatory affairs, CMC refers to the detailed documentation and data that pharmaceutical companies must provide to regulatory agencies. Chemistry Manufacturing Controls -Detailed characterization of the drug substance. -Includes information on the chemical structure, properties, and specifications of API. -Critical for understanding the fundamental properties of the drug substance. - Processes involved in the production of the drug product. -Involves detailing the manufacturing methods, equipment, facilities, and the entire production workflow. -Ensures that drug is consistently produced with the same quality characteristics. - Quality control measures in place to ensure the consistency and quality. -Includes specifications, analytical methods, and testing procedures to monitor and maintain product quality of each batch.

5. Drug used in clinical studies Safe and effective Drug marketed to consumers Commercial product Manufacturers should maintain the connection in quality between the drug used in clinical studies and the marketed drug

6. CMC in Regulatory Submissions CMC data plays a central role in regulatory submissions, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), post approval changes etc. CMC Benefits Demonstration of Product Understandin g Ensuring Consistency and Reproducibility Quality Control and Assurance Lifecycle Management Technology Transfer and Scale-Up Addressing Regulatory Concerns

7. Sections of CMC The specific requirements may vary based on the regulatory agency and the stage of development. Here is a general breakdown of the main sections often included in a CMC submission: Chemistry (Section I): 1.1 Drug Substance Characterization: Chemical structure Physicochemical properties Reference standards Specifications 1.2 Drug Product Composition: Formulation details Excipients Specifications

8. Sections of CMC Manufacturing (Section II): 2.1 Manufacturing Process: Description of the manufacturing process for the drug substance and product Process controls In-process testing 2.2 Equipment and Facilities: Details on manufacturing equipment Facility design and specifications 2.3 Control of Critical Steps and Intermediates: Critical steps in the manufacturing process Control strategies for intermediates

9. Sections of CMC Controls (Section III): 3.1 Quality Control Tests: Analytical methods Specifications for raw materials, intermediates, and finished products Stability-indicating methods 3.2 Batch Records: Documentation of each batch produced Records of deviations and corrective actions 3.3 Stability Testing: Stability studies to support shelf life and storage conditions Results and conclusions

10. Sections of CMC Regulatory Strategy (Section IV): 4.1 Regulatory Submissions Plan: Overview of the regulatory strategy and timeline Plans for interactions with regulatory agencies 4.2 Compliance with Regulatory Guidelines: Assurance of compliance with applicable regulatory guidelines Responses to relevant regulatory requirements Appendices: Additional supporting documents, such as validation reports, certificates of analysis, and other relevant data. Abbreviations.

11. Conclusion In conclusion, the CMC section ensures not only regulatory compliance but serves as a means of assurance for product quality, safety, and efficacy. As we navigate the dynamic pharmaceutical environment, the adaptability of CMC to evolving standards and its role in continuous improvement underscore its strategic significance. Embracing transparency and effective communication, the CMC section embodies a commitment to excellence, laying the foundation for advancements in pharmaceutical science and, most importantly, the well-being of patients.

12. Post approval Regulatory Affairs ✔ The FDA may require a post-approval study at the time of approval of a Premarket Approval (PMA), Humanitarian Device Exemption (HDE), or product development protocol (PDP) application to help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved drug product of medical device. ✔ A sponsor's failure to comply with any post-approval requirement may be grounds for withdrawing approval i.e. whether the post approval study will be terminated or revised/replaced

13. Post approval Regulatory Affairs The safety surveillance is designed to detect any rare or long-term adverse effects over the much larger population and longer time period. ✔ Harmful effects shown in this trial may result in drug ban or restricted in certain usages.

14. Post approval studies Drug-drug interaction Drug-food interaction Drug- herbal interaction Pharmacoeconomic Expanded efficinency/safety Additional indication Strategies for minimization of adverse effect. Strategies for dose indivisuilization Optimization of surrogate lab test Special populations New formulation

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