Enhanced_cGMP_Presentatisdsdsdsdsdsdon.pptx

sdsdsdsds

1. Current Good Manufacturing Practices (cGMP) Presented by: Kwality Pharmaceuticals Ltd. – Unit II, Amritsar

2. What is cGMP? Current Good Manufacturing Practices (cGMP) are regulations enforced by regulatory agencies to ensure pharmaceutical products are consistently produced and controlled according to quality standards. Key Focus: - Creating, implementing, and sustaining a culture of compliance.

3. Regulatory Authorities & Guidelines India: CDSCO - Schedule M (Drug & Cosmetic Act) USA: US FDA - 21 CFR Part 210 & 211 Europe: EMA - EUGMP UK: MHRA - UK Guidelines Australia: TGA - Therapeutic Goods Administration Brazil: ANVISA - National Health Surveillance Agency Canada: Health Canada - GMP Regulations

4. Core Components of cGMP (21 CFR Part 211) - General Provisions - Organization & Personnel - Building & Facilities - Equipment - Control of Components & Drug Product Containers & Closures - Production & Process Control - Packaging & Labeling Control - Holding & Distribution - Laboratory Controls - Records & Reports - Returned & Salvaged Drug Products

5. European GMP Structure 1. Pharmaceutical Quality System 2. Personnel 3. Premises & Equipment 4. Documentation 5. Production 6. Quality Control 7. Outsourcing 8. Complaints & Recalls 9. Self-Inspection 21 Annexes (18 & 20 Removed)

6. Schedule M: Chapters Summary (CDSCO – India) - Premises & Environment - Warehousing - Production - QC Laboratory - Personnel Requirements - Sanitation & Hygiene - Raw Material Handling - Documentation - Quality Assurance - Self-Inspection - Product Recall Systems - Master Formula & Batch Records

7. Quality Definition “Fitness for Purpose” Principle: - Every product must meet established identity, strength, purity, and safety standards. - Quality is the responsibility of everyone in the organization, from management to operators. - Incorporates Safety & Efficacy intrinsically.

8. Quality by Design (QbD) - Define desired product performance and develop processes to consistently achieve it. - Focus on scientifically sound design of processes and products from early development stages.

9. Responsibility for Quality | Stakeholder | Responsibility | |------------|---------------| | Senior Management | Establish & sustain a culture of compliance | | All Employees | Follow defined procedures diligently | | Suppliers | Provide materials of consistent quality | | Distributors | Ensure safe product handling & storage |

10. Importance of GMP - Prevent Toxic Contamination - Ensure Correct Active Ingredient Amounts - Avoid Defective Product Distribution - Protect Patients and Maintain Brand Trust

11. Objectives of cGMP - Understand Quality Assurance (QA) & Quality Control (QC) Systems - Comply with Regulatory Framework - Apply Consistent Documentation and Monitoring - Conduct Continuous Process Improvement

12. Basic GMP Elements - Personnel Training & Responsibility - Proper Premises and Equipment - Sanitation & Hygiene Practices - Accurate Documentation - Internal Audits - Storage & Distribution - Product Recall Mechanism

13. Quality Unit Roles | Function | Responsibility | |----------|---------------| | QA | Procedure Review, Documentation, Trend Analysis | | QC | Sampling, Testing, Specification Compliance, Batch Release |

14. Quality Systems Model 1. Management Responsibilities 2. Resource Provisioning 3. Controlled Manufacturing Operations 4. Evaluation Activities (Internal Audits, CAPA, Continuous Improvement)

15. Fifteen GMP Rules - Written Instructions - Accurate Personnel Actions - Correct Equipment Usage - Prevent Cross-contamination - Avoid Labeling Errors - Maintain Clean Environment - Accurate Record-Keeping - CAPA Implementation - Validate Processes

16. Processing Requirements - Clear Process Definitions & Validation - Change Control System - Proper Documentation - Batch Traceability - Quarantine & Release Protocols - Discrepancy Investigations

17. QC Requirements - Validated Sampling Methods - Calibrated Testing Equipment - Proper Storage of Samples - Compliance with Specifications - Batch Release by QC Department Only

18. Process Validation Lifecycle 1. Process Design 2. Process Qualification 3. Continued Process Verification

19. Equipment Qualification Phases - Design Qualification (DQ) - Installation Qualification (IQ) - Operational Qualification (OQ) - Performance Qualification (PQ) All documented in a Validation Master Plan.

20. Good Documentation Practices (GDP) - Structured Documentation Hierarchy - Clear, Legible, Contemporaneous Entries - Strict Change Control - Proper Record Retention - ALCOA+ Principles

21. Deviation & Change Control Process - Initiation, Evaluation, Approval, Implementation, Monitoring - Critical, Major, Minor categories - Involve all stakeholders from originator to QA reviewer

22. Risk Assessment in GMP - Use of HACCP, FMEA, HAZOP - Scientifically-based evaluations - Apply appropriate risk controls and monitor effectiveness

23. CAPA System Overview - Corrective Actions - Root Cause Analysis - Preventive Measures - Documentation of all steps

24. Ten GMP Commandments - Clean workspace & equipment - Follow SOPs and validated procedures - Accurate signatures & records - Promptly report deviations

25. Storage Requirements - Maintain Clean & Organized Areas - Apply FIFO/FEFO Principles - Monitor Environmental Conditions (Temp, RH) - Properly segregate Quarantine, Hazardous Materials

26. Product Complaint & Recall Systems - Designated Responsible Person - Complaint Investigation - CAPA Implementation - Regulatory Reporting - Recall Coordination & Reconciliation

27. Conclusion “In the race for Quality, there is no finish line.” Commitment to continuous improvement is essential.

28. Thank You Kwality Pharmaceuticals Ltd. – Unit II, Amritsar [Contact Information]