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MavericKR believes that Today’s Young minds are Tomorrow’s future. We therefore provide facilities of Training and expertising industries as well as studentsaccording to their needs. Our training programs includes:
| S. No. | Module | Scope |
|---|---|---|
| 1 | Part 1. GMP Overview | 1. Introduction 2. Quality Management 3. Sanitation and hygiene 4. Qualification and Validation 5. Complaints and recalls 6. Contract production and analysis 7. Self Inspection and quality audits 8. Personnel 9. Premises 10. Equipment 11. Materials 12. Documentation 13. Good Practices in production and quality control 14. Sterile production 15. Active pharmaceutical ingredients |
| Module | Scope | |
|---|---|---|
| Part 2. GMP Inspection Process | 1. Introduction 2. Quality Management 3. Sanitation and hygiene 4. Qualification and Validation 5. Complaints and recalls 6. Contract production and analysis 7. Self Inspection and quality audits 8. Personnel 9. Premises 10. Equipment 11. Materials 12. Documentation 13. Good Practices in production and quality control 14. Sterile production 15. Active pharmaceutical ingredients 1. Introduction a. Guidelines b. Production and control c. Final dosage forms d. Dug substances e. Fundamental principles f. Inspection and licensing g. Inspectorate h. Functions i. Objectives 2. The role of the inspector a. Objectives b. Qualifications c. Training d. Responsibilities e. Personal Qualities f. Communication Skills g. Group Session h. Possible Situations 3. Preparation for the inspection a. To discuss the process of conducting an inspection b. To review a number of inspection techniques c. To discuss issues you may encounter when performing an inspection d. Checklists e. Flowcharts/process charts f. Standard for all full inspections g. Use in preparation stage h. Preparation for the exit meeting i. Preparation of the report j. Taking Samples 4. The inspection process 5. Types of GMP inspection 6. Trainers’ notes |
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| Module | Scope | |
|---|---|---|
| Part 3. GMP for Active Pharmaceutical Ingredients | 1. GMP guideline 2. Quality Management a. Change control b. Complaints and recalls c. Rejection and re-use of material 3. Personnel 4. Buildings and facilities 5. Equipment and materials 6. Documentation 7. Production and storage 8. Validation 9. Laboratory control 10. Stability testing 11. Contract manufacturing and testing | |
| Module | Scope | |
|---|---|---|
| Part 4. Qualification and Validation | 1. Principle 2. Scope a. Documented evidence (DQ, IQ) • Premises • Supporting utilities • Equipment b. Documented evidence (OQ, PQ) • Supporting utilities • Equipment c. Process Validation (PV) d. Qualification and validation of premises, facilities (utilities), equipment, processes. e. Re-qualification or re-validation in case of Significant change. f. Types of Documentation • Validation Master Plan (VMP) • Validation protocols • Validation reports • Standard Operating Procedures (SOPs) g. Validation of: • Analytical test methods • Automated systems • Cleaning procedures h. Risk assessment c • Identifying the need for qualification, or the extent and or scope of qualification (e.g. utilities and equipment) • Areas of focus in process validation • Cleaning validation | |
| Module | Scope | |
|---|---|---|
| Part 5. General overview on qualification and validation | a. Validation as an essential part of GMP and an element of QA b. Basic principles : ● Safety, quality and efficacy of products ● Built into the product – as it cannot be "inspected or tested into a product" ● Critical steps in the process need to be validated c. Need for confidence that the product will consistently meet predetermined specifications and attributes d. Documentation associated with validation e. Resources for validation f. Scope of validation g. Qualification h. Approaches to validation i. Calibration and verification j. Traceability k. Qualification and validation protocols l. Qualification and validation reports m. Qualification stages ● Design qualification (DQ); ● Installation qualification (IQ); ● Operational qualification (OQ); and ● Performance qualification (PQ). n. Requalification o. Revalidation ● Periodic revalidation | |
| Module | Scope | |
|---|---|---|
| Part 6. Qualification of HVAC | a. Objectives i. commissioning, ii. qualification and iii. maintenance of HVAC b. Documentation requirements c. DQ – Design of the system, URS (e.g. components, type of air treatment needed, materials of construction) c. IQ – Verify installation i. E.g. relevant components, ducting, filters, controls, monitors, sensors, etc. d. Schedule of tests to demonstrate continuing compliance e. Recommended optional strategic tests f. Cleanroom monitoring programme g. Qualification – examples of aspects to consider in qualification (OQ, PQ) h. Maintenance i. Inspecting the air-handling system j. Group Discussions | |
| Module | Scope | |
|---|---|---|
| Part 7 Heating, Ventilation and Air - Conditioning (HVAC) Commissioning, qualification and maintenance |
1. Documentation requirements to assist in commissioning, qualification and maintenance 2. Schedule of tests to demonstrate continuing compliance 3. Strategic tests 4. Clean room monitoring program a. Particles and b. Microbiological contaminants 5. Inspecting the air-handling system | |
| Module | Scope | |
|---|---|---|
| Part 8. Cleaning validation |
1. Objectives 2. Principles and approaches to cleaning validation including: i. Protocols and reports ii. Personnel and equipment iii. Use of detergents iv. Microbiology v. Sampling vi. Analytical methods and vii. Acceptable limits 3. Scope 4. SOPs for cleaning processes 5. Cleaning policy and cleaning validation procedure 6. Data on recovery studies 7. Analytical methods 8. Acceptance criteria 9. Cleaning agent 10. Revalidation requirements 11. Critical areas for sampling? Microbiological contamination | |
| Module | Scope | |
|---|---|---|
| Part 9. Analytical method validation |
1. Principles of analytical method validation 2. Pharmacopoeia methods 3. Non-pharmacopoeia methods 4. Approaches to analytical method validation 5. Characteristics of analytical procedures • specificity • linearity • range • accuracy • precision • detectionlimit • quantitationlimit • robustness 6. System suitability testing | |
| Module | Scope | |
|---|---|---|
| Part 10. Computerized system validation |
1. System specifications 2. Functional specifications 3. Security 4. Back-ups 5. Validation: 6. Hardware 7. Software 8. System specification (Control document) | |
| Module | Scope | |
|---|---|---|
| Part 11. Qualification of systems and equipment |
1. Principles of qualification of systems and equipment. 2. The different stages of qualification a. Requalification and b. Qualification of “in use” systems and equipment 3. All stages of qualification applicable (DQ, IQ, OQ and PQ) | |
| Module | Scope | |
|---|---|---|
| Part 12. Process Validation |
1. General recommendations 2. Prospective validation 3. Concurrent validation 4. Retrospective validation 5. Revalidation 6. Change control | |
| Module | Scope | |
|---|---|---|
| Part 13. GMP for Sterile product process validation |
1. Methods of sterilization including a. Terminal sterilization i. Moist heat ii. Dry heat iii. Radiation iv. Gas and fumigants b. Aseptic processing by filtration 2. Bioburden 3. Minimal microbial contamination of starting materials 4. Suitability for the product 5. Efficacy 6. Biological indicators 7. Isolatortechnology 8. Validated loading patterns 9. Validation of the sterilization cycle (terminally sterilized products) 10. Media simulation or media fill runs (aseptically processed) | |
| Module | Scope | |
|---|---|---|
| Part 14. Water for Pharmaceutical Use |
1. Qualification a. OQ: operational qualification b. Presentation focusing on PQ c. PQ demonstrates consistent and reliable performance of the system d. Three phase approach recommended over extended period – proves reliability and robustness 2. Sample Plan for Phase 1, 2, 3 3. Ongoing system monitoring 4. Maintenance 5. System review : WPU (PW, HPW and WFI) a. changes made since the last review; b. system performance; c. reliability; d. quality trends; e. failure events; f. investigations; g. out-of-specifications results from monitoring; h. changes to the installation; i. updated installation documentation; j. log books; and k. the status of the current SOP list | |
| Module | Scope | |
|---|---|---|
| Part 15. Water for Pharmaceutical Use Water purification, storage and distribution |
1. Water purification systems 2. Storage and distribution requirements 3. Sanitization 4. Factors influencing the quality of water 5. Location of the plant room; temperatures 6. Leachates and adsorptive contact materials 7. Hygienic or sanitary design 8. Corrosion; leakage 9. Proliferation of microbiological organisms, cleaning; sanitizing 10. Capacity and output requirements 11. Instruments, test and sampling points 12. Pre-treatment steps 13. Production of drinking water 14. Production of Purified Water (PW) 15. Production of Highly Purified Water (HPW) 16. Production of Water for Injections (WFI) 17. Water storage and distribution systems 18. Contact materials 19. System sanitization and bioburden control 20. Storage Vessel 21. water distribution pipework 22. Biocontamination control | |
| Module | Scope | |
|---|---|---|
| Part 16. Inspection of water purification systems |
1. Schematic drawing review 2. Changes to system since installation 3. Sampling procedure and plan 4. Specifications, results and trends 5. Out-of-specification results 6. Annual system review 7. Deviations 8. Results of system performance monitoring 9. Out of limit results, failure investigations and alarms recorded 10. Sanitization procedures and records 11. Maintenance and repairs logs/records 12. Instrument calibration and standardization 13. Qualification and validation including DQ, IQ, OQ, PQ 14. Requalification when appropriate, etc. 15. On site review and verification for raw water 16. On site review and verification (e.g. PW): 17. Water treatment system inspection. a. dead legs b. filters c. pipes and fittings d. Ionic beds e. storage tanks f. by-pass lines a. pumps b. UV lights c. sample points d. reverse osmosis e. valves f. heat exchangers g. Instruments, controls, gauges, etc. a. Material of construction b. Weld quality c. Hygienic couplings d. Passivation procedure and records e. Air breaks or “Tundish” f. Pipes and pumps g. condition of equipment 18. Maintenance records of all critical parts 19. Documentation review 20. Sampling 21. Testing 22. Trend of bacterial limits (CFU/mL) 23. Pyrogens and endotoxins | |
| Module | Scope | |
|---|---|---|
| Part 17. Quality Management |
1. Key issues in quality assurance/good manufacturing practices/quality control. 2. Specific requirements on quality management and quality assurance including: a. Organization b. Procedures, processes and resources. 3. To develop actions to resolve current problems. 4. Philosophy and essential elements 5. Quality Management 6. Principles of Quality Assurance (QA) 7. Fault Tree Analysis (FTA) 8. Hazard and Operational Studies (HAZOP) 9. Failure Mode and Effect Analysis (FMEA) 10. Hazard Analysis and Criticality Analysis (HACCP) 11. Failure Mode, Effect, and Criticality Analysis (FMECA) | |
| Module | Scope | |
|---|---|---|
| Part 18. Validation Master Plan; Protocols and reports |
1. Key elements of the validation programme. 2. Validation policy 3. Organizational structure of validation activities 4. Summary of facilities, systems, equipment and processes validated (and to be validated) 5. Documentation format (e.g. protocol and report) 6. Planning and scheduling 7. Change control and references to existing documents | |
| Module | Scope | |
|---|---|---|
| Part 19. Calibration and change control |
1. Importance 2. Impact of change 3. Effective procedure to address | |
| Module | Scope | |
|---|---|---|
| Part 20 Data Integrity |
1. Introduction 2. Scope 3. Data integrity verification methods 4. Classification as of deviations | |
| Module | Scope | |
|---|---|---|
| Part 21. Good Laboratory Practices |
1. Management and infrastructure: 2. Ideal Layout and manpower 3. Responsibilities 4. Quality manual 5. Personnel matters, including qualifications, training, clothing and hygiene 6. Premises 7. Equipments 8. Contract 9. Sub-contract 10. Change control; internal audits 11. Dealing with complaints 12. Corrective and preventive actions 13. Purchase and receipt of materials (e.g. samples, reagents) 14. SOPs 15. Control of documents 16. Sampling procedure and sampling plan 17. Representative of the batch (statistics?) 18. Records 19. Registration and labelingv 20. Procedure of visual inspection and storage of the submitted sample 21. Reagents 22. Volumetric solutions: 23. Storage of reagents 24. Reference substances and reference materials 25. Procedure for forwarding to testing / work allocation 26. Retesting (monitoring) 27. Analytical worksheet 28. Specifications 29. Filing / archiving 30. Validation of analytical procedures 31. System suitability testing 32. Calibration, validation and verification of equipment, instruments and other devices 33. Testing 34. Evaluation of test results 35. Certificate of analysis 36. Traceability 37. Validation of Software 38. Back up (intervals, retrievable, storage, no data loss). 39. Retained samples 40. Safety | |