Basics to cGMP in Clean Room Facility.ppt
- 1. Basics to c.GMP Basics to c.GMP Dr.Amgad El-Molla Dr.Amgad El-Molla B#1 Production manager B#1 Production manager VACSERA VACSERA
- 3. 3 Conceptual image coding decoding Conceptual image sender receiver
- 4. 4 System and environment System and environment milieu system interaction
- 5. 5 system system 1 7 6 5 6 5 2 3 4 goal Integrated activities
- 7. 7 Process Vs procedure Process Vs procedure
- 8. 8 Manufacturing process Manufacturing process Product Or service machine man material method minutes milieu money measurements
- 9. 9 Logic and basic science Logic and basic science Good inputs Good process Good output
- 10. 10 What is the quality? What is the quality? Is it the goodness? Is it the goodness? Is it Excellency? Is it Excellency? Is it customer satisfaction? Is it customer satisfaction? Is it extended beyond customer expectations? Is it extended beyond customer expectations?
- 11. 11 Quality is …….. Quality is …….. The fitness for its intended use The fitness for its intended use (comply with predetermined (comply with predetermined SPECS). SPECS).
- 12. 12 Why quality? Why quality? To share market. To share market. Testing a sample of finished product does not Testing a sample of finished product does not reflect the state of all batch. reflect the state of all batch. To save expenses of reprocessing , rework or To save expenses of reprocessing , rework or OOS. OOS.
- 13. 13 batch sample Testing a sample of finished product does not reflect Testing a sample of finished product does not reflect the state of all batch. the state of all batch.
- 14. 14 No sampling method can give us No sampling method can give us high level of assurance except high level of assurance except 100% testing 100% testing but this is can not be done for but this is can not be done for destructive tests destructive tests
- 15. 15 Quality is build in the product Quality is build in the product Quality can not be assessed, tested or inspected into the product. It has to be built into it.
- 16. 16 How can we do How can we do that? that?
- 19. 19 Quality assurance Quality assurance The totality of organized arrangements to ensure that the product fit for intended use
- 20. 20 Quality control Quality control Laboratory testing of Laboratory testing of mainly finished product mainly finished product and materials. and materials.
- 21. 21 What is c.GMP ? What is c.GMP ? Current=updated Current=updated Set of rules that give a Set of rules that give a high degree of high degree of assurance that the assurance that the product or service fit product or service fit for its intended use. for its intended use.
- 22. 22 c.GMP c.GMP Is a tool by which QA can Is a tool by which QA can ensure the quality all over the ensure the quality all over the manufacturing process manufacturing process QA c.GMP
- 24. 24 c.GMP topics c.GMP topics 1-material control. 1-material control. 2-facility. 2-facility. 3-equipment. 3-equipment. 4-personele. 4-personele. 5-documentations. 5-documentations. 6-manufacturing process and control. 6-manufacturing process and control. 7-QC testing and batch release. 7-QC testing and batch release. 8-storage and distribution. 8-storage and distribution. 9-complaint and recall. 9-complaint and recall. 10-deviation and corrective action. 10-deviation and corrective action. 11-inspection. 11-inspection. 12-validation. 12-validation. 13-maintenance. 13-maintenance.
- 26. 26 c.GMP regulations c.GMP regulations American (FDA). American (FDA). Canadian. Canadian. European. European. Japanese. Japanese. WHO. WHO. Etc… Etc…
- 27. 27 European union European union ICH ICH Plus Japan and America
- 29. 29 Personnel Personnel Qualified personnel is the real treasure of Qualified personnel is the real treasure of any organization. any organization. Non qualified personnel is the main Non qualified personnel is the main source of headache. Why? source of headache. Why? (err is human) (err is human) (human is main source of variability) (human is main source of variability) (human is the main source of (human is the main source of contamination) contamination)
- 30. 30 Qualified Vs Educated Qualified Vs Educated Qualified means Qualified means educated and trained to educated and trained to specific job. specific job.
- 31. 31 Personnel Personnel 1. 1. Qualification (CV) Qualification (CV) 2. 2. Training (record) Training (record) 3. 3. Health condition (record) Health condition (record) 4. 4. Job specifications (specs) Job specifications (specs) 5. 5. Job description (responsibility) Job description (responsibility) 6. 6. Organigram (management) Organigram (management) 7. 7. Personal hygiene and behavior Personal hygiene and behavior
- 32. 32 Facility Facility Space Space Design Design Piping Piping HVAC HVAC Plumping Plumping Water system Water system Electricity Electricity Traffic and access Traffic and access Containment and segregation Containment and segregation Waste disposal and management Waste disposal and management Clean room design Clean room design
- 33. 33 Philosophy of clean room design Philosophy of clean room design Clean rooms are designed to minimize Clean rooms are designed to minimize 1- intrusion 1- intrusion 2-retention 2-retention 3-genertation 3-genertation Of particles Of particles
- 34. 34 Particle Vs Fiber (lint) Particle Vs Fiber (lint)
- 35. 35 D C B A Clean room design
- 36. 36 Documentation Documentation What is not What is not documented is just documented is just a rumor ! a rumor !
- 37. 37 Why documentation? Why documentation? Traceability. Traceability. Historical based on studies Historical based on studies Legal protection. Legal protection. Compliance with regulation. Compliance with regulation. Find out the Find out the real cause real cause of any deviation. of any deviation. Easily reviewed, revised and authorized Easily reviewed, revised and authorized
- 38. 38 The real cause (root cause) The real cause (root cause) Is usually not the obvious one Is usually not the obvious one
- 39. 39 You must remember that diagnosed You must remember that diagnosed problem is half solved problem is half solved Use always cause and effect diagram Use always cause and effect diagram
- 40. 40 Problem solving Data collection Optimum solution & alternatives Data analysis Implement Check Accepted Not accepted
- 41. 41 Document Vs record Document Vs record
- 42. 42 Types of documents Types of documents 1- 1- Descriptive: Descriptive: C.V C.V SPECS SPECS 2- 2- command and request: command and request: SOPs SOPs Protocols Protocols
- 43. 43 S.O.P. S.O.P. Standard operating procedure Standard operating procedure It is a document that describe the It is a document that describe the process orderly in command process orderly in command voice (do, do not) and makes voice (do, do not) and makes one not asking any question. one not asking any question. ! ? ! ?
- 44. 44 As it is answering all expected As it is answering all expected questions questions Why? -------------------------------------(objectives). Why? -------------------------------------(objectives). When and where? ---------------------------(scope). When and where? ---------------------------(scope). Who? ---------------------------------(responsibility). Who? ---------------------------------(responsibility). How?------------------------------------- (procedure). How?------------------------------------- (procedure). What is next ?-----------------------------(reporting). What is next ?-----------------------------(reporting).
- 45. 45 Compliance Vs conformance Compliance Vs conformance Compliance Conformance Compliance Conformance Non-compliance Non-conformance Non-compliance Non-conformance ( out of specifications ) ( out of specifications ) (OOS) (OOS) with with with with Regulations Specifications Regulations Specifications
- 46. 46 Deviation Deviation Is a term describe any abnormality Is a term describe any abnormality in execution of established and in execution of established and approved SOP. whether it leads to approved SOP. whether it leads to OOS or not. OOS or not. ( OOS is the result of deviation but ( OOS is the result of deviation but not essentially the reverse). not essentially the reverse).
- 47. 47 How deviation is dealt with? How deviation is dealt with? Correction. Correction. (reprocessing & rework) (reprocessing & rework) Corrective action. Corrective action. (prevent future recurrences) (prevent future recurrences) Preventive action. Preventive action. (prevent potential deviation) (prevent potential deviation)
- 49. 49 Monitoring Monitoring Continuous check of Continuous check of process process For early detection. For early detection. Tuning up & adjusting. Tuning up & adjusting. Establishing criteria. Establishing criteria. Controlling the process. Controlling the process.
- 50. 50 Please remember Please remember We can not control: We can not control: What we can not measure (non What we can not measure (non measurable) measurable) Variable (inconsistent) Variable (inconsistent)
- 51. 51 Validation (qualification) Validation (qualification) &verification &verification Validation=establishing a documented, Validation=establishing a documented, objective evidence that objective evidence that The process (V) The process (V) The method (V) The method (V) The system (Q) The system (Q) The equipment (Q) The equipment (Q) The person (Q) The person (Q) Perform as intended for use (predetermined SPECS)
- 52. 52 verification verification Confirmation by examination and Confirmation by examination and provision of objective evidence provision of objective evidence that specified requirements have that specified requirements have been full filled been full filled
- 54. 54 Calibration Vs standardization Calibration Vs standardization
- 55. 55 Now we can summarize Now we can summarize quality quality is is Compliance. Compliance. Conformance. Conformance. Consistency. Consistency. Controlled state. Controlled state.
- 56. General characteristics General characteristics of high quality drug of high quality drug Same as itself (Identity) Same as itself (Identity) Strength (Effective) Strength (Effective) Safe Safe Single (Purity) Single (Purity) Stable Stable Sterile (if recommended Sterile (if recommended) )
- 57. 57 Thanks
- 59. 59 To be in Compliance means To be in Compliance means Coordination (Global Policy & Standards) Coordination (Global Policy & Standards) Cooperation (sharing knowledge & support Cooperation (sharing knowledge & support globally) globally) Capacity (make realistic Plans for big Capacity (make realistic Plans for big changes) changes) Competence (get trained to gain Competence (get trained to gain competence) competence) Consistency (use same measurements & Consistency (use same measurements & tools Globally) tools Globally) Consequences (for those not in compliance) Consequences (for those not in compliance)
Editor's Notes
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