GMP and cGMP


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GMP and cGMP

  2. 2. 03/22/1503/22/15 What is GMP ?What is GMP ?  GMP is that part of Quality assuranceGMP is that part of Quality assurance which ensures that the products arewhich ensures that the products are consistently manufactured and controlledconsistently manufactured and controlled to the Quality standards appropriate toto the Quality standards appropriate to their intended usetheir intended use  "GMP""GMP" - A set of principles and procedures- A set of principles and procedures which, when followed by manufacturerswhich, when followed by manufacturers for therapeutic goods, helps ensure thatfor therapeutic goods, helps ensure that the products manufactured will have thethe products manufactured will have the required quality.required quality.
  3. 3. 03/22/1503/22/15 What is cGMP ?What is cGMP ?  Usually see “cGMP” – where c =Usually see “cGMP” – where c = current, to emphasize that thecurrent, to emphasize that the expectations are dynamicexpectations are dynamic
  4. 4. 03/22/1503/22/15 Quality DefinitionQuality Definition  Quality of a medicinal product isQuality of a medicinal product is measured by it’s fitness for purpose .measured by it’s fitness for purpose . Safety and efficacy are not separableSafety and efficacy are not separable from Quality but part of itfrom Quality but part of it  Quality Safety Efficacy XQuality Safety Efficacy X QualityQuality Safety EfficacySafety Efficacy
  5. 5. 03/22/1503/22/15
  6. 6. 03/22/1503/22/15 Good Manufacturing PracticesGood Manufacturing Practices  A basic tenet of GMP is that quality cannotA basic tenet of GMP is that quality cannot be tested into a batch of product but mustbe tested into a batch of product but must be built into each batch of product duringbe built into each batch of product during all stages of the manufacturing process.all stages of the manufacturing process.  It is designed to minimize the risksIt is designed to minimize the risks involved in any pharmaceutical productioninvolved in any pharmaceutical production that cannot be eliminated through testingthat cannot be eliminated through testing the final product.the final product.
  7. 7. 03/22/1503/22/15 Some of the main risks areSome of the main risks are – unexpected contamination of products, causingunexpected contamination of products, causing damage to health or even death.damage to health or even death. – incorrect labels on containers, which couldincorrect labels on containers, which could mean that patients receive the wrongmean that patients receive the wrong medicine.medicine. – insufficient or too much active ingredient,insufficient or too much active ingredient, resulting in ineffective treatment or adverseresulting in ineffective treatment or adverse effects.effects.
  8. 8. 03/22/1503/22/15 Why GMP is importantWhy GMP is important – A poor quality medicine may containA poor quality medicine may contain toxic substances that have beentoxic substances that have been unintentionally added.unintentionally added. – A medicine that contains little or none ofA medicine that contains little or none of the claimed ingredient will not have thethe claimed ingredient will not have the intended therapeutic effect.intended therapeutic effect.
  9. 9. 03/22/1503/22/15 GMP helps boost pharmaceuticalGMP helps boost pharmaceutical export opportunitiesexport opportunities  Most countries will only accept importMost countries will only accept import and sale of medicines that have beenand sale of medicines that have been manufactured to internationallymanufactured to internationally recognized GMP.recognized GMP.  Governments seeking to promote theirGovernments seeking to promote their countries export of pharmaceuticalscountries export of pharmaceuticals can do so by making GMP mandatorycan do so by making GMP mandatory for all pharmaceutical production andfor all pharmaceutical production and by training their inspectors in GMPby training their inspectors in GMP requirements.requirements.
  10. 10. 03/22/1503/22/15 GMP Covers…GMP Covers…  ALLALL aspects of production; from the startingaspects of production; from the starting materials, premises and equipment to thematerials, premises and equipment to the training and personal hygiene of and personal hygiene of staff.  Detailed, written procedures are essential forDetailed, written procedures are essential for each process that could affect the quality of theeach process that could affect the quality of the finished product.finished product.  There must be systems to provide documentedThere must be systems to provide documented proof that correct procedures are consistentlyproof that correct procedures are consistently followed at each step in the manufacturingfollowed at each step in the manufacturing process - every time a product is made.process - every time a product is made.
  11. 11. 03/22/1503/22/15 GMPGMP  The Quality of a formulation or aThe Quality of a formulation or a bulk drug depends on the Quality ofbulk drug depends on the Quality of thosethose producing itproducing it  GMP is the magic key that opens theGMP is the magic key that opens the door of the Qualitydoor of the Quality  In matter of GMP, swim with theIn matter of GMP, swim with the current and in matter of Qualitycurrent and in matter of Quality stand like a rock!stand like a rock!
  12. 12. 03/22/1503/22/15 QA, GMP & QC inter-relationship QC GMP QA
  13. 13. 03/22/1503/22/15 QA, GMP & QC inter-relationship It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use QA
  14. 14. 03/22/1503/22/15 QA, GMP & QC inter-relationship Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use GMP
  15. 15. 03/22/1503/22/15 QA, GMP & QC inter-relationship Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality QC
  16. 16. 03/22/1503/22/15 QC and QAQC and QA  QC is that part of GMPQC is that part of GMP which is concerned withwhich is concerned with sampling,sampling, specifications, testingspecifications, testing and with in theand with in the organization,organization, documentation,anddocumentation,and release proceduresrelease procedures which ensure that thewhich ensure that the necessary and relevantnecessary and relevant tests are carried outtests are carried out  QA is the sum totalQA is the sum total of organizedof organized arrangementsarrangements made with themade with the object of ensuringobject of ensuring that product will bethat product will be of the Qualityof the Quality required by theirrequired by their intended use.intended use.
  17. 17. 03/22/1503/22/15 QC and QAQC and QA  OperationalOperational laboratorylaboratory techniques andtechniques and activities used toactivities used to fulfill thefulfill the requirement ofrequirement of QualityQuality  All those plannedAll those planned or systematicor systematic actions necessaryactions necessary to provideto provide adequateadequate confidence that aconfidence that a product will satisfyproduct will satisfy the requirementsthe requirements for qualityfor quality
  18. 18. 03/22/1503/22/15 QC and QAQC and QA  QC is lab basedQC is lab based  QA is companyQA is company basedbased
  19. 19. 03/22/1503/22/15 GMP guidelinesGMP guidelines  GMP as per Schedule “M”GMP as per Schedule “M”  GMP as per WHOGMP as per WHO  GMP as per MCA now known as MHRAGMP as per MCA now known as MHRA  GMP as per TGAGMP as per TGA  GMP as per US FDAGMP as per US FDA  GMP as per ICH guidelinesGMP as per ICH guidelines
  20. 20. 03/22/1503/22/15 GMPGMP  GMP in solid dosage formsGMP in solid dosage forms  GMP in semisolid dosage formsGMP in semisolid dosage forms  GMP in Liquid oralsGMP in Liquid orals  GMP in Parenterals ProductionGMP in Parenterals Production  GMP in Ayurvedic medicinesGMP in Ayurvedic medicines  GMP in Bio technological productsGMP in Bio technological products  GMP in Nutraceuticals and cosmeceuticalsGMP in Nutraceuticals and cosmeceuticals  GMP in Homeopathic medicinesGMP in Homeopathic medicines
  21. 21. 03/22/1503/22/15 GMPGMP  Good Manufacturing PracticeGood Manufacturing Practice  Good Management PracticeGood Management Practice  Get More ProfitGet More Profit  Give more ProductionGive more Production  GMP Training with out tearsGMP Training with out tears
  22. 22. 03/22/1503/22/15 GMPGMP  All past GMPs are history….It isAll past GMPs are history….It is looking like in rear view mirror andlooking like in rear view mirror and drivingdriving
  23. 23. 03/22/1503/22/15 Ten Principles of GMPTen Principles of GMP 1.1. Design and construct the facilities andDesign and construct the facilities and equipments properlyequipments properly 2.2. Follow written procedures and InstructionsFollow written procedures and Instructions 3.3. Document workDocument work 4.4. Validate workValidate work 5.5. Monitor facilities and equipmentMonitor facilities and equipment 6.6. Write step by step operating procedures andWrite step by step operating procedures and work on instructionswork on instructions 7.7. Design ,develop and demonstrate jobDesign ,develop and demonstrate job competencecompetence 8.8. Protect against contaminationProtect against contamination 9.9. Control components and product relatedControl components and product related processesprocesses 10.10. Conduct planned and periodic auditsConduct planned and periodic audits
  24. 24. 03/22/1503/22/15 Beyond GMPBeyond GMP  Reduce pollution -Reduce pollution - Zero dischargeZero discharge  Adaptation of environment friendlyAdaptation of environment friendly methodsmethods  Consideration for better andConsideration for better and healthier life tomorrowhealthier life tomorrow  Consideration of ethics in lifeConsideration of ethics in life  One should begin with end in mindOne should begin with end in mind otherwise it will be the beginning ofotherwise it will be the beginning of the endthe end
  25. 25. 03/22/1503/22/15 Cost of effective GMPCost of effective GMP  In fact Cost benefits – positive costIn fact Cost benefits – positive cost benefits of GMP/QAbenefits of GMP/QA  Good plant lay out, Smooth work flows,Good plant lay out, Smooth work flows, Efficient documentation systems, wellEfficient documentation systems, well controlled process, good stores lay outscontrolled process, good stores lay outs and stores records- These are Goodand stores records- These are Good manufacturing practicesmanufacturing practices  Reduction in work in process andReduction in work in process and inventory holding costsinventory holding costs  Avoidance of cost of Quality failure ( costAvoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumerof waste, of rework, of recall, of consumer compensation and of loss of companycompensation and of loss of company reputation)reputation)
  26. 26. 03/22/1503/22/15 List of important documents in GMPList of important documents in GMP  PoliciesPolicies  SOPSOP  SpecificationsSpecifications  MFR (Master Formula Record)MFR (Master Formula Record)  BMRBMR  ManualsManuals  Master plans/ filesMaster plans/ files  Validation protocolsValidation protocols  Forms and FormatsForms and Formats  RecordsRecords
  27. 27. 03/22/1503/22/15 10 attributes of a good document10 attributes of a good document 1.1. AccurateAccurate 2.2. ClearClear 3.3. CompleteComplete 4.4. ConsistentConsistent 5.5. IndelibleIndelible 6.6. LegibleLegible 7.7. TimelyTimely 8.8. DirectDirect 9.9. AuthenticAuthentic 10.10. AuthorizedAuthorized
  28. 28. 03/22/1503/22/15 Certifying agenciesCertifying agencies  ICH.ICH.  WHO.WHO.  US FDA.US FDA.  EU/EMEA.EU/EMEA.
  29. 29. 03/22/1503/22/15 How do GMPs of different countriesHow do GMPs of different countries compare?compare? At a high level, GMPs of various nations are veryAt a high level, GMPs of various nations are very similar; most require things like:similar; most require things like:  Equipment and facilities being properlyEquipment and facilities being properly designed, maintained, and cleaneddesigned, maintained, and cleaned  Standard Operating Procedures (SOPs) beStandard Operating Procedures (SOPs) be written and approvedwritten and approved  An independent Quality unit (like QualityAn independent Quality unit (like Quality Control and/or Quality Assurance)Control and/or Quality Assurance)  Well trained personnel and managementWell trained personnel and management
  30. 30. 03/22/1503/22/15 cGMP For Finished PharmaceuticalscGMP For Finished Pharmaceuticals 1.1. General ProvisionGeneral Provision 2.2. Organization & PersonnelOrganization & Personnel 3.3. Building & FacilitiesBuilding & Facilities 4.4. EquipmentEquipment 5.5. Control of Components & DrugControl of Components & Drug Product Containers & ClosuresProduct Containers & Closures 6.6. Production & Process ControlProduction & Process Control 7.7. Packaging & Labeling ControlPackaging & Labeling Control 8.8. Handling & DistributionHandling & Distribution 9.9. Laboratory ControlLaboratory Control 10.10. Records & ReportsRecords & Reports 11.11. Returned & Salvaged DrugsReturned & Salvaged Drugs
  31. 31. 03/22/1503/22/15 General ProvisionGeneral Provision 1.1. ScopeScope 2.2. DefinitionsDefinitions
  32. 32. 03/22/1503/22/15 Organization & PersonnelOrganization & Personnel 1.1. Responsibilities of quality controlResponsibilities of quality control unit.unit. 2.2. Personnel qualifications.Personnel qualifications. 3.3. Personnel responsibilitiesPersonnel responsibilities.. 4.4. Consultants.Consultants.
  33. 33. 03/22/1503/22/15 Building & FacilitiesBuilding & Facilities 1.1. Design and construction features.Design and construction features. 2.2. Lighting.Lighting. 3.3. Ventilation, air filtration, air heatingVentilation, air filtration, air heating and cooling.and cooling. 4.4. Plumbing.Plumbing. 5.5. Sewage and refuse.Sewage and refuse. 6.6. Washing and toilet facilities.Washing and toilet facilities. 7.7. Sanitation.Sanitation. 8.8. MaintenanceMaintenance..
  34. 34. 03/22/1503/22/15 EquipmentEquipment 1.1. Equipment design, size, andEquipment design, size, and location.location. 2.2. Equipment construction.Equipment construction. 3.3. Equipment cleaning andEquipment cleaning and maintenance.maintenance. 4.4. Automatic, mechanical, andAutomatic, mechanical, and electronic equipment.electronic equipment. 5.5. Filters.Filters.
  35. 35. 03/22/1503/22/15 Control of Components & DrugControl of Components & Drug Product Containers & ClosuresProduct Containers & Closures 1.1. General requirements.General requirements. 2.2. Receipt & storage of untested components,Receipt & storage of untested components, drug product containers, and closures.drug product containers, and closures. 3.3. Testing and approval or rejection ofTesting and approval or rejection of components, drug product containers, andcomponents, drug product containers, and closures.closures. 4.4. Use of approved components, drug productUse of approved components, drug product containers, and closures.containers, and closures. 5.5. Retesting of approved components, drugRetesting of approved components, drug product containers, and closures.product containers, and closures. 6.6. Rejected components, drug product containers,Rejected components, drug product containers, and closures.and closures. 7.7. Drug product containers and closures.Drug product containers and closures.
  36. 36. 03/22/1503/22/15 Production & Process ControlProduction & Process Control 1.1. Written procedures;Written procedures; deviationsdeviations.. 2.2. Charge-in of components.Charge-in of components. 3.3. Calculation of yield.Calculation of yield. 4.4. Equipment identification.Equipment identification. 5.5. Sampling and testing of in-processSampling and testing of in-process materials and drug products.materials and drug products. 6.6. Time limitations on production.Time limitations on production. 7.7. Control of microbiological contamination.Control of microbiological contamination. 8.8. Reprocessing.Reprocessing.
  37. 37. 03/22/1503/22/15 Packaging & Labeling ControlPackaging & Labeling Control 1.1. Materials examination and usageMaterials examination and usage criteria.criteria. 2.2. Labeling issuance.Labeling issuance. 3.3. Packaging and labeling operations.Packaging and labeling operations. 4.4. Tamper-evident packagingTamper-evident packaging requirements for over-the-counterrequirements for over-the-counter (OTC) human drug products.(OTC) human drug products. 5.5. Drug product inspection.Drug product inspection. 6.6. Expiration dating.Expiration dating.
  38. 38. 03/22/1503/22/15 Handling & DistributionHandling & Distribution 1.1. Warehousing procedures.Warehousing procedures. 2.2. Distribution procedures.Distribution procedures.
  39. 39. 03/22/1503/22/15 Laboratory ControlLaboratory Control 1.1. General requirements.General requirements. 2.2. Testing and release for distribution.Testing and release for distribution. 3.3. Stability testing.Stability testing. 4.4. Special testing requirements.Special testing requirements. 5.5. Reserve samples.Reserve samples. 6.6. Laboratory animals.Laboratory animals. 7.7. Penicillin contamination.Penicillin contamination.
  40. 40. 03/22/1503/22/15 Records & ReportsRecords & Reports 1.1. General requirements.General requirements. 2.2. Equipment cleaning and use log.Equipment cleaning and use log. 3.3. Component, drug product container, closure,Component, drug product container, closure, and labeling records.and labeling records. 4.4. Master production and control records.Master production and control records. 5.5. Batch production and control records.Batch production and control records. 6.6. ProductionProduction record review.record review. 7.7. Laboratory records.Laboratory records. 8.8. Distribution records.Distribution records. 9.9. Complaint files.Complaint files.
  41. 41. 03/22/1503/22/15 Returned & Salvaged DrugReturned & Salvaged Drug ProductsProducts 1.1. Returned drug products.Returned drug products. 2.2. Drug product salvaging.Drug product salvaging.
  42. 42. 03/22/1503/22/15 THANK YOUTHANK YOU E-mail: Cell No: 9448716277