Seminar on ……ISO series, guide of pharmaceuticalmanufacturing facilities, productivity                  By :              ...
Contents Introduction. History. ISO: 9000 series. ISO:14000 series. Guide to Pharmaceutical Manufacturing  Facilities...
Introduction    What are ISO 9000 Standards? ISO 9000 Standards   Define the required elements of an effective quality  ...
Background Who Created Standards• ISO WAS FORMED FEBRUARY 23, 1947 IN  GENEVA• FIRST FAMILY OF QUALITY STANDARD  RELEASED ...
How did ISO get started?          1906 - International Electro-technical Commission    1926 - International Federation of ...
ISO 9000 Consists of 5       Documents ISO 9000 Quality Management and Quality Assurance StandardsISO 9001 Quality Systems...
ISO 9000 Family of Standards•ISO 9000-2 - Generic guidelines for applying ISO 9001, ISO 9002, and                         ...
What has ISO Accomplished?• ISO film speed code• TL9000 Standard format for telephone and banking cards• ISO 9000 which pr...
ISO 9000:1987 series                  ISO 9000:1994 series  International Organisation           ISO 9000 was revised info...
QS-9000                         ISO9000:2000 series Ford, Chrysler, General                                           2nd ...
ISO9000:2000                                      Futureseries                                         Version : 2008 sta...
New ISO 9001                            Management                         Responsibility                                 ...
ISO 9001: Model                         Continual Improvement of                      the Quality Management System       ...
Principle Of New Standards                   Customer                    focus     Mutual   beneficial    supplier  relati...
Principles of new standard                       Customer focus      •Organization depends customers      •Understand curr...
Principles of new standard                System approach to Management    Identifying, understanding and managing interre...
Expectations of the newStandard Avoid the application of systems that are separate from the organization’s business proces...
Important changesCriteria               Previous version                        New VersionMain focus             Products...
Process approach                             Process definition            Set of interrelated or interacting activities w...
Process approach –Continual improvements of Process                      Understandings &                     meeting requ...
System Requirements / Structure of theStandard 4 Quality         5 ISO9000            6 ISO9000               7 ISO9000   ...
4 - Quality management system                                  Identification        Continual                 of processe...
4 - Quality management system              4.2 Document requirements                     Quality Policy                   ...
5 - Management Responsibility5.1          5.2        5.3        5.4                 5.6                  5.7Management   C...
5 - Management Responsibility   Development, implementation and    continually improvement of QMS                         ...
6 - Resource Management 6.1              6.2               6.3                                6.4                         ...
6 - Resource Management          Resources required to              Implementing, monitoring & continual              impr...
6 - Human Resources      Competent on the basis of appropriate        education, skill and experience                     ...
7 - Product Realization7.1           7.2                 7.3                    7.4                  7.5                 7...
7 - Product Realization                 Quality objectives of Products                            Processes, procedures to...
7 - Product Realization                               Identification of Customer / Market                               re...
7 - Product Realization                                  Planning                                  •Effective & efficient ...
7 - Product Realization                      Degree of control depends on effects of                      subsequent proce...
7 - Product Realization      Product      characteristics                   Procedures and work instructions              ...
8 - Measurement, analysis      and improvement8.1         8.2                 8.3                  8.4                    ...
8 - Measurement, analysis and improvement     8.1 - To demonstrate    • Conformity of the product    • Conformity to QMS r...
8 - Measurement, analysisand improvement  8.4 - Analysis of data  Collection and analysis of data generated through QMS  a...
8 - Measurement, analysis   and improvement                      8.5 - ImprovementsContinual Improvements   •QMS needed to...
Criteria for measurements–Satisfaction surveys for customers and other interested parties    •Feedback on products    •Cus...
Criteria for measurements                                      –Process capability / process validation   Processe        ...
What is ISO 14000?        Primarily concerned with Environmental Management            Minimize harmful effects on the env...
ISO 14004                        ISO 14010EMS - General Guidelines          EA- General Principles ofon Systems, Principle...
ISO 14022 EL- Symbols                     ISO 14024        ISO 14023                 EL- Practitioner Programs-EL- Testing...
Guides To Pharmaceutical ManufacturingFacilities & Productivity  Quality  Facilities and Equipment  Materials  Product...
Need of guidelines in pharmaceuticalsfacilities & productivity  Detailed guidelines of a system so that the   findings re...
Quality System           Quality must be built into the           process                         Quality is not tested in...
Role of Management in QS Management is responsible for: Organizational structure All Processes All Procedures Facilit...
Quality System Responsibilities Assures overall compliance          6) Reprocess/ Rework     with cGMPs                  ...
Laboratory Control System (I)Adequately staffed laboratories (supervisoryand bench personnel)                             ...
Laboratory Control System (II)Reference Standards (primary; secondary)                                Laboratory controls ...
Laboratory Control System (III)                  Investigation of “oos” results conducted in a timely                  man...
Laboratory Control System (IV)   Complete record of all data from testing         Record of all calculations              ...
Training                   (documente                      d; job-                     related)Implementationanddocumentat...
Production system (II)        Adequate written procedures & practice              for charge-in of materials       Identif...
Production system (III)    Process validation based on knowledge of process        (scientific basis for identifying criti...
Facilities & Equipment SystemLocation, design, construction appropriate to facilitatecleaning, maintenance, operations    ...
Facilities & Equipment System  Incoming materials    (id, quarantine)                   Sampling area (prevent            ...
Facilities & Equipment System    Identification clearly           marked                              Calibration         ...
Utilities    Qualified and appropriately monitored;        drawings should be available                                 De...
Water       Process water at minimum meeting WHO             guidelines for potable water                                 ...
Materials System      Written procedures for receipt, identification,   quarantine, storage, handling, sampling, testing a...
Materials System  Identification on large storage containers and associated manifolds, filling and discharge lines        ...
Materials System  Stored in manner to prevent degradation, contamination, no adverse effect on quality                    ...
Packaging & Labeling System    Written procedures for receipt, identification,quarantine, sampling, examination and/or tes...
Packaging & Labeling System All excess labels with batch #, destroyed         Obsolete labels destroyedPrinting devices co...
Packaging & Labeling System   Labels: API name, batch #, storage conditionsShipped API: Name/ address manufacturer; specia...
Benefits Certification demonstrates the recognition of quality  throughout organization Decrease in wasted time, materia...
References     Lachman L. Lieberman A. Kanig JL. The      Theory Of Industrial Pharmacy, 2nd edi,       Varghese Publicat...
Department of Pharmaceutics   9/2/2012   69
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ISO series, guide of pharmaceutical manufacturing facilities, productivity by kailash vilegave

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ISO series, guide of pharmaceutical manufacturing facilities, productivity ISO: 9000 series.
ISO:14000 series.
Guide to Pharmaceutical Manufacturing Facilities, Productivity

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ISO series, guide of pharmaceutical manufacturing facilities, productivity by kailash vilegave

  1. 1. Seminar on ……ISO series, guide of pharmaceuticalmanufacturing facilities, productivity By : Mr. Kailash Vilegave. Assit prof. Shivajirao S Jondhle college of pharmacy Asangaon 421601 Department of Pharmaceutics 9/2/2012 1
  2. 2. Contents Introduction. History. ISO: 9000 series. ISO:14000 series. Guide to Pharmaceutical Manufacturing Facilities, Productivity. References. Department of Pharmaceutics 9/2/2012 2
  3. 3. Introduction What are ISO 9000 Standards? ISO 9000 Standards  Define the required elements of an effective quality management system  Can be applied to any company  Adopted by the United States as the ANSI/ASQC Q90 series. STANDARD BODIES 154 COUNTRIES Bureau of Standards Jamaica Department of Pharmaceutics 9/2/2012 3
  4. 4. Background Who Created Standards• ISO WAS FORMED FEBRUARY 23, 1947 IN GENEVA• FIRST FAMILY OF QUALITY STANDARD RELEASED 1987 – To eliminate country to country differences – To eliminate terminology confusion – To increase quality awareness• FIRST ENVIRONMENTAL STANDARD RELEASED IN 1996 Department of Pharmaceutics 9/2/2012 4
  5. 5. How did ISO get started? 1906 - International Electro-technical Commission 1926 - International Federation of the National Standardizing Associations (ISA) 1946 London - delegates from 25 countries decided to create a newinternational organization "the object of which would be to facilitate the international coordination and unification of industrial standards 1947 - ISO began to officially function 1951 - The first ISO standard was published "Standard reference temperature for industrial length measurement". Department of Pharmaceutics 9/2/2012 5
  6. 6. ISO 9000 Consists of 5 Documents ISO 9000 Quality Management and Quality Assurance StandardsISO 9001 Quality Systems - QA Model for Design/Development,Production, Installation, and ServiceISO 9002 Quality Systems - QA Model for Production and Installation (nodesign)ISO 9003 Quality Systems - QA Model for Final Inspection and TestISO 9004 Quality Management and Quality System Elements -Guidelines Department of Pharmaceutics 9/2/2012 6
  7. 7. ISO 9000 Family of Standards•ISO 9000-2 - Generic guidelines for applying ISO 9001, ISO 9002, and •ISO 9003 ISO 9000-3 - Guidelines for applying ISO 9001 to the development, supply, and maintenance of software ISO 9000-4 Application for dependability management ISO 9004-2 Guidelines for services ISO 9004-3 Guidelines for processed material ISO 9004-4 Guidelines for quality improvement ISO 9004-5 Guidelines for quality plans •ISO 9004-6,7- Guidelines for project & configuration management Department of Pharmaceutics 9/2/2012 7
  8. 8. What has ISO Accomplished?• ISO film speed code• TL9000 Standard format for telephone and banking cards• ISO 9000 which provides a framework for quality management and quality assurance• ISO 14000 series provides a similar framework for environmental management• Internationally standardized freight containers• Standardized paper sizes.• Automobile control symbols• ISO international codes for country names, currencies and languages• AS 9100 the Aerospace Basic Quality System Standard Department of Pharmaceutics 9/2/2012 8
  9. 9. ISO 9000:1987 series ISO 9000:1994 series International Organisation ISO 9000 was revised infor Standards (ISO) adopted 1994 a series of quality standards, ISO 9000:1987 greater emphasis on quality assurance via preventive based on BS5750 actions.strongly influenced by the required evidence ofUS Department of Defence compliance with Military Standards documented procedures (MILspecs). tended to create a initial version was focused significant volume of on quality control using associated procedure retroactive checking ("do it as you document it") and corrective actions. manuals and bureaucracy. Department of Pharmaceutics 9/2/2012 9
  10. 10. QS-9000 ISO9000:2000 series Ford, Chrysler, General 2nd revision of Quality Motors and other Management System automotive/truck Requirement Standard from manufacturers identified International Organization for deficiencies in Standards ISO9000:1994 moved towards undertook a re- process performance metrics interpretation and reduced the need forextension to develop QS- documented procedures 9000 where clear evidence exists that the process is working additionally addressed well. continuousimprovement, manufacturin Replacement for previous ISOg capability and production 9001 / 9002 and 9003 part approval processes. standards of 1994 Department of Pharmaceutics 9/2/2012 10
  11. 11. ISO9000:2000 Futureseries Version : 2008 standards provide criteria for companies to TC 176, the ISO 9001 "certify" their quality technical committee management , has started its review on the next version of ISO  recertification is required 9001, which will in all every three years likelihood be termed the achieve "registration" by third- ISO 9001:2008 party auditor. standard, assuming its planned release date of the system 2008 is met. Early reports  verifies practice and are that the standard will processes not be substantially  provides objective 3rd changed from its 2000 version. party validation  enables benchmarking. Department of Pharmaceutics 9/2/2012 11
  12. 12. New ISO 9001 Management Responsibility Measurement, General Resource analysis & Generalrequirements management QMS improvements requirements Product Realization Continual Improvement cycle Department of Pharmaceutics 9/2/2012 12
  13. 13. ISO 9001: Model Continual Improvement of the Quality Management System 5.Management Responsibility CUSTOMERS CUSTOMERS Quality Management Satisfaction 6. Resource 8. Measurement Analysis and Management Improvement System 7. ProductRequirements Product Consumption Realization Department of Pharmaceutics 9/2/2012 13
  14. 14. Principle Of New Standards Customer focus Mutual beneficial supplier relationshi Based on eight p quality management Factual principles approach to decision making System Continual approach improveme to nt Manageme nt Department of Pharmaceutics 9/2/2012 14
  15. 15. Principles of new standard Customer focus •Organization depends customers •Understand current & future customer needs. •Meet / exceed customer expectations Leadership •Leaders establish purpose & direction of the organization •Should create & maintain environment to achieve organization’s objectives Involvement of People •People of all levels are essence of an organization •Their full involvement for organization’s benefit Process approach Desired results are achieved more efficiently when activities and resources are managed as process Department of Pharmaceutics 9/2/2012 15
  16. 16. Principles of new standard System approach to Management Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency Continual improvements Continual improvement of the organization’s overall performance should be a permanent objective of the organization Factual approach to decision making Effective decisions are based on the analysis of data and information Mutually beneficial supplier relationships •An organization & its suppliers are interdependent •Mutually beneficial relationship enhances the ability of both to create value Department of Pharmaceutics 9/2/2012 16
  17. 17. Expectations of the newStandard Avoid the application of systems that are separate from the organization’s business process Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business Enable Continual improvements of the system for enhanced customer satisfaction Enable compliance to statutory & regulatory requirements Department of Pharmaceutics 9/2/2012 17
  18. 18. Important changesCriteria Previous version New VersionMain focus Products Customer satisfactionApproach 20 quality elements Value adding processesProduct requirements Requirements specified by + Statutory & regulatory customer / organization requirementsInvolvement of What to do, When, Whom & How + Why it is to be donepeople to doImprovements Maintain the system Continual improvements requirements should be achieved Department of Pharmaceutics 9/2/2012 18
  19. 19. Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs Identify the Ensure Identify Identify Establish Interaction continual the the Inputs measurin s to other improvemenprocesses & outputs g criteria processes ts Do it for all value adding processes Department of Pharmaceutics 9/2/2012 19
  20. 20. Process approach –Continual improvements of Process Understandings & meeting requirements PLAN Continual improvementsProcesses in terms of Processes based on Of Added Value PDCA Cycle objective measurements DO ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK Department of Pharmaceutics 9/2/2012 20
  21. 21. System Requirements / Structure of theStandard 4 Quality 5 ISO9000 6 ISO9000 7 ISO9000 8 ISO9000 Manageme structure I structure II structure structure nt System Management Resource III Product IV Responsibility Management Realization Measureme nt Analysis General Management Provision of &improveme Planning requirements Commitment resources nt Customer General Documentation Customer focus Human Requirements resources related processes Monitoring & Quality policy Infrastructures measurement Design & development Control of NCP Planning Work environment Purchasing Analysis of data Responsibility, authority & Production & communication service Improvements provision Management Reviews Department of Pharmaceutics 9/2/2012 21
  22. 22. 4 - Quality management system Identification Continual of processes improvements required 4.1 General Criteria and requirements Monitoring and methods to ensure Measuring of Operation & control processes Availability of information & resources for operation & control Department of Pharmaceutics 9/2/2012 22
  23. 23. 4 - Quality management system 4.2 Document requirements Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities Records Department of Pharmaceutics 9/2/2012 23
  24. 24. 5 - Management Responsibility5.1 5.2 5.3 5.4 5.6 5.7Management Customer Quality Planning Responsibility Managementcommitment focus policy authority & Review communicate Quality Responsibility General objectives & authority Review QMS Management inputs planning representative Review Internal outputs communication Department of Pharmaceutics 9/2/2012 24
  25. 25. 5 - Management Responsibility Development, implementation and continually improvement of QMS Establishment of •Quality Policy •Quality Objectives Top Management’s Identification of Customer requirements commitment Communication of importance of•Appointment of Management •Regulatory & statutory requirements Representative •Meeting customer requirements•Conducting Management •Quality Policy & Quality objectivesReviews •Responsibilities & authorities•Providing required resources Department of Pharmaceutics 9/2/2012 25
  26. 26. 6 - Resource Management 6.1 6.2 6.3 6.4 Infrastructures Provision of Human Work resources Resources Environment General Competence, awareness & training Department of Pharmaceutics 9/2/2012 26
  27. 27. 6 - Resource Management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements Human Resources ResourceManagemen t Infrastructures Infrastructures needed to achieve product conformity Work environment Work environment needed to achieve product conformity Department of Pharmaceutics 9/2/2012 27
  28. 28. 6 - Human Resources Competent on the basis of appropriate education, skill and experience Define competencies for people performing work affecting product quality 6.2 Human Provide training or actions Resource s Evaluate effectiveness of the training / actions Employees should aware importance of the activity being performed Department of Pharmaceutics 9/2/2012 28
  29. 29. 7 - Product Realization7.1 7.2 7.3 7.4 7.5 7.6Planning Customer Design and Purchasing Production Control ofof product related development & service monitoring processes provision measuringrealization devices Identification of Design planning Purchasing Control customer process requirement Design inputs Validation of Purchasing processes Review of Design outputs information customer Identification & requirement traceability Design review Verification of purchased products Customer Design Customer communication verification property Design validation Preservation of product Design Changes Department of Pharmaceutics 9/2/2012 29
  30. 30. 7 - Product Realization Quality objectives of Products Processes, procedures to realize product7.1Planning ofProduct Verification, validation, monitoring, insrealization pection and testing of product Record to demonstrate conformance Department of Pharmaceutics 9/2/2012 30
  31. 31. 7 - Product Realization Identification of Customer / Market requirements •Specified by customer •Requirements taken for granted7.2 •Statutory / Regulatory requirementsCustomer relatedprocesses – Review of requirements related(Sales) product prior to acceptance / commitment to customers - ability to meet customer requirements Effective communication with customer in relation to •Product information •Sales order handling •Customer feedback •Customer complaints Department of Pharmaceutics 9/2/2012 31
  32. 32. 7 - Product Realization Planning •Effective & efficient •Expectations of interested parties 7.3 Design andDevelopment – (Product) Design inputs and outputs Review and verification, validation and control of changes •Accuracy •Potential hazards & faults •Corrections •Evaluations against lessons learnedPharmaceutics 9/2/2012 Department of 32
  33. 33. 7 - Product Realization Degree of control depends on effects of subsequent processes and effect on final product 7.4 Purchasing Supplier evaluation Purchasing is done in controlled manner to ensure that purchased products conforms to specific Verification of purchased product – requirements Inspection and testing Department of Pharmaceutics 9/2/2012 33
  34. 34. 7 - Product Realization Product characteristics Procedures and work instructions Suitable equipments to manufacture.7.5 Monitoring and inspection & testingProduction andservice provision Product release, delivery and postManufacturing / deliveryservice provisionunder controlled Process validationcondition to ensureconformity of product Identification and traceability Customers property Material supplied by customers – e.g.. 3rd party blending Department of Pharmaceutics 9/2/2012 34
  35. 35. 8 - Measurement, analysis and improvement8.1 8.2 8.3 8.4 8.5 Control ofGeneral Monitoring & non Analysis Improvement measurements conforming of data product Customer Continual satisfaction improvements Internal audits Corrective action Measurement of processes Preventive action Measurement of product Department of Pharmaceutics 9/2/2012 35
  36. 36. 8 - Measurement, analysis and improvement 8.1 - To demonstrate • Conformity of the product • Conformity to QMS requirements • Continually improvements and the effectiveness of the system 8.2 - Monitoring and Measurements •Customer satisfaction / perception •Internal audits - conformity planned arrangements of QMS and ISO9001 •Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results •Monitoring and measurements of product – Conformity to product requirements 8.3 - Control of NCP •To assure that NCP products are identified and controlled to prevent unintended use / delivery Department of Pharmaceutics 9/2/2012 36
  37. 37. 8 - Measurement, analysisand improvement 8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system Analysis shall provide information related to •Customer satisfaction / perception •Conformity to specs, requirements •Trends of processes and products • Opportunities for preventive actions •Suppliers Department of Pharmaceutics 9/2/2012 37
  38. 38. 8 - Measurement, analysis and improvement 8.5 - ImprovementsContinual Improvements •QMS needed to be continually improvedCorrective action •Actions to prevent recurrence of NCP, NCR etc •Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant recordsPreventive action •Actions against potential non conformities to avoid their occurrence •Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records Department of Pharmaceutics 9/2/2012 38
  39. 39. Criteria for measurements–Satisfaction surveys for customers and other interested parties •Feedback on products •Customer & market requirements –Financial measurements •Prevention cost System •Non conforming / failure cost performanc •Lifecycle cost e Self assessment –Internal audits •Effectiveness & efficiency of processes •Opportunities for improvements •Use of data / information •Effective & efficient use of resources •Adequacy, accuracy and performance of measurements •Relationships with customers/ suppliers/ other interested parties Department of Pharmaceutics 9/2/2012 39
  40. 40. Criteria for measurements –Process capability / process validation Processe –Reaction time s –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction Products –Inspection and testing of incoming, in process and final product –Product verification –Product validation Department of Pharmaceutics 9/2/2012 40
  41. 41. What is ISO 14000? Primarily concerned with Environmental Management Minimize harmful effects on the environment Continual Improvement of environmental performanceThe formation of ISO Technical Committee 207 (TC 207) in 1993 marksthe beginning of the development of the ISO 14000 series. The USTechnical Advisory Group (TAG) for ISO/TC 207 (US/TAG for ISO/TC207) represents the United States in international negotiation on ISO14000 ISO 14000 ISO 14001 EMS- General Guidelines on EMS- Specification with Principles, Systems and Guidance for Use requires a Supporting Techniques substantial commitment of time and resources Department of Pharmaceutics 9/2/2012 41
  42. 42. ISO 14004 ISO 14010EMS - General Guidelines EA- General Principles ofon Systems, Principles and Environmental Auditing Supporting Techniques ISO 14012 ISO 14011 EA- Qualification Criteria for EA- Auditing of Environmental AuditorsEnvironmental Management Systems ISO 14014 Initial Reviews ISO 14013 ISO 14015 Management of Environmental Audit Environmental Site Assessments Programs ISO 14021 ISO 14020 EL- Self Declaration- EL- Basic Principles of Environmental Claims- Terms Environmental Labeling and Definitions Department of Pharmaceutics 9/2/2012 42
  43. 43. ISO 14022 EL- Symbols ISO 14024 ISO 14023 EL- Practitioner Programs-EL- Testing and Verification Guiding principles, practices Methodologies and certification procedures of multiple criteria (type1) ISO 14031 ISO 14040Environmental Performance LCA- General Principles and Evaluation Practices ISO 14041 ISO 14042 LCA- Goal and LCA- Impact Assessment Definition/Scope and ISO 14043 Inventory Assessment LCA- Improvement ISO 14060 Assessment Guide for the Inclusion of ISO 14050 Environmental Aspects in Terms and Definitions Product Standards Department of Pharmaceutics 9/2/2012 43
  44. 44. Guides To Pharmaceutical ManufacturingFacilities & Productivity  Quality  Facilities and Equipment  Materials  Production  Packaging/Labeling  Laboratory Controls Department of Pharmaceutics 9/2/2012 44
  45. 45. Need of guidelines in pharmaceuticalsfacilities & productivity  Detailed guidelines of a system so that the findings reflect the state of control in that system for every product (profile) class  If one of the six systems is out of control, the firm is considered out of control  A system is considered out of control based on GMP deficiencies which suggest lack of assurance of quality Department of Pharmaceutics 9/2/2012 45
  46. 46. Quality System Quality must be built into the process Quality is not tested into the product Quality System Assurance of Quality comes from - Design of robust process based on thorough knowledge of that process and the sources of variabilityEffective Quality System in place Department of Pharmaceutics 9/2/2012 46
  47. 47. Role of Management in QS Management is responsible for: Organizational structure All Processes All Procedures Facilities & Resources In short, everything to insure product quality, customer satisfaction and continuous improvement Department of Pharmaceutics 9/2/2012 47
  48. 48. Quality System Responsibilities Assures overall compliance 6) Reprocess/ Rework with cGMPs 7) Validation/ Revalidation Review and approval duties 8) Rejects for: 9) Stability Failures/ Out of1) Product Quality Reviews (at trend data least annually) 10) Quarantine products2) Complaint reviews 11) Documented GMP & Job3) Discrepancy/ failure Related Training investigations4) Change Control5) CAPA (Corrective And Preventive Action) Department of Pharmaceutics 9/2/2012 48
  49. 49. Laboratory Control System (I)Adequately staffed laboratories (supervisoryand bench personnel) Written specifications for raw materials, intermediates, APIs, label Laboratory Control s & packaging System: Written procedures for sampling, testing, approval or rejection of Adequate lab facilities materials and for the recording and under the Quality Unit storage of data which is independent from Production Method validation/ revalidation Validation and Security for computerized handling of test results and related data; system for assuring integrity of all lab data Department of Pharmaceutics 9/2/2012 49
  50. 50. Laboratory Control System (II)Reference Standards (primary; secondary) Laboratory controls followed and documented Laboratory Control System Calibration: written procedures, schedule, documentation Equipment Qualification Written procedure (SOP) covering out of specification “oos” results Department of Pharmaceutics 9/2/2012 50
  51. 51. Laboratory Control System (III) Investigation of “oos” results conducted in a timely manner as per SOP and documented (complete records maintained).Laboratory Conclusions from “oos” investigationsControl documented and corrective actions/ needSystem for addition investigation identified and implemented. “oos” review included in Product Quality Reviews Description of samples Identification of method used Raw data for sample/ standard preparation, reagents Department of Pharmaceutics 9/2/2012 51
  52. 52. Laboratory Control System (IV) Complete record of all data from testing Record of all calculations Statement of the test results; how compare with established acceptance criteriaLaboratory ControlSystem Signature of the person who performed each test; dates tests performed Date/ signature of second qualified person who reviewed original test records for accuracy, completeness and compliance with established standards Department of Pharmaceutics 9/2/2012 52
  53. 53. Training (documente d; job- related)Implementationanddocumentation Productionof in-process System (I)controls, tests,andexaminations Contemporaneous, accura te and complete batch production documentation Department of Pharmaceutics 9/2/2012 53
  54. 54. Production system (II) Adequate written procedures & practice for charge-in of materials Identification of equipment with contents, stage of manufacturing, status Equipment cleaning records Established time limits for completion of production steps/ stages Deviations investigated and documented contemporaneously with investigation Department of Pharmaceutics 9/2/2012 54
  55. 55. Production system (III) Process validation based on knowledge of process (scientific basis for identifying critical steps/ critical process parameters/control points) Justification and consistency of in-process specifications and final product specifications Data/ information documented and available to Quality Unit for review (trending, investigations etc.) Department of Pharmaceutics 9/2/2012 55
  56. 56. Facilities & Equipment SystemLocation, design, construction appropriate to facilitatecleaning, maintenance, operations Layout and air handling designed and constructed to prevent cross- contamination Facilities & Equipment Flow of materials & personnel designed System to prevent mix-ups or contamination Defined areas or other control systems to prevent mix-ups or contamination includes as: Department of Pharmaceutics 9/2/2012 56
  57. 57. Facilities & Equipment System Incoming materials (id, quarantine) Sampling area (prevent contamination) Quarantine (intermediates, APIs)Facilities & Released materialsEquipmentSystem Rejection b) EQUIPMENTS Appropriate design, size, location, non-reactive product contact surfaces Department of Pharmaceutics 9/2/2012 57
  58. 58. Facilities & Equipment System Identification clearly marked Calibration Preventive Maintenance schedule and procedures Facilities & Cleaning procedures and validation Equipment System: b) Records of use, cleaning, maintenance EQUIPMENTS Closed or contained equipment. - Inspection prior to useSeparate facilities or containment where needed (penicillins, highlypotent compounds etc.) Department of Pharmaceutics 9/2/2012 58
  59. 59. Utilities Qualified and appropriately monitored; drawings should be available Designed and constructed to prevent contamination or cross-contamination Utilities Recirculated air to production (same concern) Permanently installed pipe work should be appropriately identifiedDrains of adequate size with air break Department of Pharmaceutics 9/2/2012 59
  60. 60. Water Process water at minimum meeting WHO guidelines for potable water Justify quality of water used to achieve stated API quality and establish specifications Water Water treatment facilities validation API to be used for incorporation into sterile dosage form – water used inlater stages should be monitored and controlled for total microbial counts, objectionable organisms and endotoxins Department of Pharmaceutics 9/2/2012 60
  61. 61. Materials System Written procedures for receipt, identification, quarantine, storage, handling, sampling, testing and approval or rejection of materials System to evaluate suppliers (critical materials) Purchased against agreed specification Materials Change control process for System changing suppliers Upon receipt check for correct labeling, seals Before co-mingling bulk material, id/testAssurances obtained from non-dedicatedtankers Department of Pharmaceutics 9/2/2012 61
  62. 62. Materials System Identification on large storage containers and associated manifolds, filling and discharge lines Code given to received batches; status identity Materials At minimum, a specific identity test System on incoming batches. Supplier evaluation should include three fully tested batches; one fully tested batch/year Written sampling plan with justificationPrevent contamination of sampled containers Department of Pharmaceutics 9/2/2012 62
  63. 63. Materials System Stored in manner to prevent degradation, contamination, no adverse effect on quality Drums, bags, boxes off the floorMaterialsSystem First in, first out Rejected materials identified and controlled under a quarantine systemEstablished re-test/ re-evaluation periods Department of Pharmaceutics 9/2/2012 63
  64. 64. Packaging & Labeling System Written procedures for receipt, identification,quarantine, sampling, examination and/or testing P&L P&L should conform to specifications Records maintained for each shipment (showing receipt, examination & result) Containers protective, clean, not alter product quality; if re-used, cleaned & labeling defaced Access to label storage area limited Written procedures for reconciliation; - investigation if discrepancy Department of Pharmaceutics 9/2/2012 64
  65. 65. Packaging & Labeling System All excess labels with batch #, destroyed Obsolete labels destroyedPrinting devices controlled to insure accuracy of label (against batch record) Print labels checked against master and a copy placed into the batch recordDocumented procedures to assure correct packaging materials/ labels used Operations designed to prevent mix-ups Department of Pharmaceutics 9/2/2012 65
  66. 66. Packaging & Labeling System Labels: API name, batch #, storage conditionsShipped API: Name/ address manufacturer; special transport conditions; expiry/ retest date Documented clearance before operations Packaged/ labeled intermediates or APIs examined as part of packaging (documented) Seal employed to assure package integrity Department of Pharmaceutics 9/2/2012 66
  67. 67. Benefits Certification demonstrates the recognition of quality throughout organization Decrease in wasted time, materials, and efforts. Inculcating values of excellence and best practices. Establish leadership role within organization. Increased recognition by international partners Ability to maintain standards of quality and excellence. Department of Pharmaceutics 9/2/2012 67
  68. 68. References  Lachman L. Lieberman A. Kanig JL. The Theory Of Industrial Pharmacy, 2nd edi, Varghese Publication House; Bombay-14  Gilbert s. Banker, Christoher T. Rhodes, Modern Pharmaceutics, 3rd edi, New York.  Sharma PP. How To Practice GMPs, 2nd edi, Vandana Publication; Agra.  www.google.com  www.wikipedia.com  www.kwaliteg.co.za.iso:9000.com  www.fda.com Department of Pharmaceutics 9/2/2012 68
  69. 69. Department of Pharmaceutics 9/2/2012 69

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