iso by kailash vilegave , S. S jondhle college of Pharmacy Asangaon

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

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Seminar on ……ISO series, guide of pharmaceutical manufacturing facilities, productivity : 

Seminar on ……ISO series, guide of pharmaceutical manufacturing facilities, productivity By : Mr. Kailash Vilegave. Assit prof. Shivajirao S Jondhle college of pharmacy Asangaon 421601 9/2/2012 Department of Pharmaceutics 1

Contents : 

Contents Introduction. History. ISO: 9000 series. ISO:14000 series. Guide to Pharmaceutical Manufacturing Facilities, Productivity. References. 9/2/2012 Department of Pharmaceutics 2

IntroductionWhat are ISO 9000 Standards? : 

IntroductionWhat 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. 9/2/2012 Department of Pharmaceutics 3 154 COUNTRIES Bureau of Standards Jamaica STANDARD BODIES

Slide 4: 

9/2/2012 Department of Pharmaceutics 4 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 Background Who Created Standards

How did ISO get started? : 

How did ISO get started? 9/2/2012 Department of Pharmaceutics 5 1906 - International Electro-technical Commission 1926 - International Federation of the National Standardizing Associations (ISA) 1946 London - delegates from 25 countries decided to create a new international 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".

ISO 9000 Consists of 5 Documents : 

ISO 9000 Consists of 5 Documents ISO 9000 Quality Management and Quality Assurance Standards 9/2/2012 Department of Pharmaceutics 6 ISO 9001 Quality Systems - QA Model for Design/Development, Production, Installation, and Service ISO 9002 Quality Systems - QA Model for Production and Installation (no design) ISO 9003 Quality Systems - QA Model for Final Inspection and Test ISO 9004 Quality Management and Quality System Elements - Guidelines

Slide 7: 

9/2/2012 Department of Pharmaceutics 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

Slide 8: 

9/2/2012 Department of Pharmaceutics 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

Slide 9: 

9/2/2012 Department of Pharmaceutics 9 ISO 9000:1987 series International Organisation for Standards (ISO) adopted a series of quality standards, ISO 9000:1987 based on BS5750 strongly influenced by the US Department of Defence Military Standards (MILspecs). initial version was focused on quality control using retroactive checkingand corrective actions. ISO 9000:1994 series ISO 9000 was revised in 1994 greater emphasis on quality assurance via preventive actions. required evidence of compliance with documented procedures tended to create a significant volume of associated procedure("do it as you document it") manuals and bureaucracy.

Slide 10: 

9/2/2012 Department of Pharmaceutics 10 QS-9000 Ford, Chrysler, General Motors and other automotive/truck manufacturers identified deficiencies in ISO9000:1994 undertook a re-interpretation and extension to develop QS-9000 additionally addressed continuous improvement, manufacturing capability and production part approval processes. ISO9000:2000 series 2nd revision of Quality Management System Requirement Standard from International Organization for Standards moved towardsprocess performance metrics reduced the need fordocumented procedures where clear evidence exists that the process is working well. Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994

ISO9000:2000 series : 

ISO9000:2000 series standards provide criteria for companies to "certify" their quality management recertification is required every three years achieve "registration" by third-party auditor.  the system verifies practice and processes provides objective 3rd party validation enables benchmarking. TC 176, the ISO 9001 technical committee , has started its review on the next version of ISO 9001, which will in all likelihood be termed the ISO 9001:2008 standard, assuming its planned release date of 2008 is met. Early reports are that the standard will not be substantially changed from its 2000 version. 9/2/2012 Department of Pharmaceutics 11 Future Version : 2008

New ISO 9001 : 

New ISO 9001 9/2/2012 Department of Pharmaceutics 12 QMS Resource management Measurement, analysis & improvements Product Realization Management Responsibility Continual Improvement cycle

ISO 9001: Model : 

ISO 9001: Model 9/2/2012 Department of Pharmaceutics 13 CUSTOMERS CUSTOMERS Quality Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8. Measurement Analysis and Improvement Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product

Principle Of New Standards : 

Principle Of New Standards 9/2/2012 Department of Pharmaceutics 14 Based on eight quality management principles Leadership Process approach Involvement of people System approach to Management Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus

Principles of new standard : 

Principles of new standard 9/2/2012 Department of Pharmaceutics 15 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

Principles of new standard : 

Principles of new standard 9/2/2012 Department of Pharmaceutics 16 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

Expectations of the new Standard : 

Expectations of the new Standard 9/2/2012 Department of Pharmaceutics 17 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

Important changes : 

Important changes 9/2/2012 Department of Pharmaceutics 18

Process approach : 

Process approach 9/2/2012 Department of Pharmaceutics 19 Process definition Set of interrelated or interacting activities which transforms inputs into outputs Ensure continual improvements Do it for all value adding processes

Process approach – Continual improvements of Process : 

Process approach – Continual improvements of Process 9/2/2012 Department of Pharmaceutics 20 PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK Understandings & meeting requirements PLAN

System Requirements / Structure of the Standard : 

9/2/2012 Department of Pharmaceutics 21 System Requirements / Structure of the Standard 4 Quality Management System

4 - Quality management system : 

4 - Quality management system 9/2/2012 Department of Pharmaceutics 22 4.1 General requirements Identification of processes required Criteria and methods to ensure Operation & control Availability of information & resources for operation & control Monitoring and Measuring of processes Continual improvements

4 - Quality management system : 

4 - Quality management system 9/2/2012 Department of Pharmaceutics 23 Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities Records 4.2 Document requirements

5 - Management Responsibility : 

5 - Management Responsibility 9/2/2012 Department of Pharmaceutics 24 5.1 Management commitment

5 - Management Responsibility : 

5 - Management Responsibility 9/2/2012 Department of Pharmaceutics 25 Top Management’s commitment

6 - Resource Management : 

6 - Resource Management 9/2/2012 Department of Pharmaceutics 26 6.1 Provision of resources

6 - Resource Management : 

6 - Resource Management 9/2/2012 Department of Pharmaceutics 27 Resource Management

6 - Human Resources : 

6 - Human Resources 9/2/2012 Department of Pharmaceutics 28 6.2 Human Resources

7 - Product Realization : 

7 - Product Realization 9/2/2012 Department of Pharmaceutics 29 7.1 Planning of product realization

7 - Product Realization : 

7 - Product Realization 9/2/2012 Department of Pharmaceutics 30 7.1 Planning of Product realization

7 - Product Realization : 

7 - Product Realization 9/2/2012 Department of Pharmaceutics 31 7.2 Customer related processes – (Sales)

7 - Product Realization : 

7 - Product Realization 9/2/2012 Department of Pharmaceutics 32 7.3 Design and Development – (Product)

7 - Product Realization : 

7 - Product Realization 9/2/2012 Department of Pharmaceutics 33 7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements

7 - Product Realization : 

7 - Product Realization 9/2/2012 Department of Pharmaceutics 34 7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product

8 - Measurement, analysis and improvement : 

8 - Measurement, analysis and improvement 9/2/2012 Department of Pharmaceutics 35 8.1 General

8 - Measurement, analysis and improvement : 

8 - Measurement, analysis and improvement 9/2/2012 Department of Pharmaceutics 36 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 8.1 - To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system

8 - Measurement, analysis and improvement : 

8 - Measurement, analysis and improvement 9/2/2012 Department of Pharmaceutics 37 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

8 - Measurement, analysis and improvement : 

8 - Measurement, analysis and improvement 9/2/2012 Department of Pharmaceutics 38 8.5 - Improvements Continual Improvements QMS needed to be continually improved Corrective 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 records Preventive 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

Criteria for measurements : 

Criteria for measurements 9/2/2012 Department of Pharmaceutics 39 System performance

Criteria for measurements : 

Criteria for measurements 9/2/2012 Department of Pharmaceutics 40 Products Processes

What is ISO 14000? : 

What is ISO 14000? 9/2/2012 Department of Pharmaceutics 41 Primarily concerned with Environmental Management Minimize harmful effects on the environment Continual Improvement of environmental performance The formation of ISO Technical Committee 207 (TC 207) in 1993 marks the beginning of the development of the ISO 14000 series. The US Technical Advisory Group (TAG) for ISO/TC 207 (US/TAG for ISO/TC 207) represents the United States in international negotiation on ISO 14000 ISO 14000 EMS- General Guidelines on Principles, Systems and Supporting Techniques ISO 14001 EMS- Specification with Guidance for Use requires a substantial commitment of time and resources

Slide 42: 

9/2/2012 Department of Pharmaceutics 42 ISO 14004 EMS - General Guidelines on Systems, Principles and Supporting Techniques ISO 14010 EA- General Principles of Environmental Auditing ISO 14011 EA- Auditing of Environmental Management Systems ISO 14012 EA- Qualification Criteria for Environmental Auditors ISO 14013 Management of Environmental Audit Programs ISO 14014 Initial Reviews ISO 14015 Environmental Site Assessments ISO 14020 EL- Basic Principles of Environmental Labeling ISO 14021 EL- Self Declaration- Environmental Claims- Terms and Definitions

Slide 43: 

9/2/2012 Department of Pharmaceutics 43 ISO 14022 EL- Symbols ISO 14023 EL- Testing and Verification Methodologies ISO 14024 EL- Practitioner Programs- Guiding principles, practices and certification procedures of multiple criteria (type1) ISO 14031 Environmental Performance Evaluation ISO 14040 LCA- General Principles and Practices ISO 14041 LCA- Goal and Definition/Scope and Inventory Assessment ISO 14042 LCA- Impact Assessment ISO 14043 LCA- Improvement Assessment ISO 14050 Terms and Definitions ISO 14060 Guide for the Inclusion of Environmental Aspects in Product Standards

Guides To Pharmaceutical Manufacturing Facilities & Productivity : 

Guides To Pharmaceutical Manufacturing Facilities & Productivity Quality Facilities and Equipment Materials Production Packaging/Labeling Laboratory Controls 9/2/2012 Department of Pharmaceutics 44

Need of guidelines in pharmaceuticals facilities & productivity : 

Need of guidelines in pharmaceuticals facilities & 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 9/2/2012 Department of Pharmaceutics 45

Slide 46: 

9/2/2012 Department of Pharmaceutics 46 Quality System Quality System

Role of Management in QS : 

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 9/2/2012 Department of Pharmaceutics 47

Quality System Responsibilities : 

Quality System Responsibilities Assures overall compliance with cGMPs Review and approval duties for: Product Quality Reviews (at least annually) Complaint reviews Discrepancy/ failure investigations Change Control CAPA (Corrective And Preventive Action) 6) Reprocess/ Rework 7) Validation/ Revalidation 8) Rejects 9) Stability Failures/ Out of trend data 10) Quarantine products 11) Documented GMP & Job Related Training 9/2/2012 Department of Pharmaceutics 48

Slide 49: 

9/2/2012 Department of Pharmaceutics 49 Laboratory Control System (I) Laboratory Control System: Adequate lab facilities under the Quality Unit which is independent from Production

Slide 50: 

9/2/2012 Department of Pharmaceutics 50 Laboratory Control System (II) Laboratory Control System

Slide 51: 

9/2/2012 Department of Pharmaceutics 51 Laboratory Control System (III) Laboratory Control System

Slide 52: 

9/2/2012 Department of Pharmaceutics 52 Laboratory Control System (IV) Laboratory Control System

Slide 53: 

9/2/2012 Department of Pharmaceutics 53 Production System (I) Master production and control records Change control procedure Batch production and control records Contemporaneous, accurate and complete batch production documentation Implementation and documentation of in-process controls, tests, and examinations Training (documented; job-related)

Production system (II) : 

Production system (II) 9/2/2012 Department of Pharmaceutics 54 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 Adequate written procedures & practice for charge-in of materials

Production system (III) : 

Production system (III) 9/2/2012 Department of Pharmaceutics 55 Justification and consistency of in-process specifications and final product specifications Data/ information documented and available to Quality Unit for review (trending, investigations etc.) Process validation based on knowledge of process (scientific basis for identifying critical steps/ critical process parameters/control points)

Slide 56: 

9/2/2012 Department of Pharmaceutics 56 Facilities & Equipment System Facilities & Equipment System

Slide 57: 

9/2/2012 Department of Pharmaceutics 57 Facilities & Equipment System Facilities & Equipment System

Slide 58: 

9/2/2012 Department of Pharmaceutics 58 Facilities & Equipment System Facilities & Equipment System: b) EQUIPMENTS

Slide 59: 

9/2/2012 Department of Pharmaceutics 59 Utilities Utilities

Slide 60: 

9/2/2012 Department of Pharmaceutics 60 Water Water

Slide 61: 

9/2/2012 Department of Pharmaceutics 61 Materials System Materials System

Slide 62: 

9/2/2012 Department of Pharmaceutics 62 Materials System Materials System

Slide 63: 

9/2/2012 Department of Pharmaceutics 63 Materials System Materials System

Slide 64: 

9/2/2012 Department of Pharmaceutics 64 Packaging & Labeling System 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 Written procedures for receipt, identification, quarantine, sampling, examination and/or testing P&L

Slide 65: 

9/2/2012 Department of Pharmaceutics 65 Packaging & Labeling System Obsolete labels destroyed Printing devices controlled to insure accuracy of label (against batch record) Print labels checked against master and a copy placed into the batch record Documented procedures to assure correct packaging materials/ labels used Operations designed to prevent mix-ups All excess labels with batch #, destroyed

Slide 66: 

9/2/2012 Department of Pharmaceutics 66 Packaging & Labeling System Shipped 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 Labels: API name, batch #, storage conditions

Benefits : 

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. 9/2/2012 Department of Pharmaceutics 67

References : 

References 9/2/2012 Department of Pharmaceutics 68 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

Slide 69: 

9/2/2012 Department of Pharmaceutics 69

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