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  • GMP & Quality Assurance

    Mayur Sushir

    Dept of Microbiology

    MJC

  • Introduction

    GMP ensures that quality is built into the organization & processes involved in manufacture

    GMP covers all aspects of manufacture including collection, transportation, processing, storage, QC & delivery of the finished product

  • GMP

    Part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use.

    GMP is an integral part of QA.

  • QA, GMP & QC inter-relationship

    QA

    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, GMP & QC inter-relationship

    GMP

    Is that part of QA aimed at ensuring that products

    are consistently manufactured to a quality

    appropriate to their intended use

  • QA, GMP & QC inter-relationship

    QCPart 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 its

    quality

  • QC & QA

    Part of GMP which is concerned with sampling,

    specifications, testing and with in the organization, documentation and release procedures which ensure that the necessary & relevant tests are carried out

    QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use.

  • QC & QA

    Operational laboratory techniques & activities used to fulfill the requirement of Quality

    All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality

  • QC & QA

    QC is laboratory

    based

    QA is company

    based

  • GMP

    GMP in solid dosage forms

    GMP in semisolid dosage forms

    GMP in Liquid orals

    GMP in Parenterals Production

    GMP in Ayurvedic medicines

    GMP in Biotechnological products

    GMP in Nutraceuticals & cosmeceuticals

    GMP in Homeopathic medicines

  • GMP

    Good Manufacturing Practice

    Good Management Practice

    Get More Profit

    Give more Production

    GMP Training with out tears

  • Ten Principles of GMP

    1. Design & construct the facilities & equipments properly2. Follow written procedures & Instructions3. Document work4. Validate work5. Monitor facilities & equipment6. Write step by step operating procedures & work on

    instructions7. Design, develop & demonstrate job competence8. Protect against contamination9. Control components & product related processes10. Conduct planned & periodic audits

  • Beyond GMP

    Reduce pollution - Zero discharge

    Adaptation of environment friendly methods

    Consideration for better & healthier life tomorrow

    Consideration of ethics in life

    One should begin with end in mind otherwise it will be the beginning of the end

  • Cost of effective GMP

    In fact Cost benefits positive cost benefits of GMP/QA Good plant lay out, Smooth work flows, Efficient

    documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices

    Reduction in work in process & inventory holding costs Avoidance of cost of Quality failure ( cost of waste, of rework,

    of recall, of consumer compensation and of loss of company reputation)

  • List of important documents in GMP

    Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms & Formats Records

  • How do GMPs of different countries compare?

    At a high level, GMPs of various nations are very similar; mostrequire things like:

    Equipment & facilities being properly

    designed, maintained, & cleaned

    SOPs be written & approved

    An independent Quality unit (like QC and/or QA)

    Well trained personnel & management

  • Basic Requirements of GMP

    All manufacturing processes are clearly defined, systematically reviewed, & shown to be capable of consistently manufacturing medicinal products of the required quality & complying with specifications.

    Critical steps of the process and significant changes to the process are validated

  • Why GMP is important

    A poor quality medicine may contain toxic substances that have been unintentionally added.

    A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.

  • QUALITY RELATIONSHIP

    Quality Management

    Quality Assurance

    G.M.P.

    Quality Control

    QC

    GMP

    QA

  • What is Quality Management?

    The aspect of management function that determines

    & implements the quality policy

    The overall intention & direction regarding quality, as

    formally expressed & authorized by top management

    http://images.google.com.sg/imgres?imgurl=http://www.phys.uoa.gr/Atlas/MDT/upgrade/mdt_wireteam.jpg&imgrefurl=http://www.phys.uoa.gr/Atlas/MDT/Upgrade.html&h=480&w=640&sz=80&tbnid=gG8uxKyEuAYJ:&tbnh=101&tbnw=135&hl=en&start=54&prev=/images%3Fq%3D%2522production%2Bteam%2522%26start%3D40%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DN

  • BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)

    Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD).

    They should also comply with any other applicable regulations pertaining to your specific country.

    The attainment of this quality objective should be led by the senior management & requires the participation and commitment by staff, by the companys suppliers and distributors.

    http://images.google.com.sg/imgres?imgurl=http://upload.wikimedia.org/wikipedia/id/d/d6/ASEAN.gif&imgrefurl=http://id.wikipedia.org/wiki/ASEAN&h=150&w=150&sz=6&tbnid=YE-v_J-dojoJ:&tbnh=90&tbnw=90&hl=en&start=5&prev=/images%3Fq%3D%2522ASEAN%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DN

  • BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)

    To achieve the reliable quality objective, there should be a comprehensive QA system incorporating GMP.

    The QA system should be fully documented & its effectiveness should be monitored.

  • QUALITY ASSURANCE

    QA covers all matters which individually or collectively influence the quality of a product.

    All parts of QA system should be adequately resourced with:

    Competent personnelSuitable & sufficient premises, equipment & facilities

  • Principles of Quality Assurance (QA) Wide-ranging concept Covers all matters that individually or collectively influence

    the quality of a product Totality of the arrangements To ensure that the drug is of the right quality for the

    intended use QA incorporates GMP and also product design & development which is outside thescope of this module

  • BASIC REQUIREMENTS OFQA

    Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration.

    Ensure that managerial responsibilities are clearly specified. Ensure that production and control operations are clearly specified and

    GMP is adopted. Organize supply & use of correct starting & packaging materials. Ensure that finished products are correctly processed & checked before

    release.

    Ensure that products are released after review by authorized person.

    Provide satisfactory arrangement to ensure products are stored, distributed & handled appropriately.

    Put in place a mechanism for regular self inspection / internal quality audit.

  • GOOD MANUFACURING PRACTICES

    Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

    Minimize risks :

    cross contamination

    mix up

    Ensure products/materials are traceable to the original source.

    Product testing is not reliable way to assure product quality. Should BUILD quality into the product!

    Production and quality control functions should be independent of each other.

    All manufacturing process are clearly defined and systematically reviewed.

    http://images.google.com.sg/imgres?imgurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/graphics/verb/mixup2.jpg&imgrefurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/voc/voc26.html&h=308&w=266&sz=27&tbnid=n5wIqiON5wQJ:&tbnh=112&tbnw=96&hl=en&start=19&prev=/images%3Fq%3D%2522mix%2Bup%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DG

  • All necessary facilities/resources for GMP should be provided :

    adequate, qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services

    http://ceoic.com/manage/product/Mixer.jpg

  • QUALITY CONTROL

    QC is part of GMP.

    QC is concerned with sampling, specification and testing.

    Manufacturer should have a QC department.

    QC should be headed by an appropriately qualified and experi

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