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Quality - Coggle Diagram

- - - - fit for their intended use
      - comply with marketing authorization
      - do not place patients at risk due to inadequate safety, quality and efficacy
  - - - intenational standard specifying requirements for QMS
      - most prominent approach to QMS
    - - meeting the customer's requirements
        
        instill confidence int he organization
        
        more customers, more sales, more repeat
      - meeting the organization requirements
        
        ensures compliance with regulations
        
        provision of products and services in the most cost- and resource-efficient manner
        
        expansion, growth and profit
    - - focus on customers
      - provide strong leadership
      - involve people
      - adopt process-driven approach
      - adopt a systematic approach to management
      - commit to continual improvement
      - adopt a factual approach to decision making
      - recognize that supplier relations are mutually beneficial
    - - organization's quality policy and quality objectives
      - quality manual
      - procedure, instruction and records
      - data management
      - internal processes
      - customer satisfaction from product quality
      - improvement opportunities
    - - design
      - build
      - deploy
      - control
      - measure
      - review
      - improve
      - plan-do-check-act (PDCA) cycle
- - - - material evaluation
        
        raw material
        
        packaging material
      - in-process product evaluation
      - finished product evaluation
      - analytical testing
      - part of GMP that deals with testing of the environment, facilities, materials, components, and products in accordance with standards
        
        performed by the QC Department as required by the manufacturing authorization
        
        QC departments is independent from prodcutin and other departments
        
        under the authority of a qualified and experienced person
      - functions
        
        sampling approved by QC department
        
        validated test methods and records
        
        review and evaluation of production documentation
        
        failure investigations for all deviations
        
        ingredients comply with the marketing authorization and are of required purity
        
        proper containers with correct labelling
        
        release of batches by authorized person
        
        retained samples of starting materials and products
        
        establish QC procedures
        
        reference standards
        
        correct labeling
        
        stability testing
        
        complaint investigation
        
        environmental monitoring
        
        production conditions
        
        in-process test results
        
        manufacturing documents
        
        compliance with FP specifications
        
        examination of the finished pack
    - - documentation
      - stability testing
      - validation
      - GMP compliance
      - supplier quality management
      - totality of arrangements to ensure that the drug is of the right quality for the intended use
        
        incoporates GMP
        
        ensures products are developed correclty
      - requirements
        
        products are developed correclty
        
        managerial responsibilities are identified
        
        organized supply and use of correct starting materials
        
        defined control for all stages of manufacture and packaging
        
        finished product correctly processed and checked before the release
        
        products are reviewed by authorized person before release
        
        storage and distributiion are provided
        
        organized self-inspection
      - GMP
        
        part of QA which ensures products are consistenlty produced and controlled to the quality standards appropriate for their intended use
        
        diminishes risks that cannot be controlled by testing of product
        
        elements
        
        QMS
        
        personnel
        
        premises
        
        equipment
        
        sanitation and hygiene
        
        production
        
        quality control
        
        documentation
        
        self-inspection and quality audits
        
        storage areas
        
        complaints and product recalls
        
        contract production and analysis
        
        basic rules
        
        make sure that you have the correct written instructions before starting the job
        
        follow the instructions EXACTLY; do not take shortcut
        
        make sure that you use the correct materials
        
        use the correct equipment and make sure that it is clean
        
        prevent contamination and mix ups
        
        always watch for labeling errors
        
        work accurately and precisely
        
        keep everything, including yourself, clean and tidy
        
        watch for errors, bad practices and mistakes and report them immediately
        
        make clear accurate records of what has been done and the checks that been carried out
    - - sampling, inspection, testing, evaluation, and release of RM and PM
      - sampling, inspection, testing, evaluation and release (IP and FP)
      - Analytical testing of materials and products
      - laboratory services
      - maintains updated technical documents
      - issues documents
      - conducts periodic GMP audits
      - validaton of facilities (utilities), equipment and processes
      - stability testing of materials and products
      - qualification and maintenance of material and product suppliers
      - ensures complaints and recall procedures are current and implemented efficiently