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QA + QC (Quality Unit), Proposed shelf life - Coggle Diagram

- - - - Minimum pilot scale (representative of production)
        
        Can be smaller than usual batch as long as same equipment is used
      - At least 3 primary batches to ensure batch uniformity
    - - Performed initially
        
        Every 3 months for 1st year
        
        Every 6 months for 2nd year
        
        Annually thereafter
    - - Testing is done under normal storage/exaggerated conditions (stress or accelerated stability testing)
      - Test sensitivity to moisture + light as well unless packaging can prevent deterioration
    - - Accuracy, sensitivity, specificity, and reproducibility of test methods must be established and documented
      - Must include stability indicating test which will distinguish the active ingredient from any degradation products and be able to make a reliable estimate of the quantity of any degradate
  - - - If data does not cover the proposed shelf life at time of interval
    - - Long term
        
        25 ± 2°C at 40% ± 5% RH
        or
        30 ± 2°C at 35% ± 5% RH
        
        If 2nd option is the long-term condition, there will be no intermediate condition
        
        Min. time period covered by data at time of submission: 12 months
      - Intermediate
        
        30 ± 2°C at 65% ± 5% RH
        
        Min. time period covered by data at time of submission: 6 months
      - Advanced
        
        40 ± 2°C at not more than 25% RH
        
        Min. time period covered by data at time of submission: 6 months
    - - Long-term
        
        5 ± 3°C
        
        12 months
      - Accelerated
        
        25 ± 2°C at 60% ± 5% RH
        
        6 months
      - Proposed shelf life
        
        No significant change during accelerated conditions
        
        Y = 1.5X but not more than X + 6 months
        
        Significant changes during accelerated 6 months studies
        
        Proposed shelf life will be based on data from long-term storage condition
    - - Long-term
        
        -20 ± 5°C
        
        12 months
      - Proposed shelf life
        
        Cannot be extrapolated, based on data from long-term storage condition
  - - - a) Initial
        b) 3 months
        c) 6 months
        d) 9 months
        e) 1 year
        f) 1.5 years
        g) 2 years
        h) 3 years
        i) 4 years
        j) 5 years
  - - - applied to studies with multiple strengths of identical formulations and container closure system
        
        Capsules of different strengths made with different fill sizes from the same powder blend
        
        Tablets of different strengths manufactured by compressing varying amounts of the same granulation
      - in cases of different excipients are used among strengths bracketing should not be used
  - - - where different excipients are used
      - different strengths where the relative drug substance and excipients change
      - different container closure system
- - - - Identity
      - Strength
      - Absence of objectionable microorganisms (when necessary)
  - - - written procedures
        
        Method of sampling
        
        no. of units per batch to be tested
      - acceptance criteria
  - - - Contains method published by the association of offical analytical chemist
        
        are recognised reference methods
      - Consists of a series of specifications, test procedures and acceptance criteria for each drug listed
- - - - results of examination should be recorded
- - - - Quality assurance unit
      - Maintenance and calibration of equipment
      - Reagents and solutions
  - - - Identity
      - Concentration
      - Storage requirements
      - Expiration date
- - - - Regulatory support available
      - Supplier's quality system
      - Service
  - - - Entrance meeting
        
        3.Fieldwork
        
        4.Exit meeting
        
        5.Reporting
        
        6.Follow-up