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Food Safety Management System, FSMS (FSSC 22000) (Prerequisite Program…

- - - - Organisational WSH Policy
      - Preparation
        
        Form Risk Management Team
        
        Gather relevant information
        
        Workplace layout plan
        
        Process or workflow chart
        
        List of chemicals, machinery or tools used
        
        Record of past incidents and accidents
        
        Relevant Legislation, CPs or specifications
        
        https://www.tradenet.gov.sg/tradenet/portlets/search/searchHSCA/searchInitHSCA.do
        
        Observations and interviews
        
        WSH Inpsection records
        
        Health and safety audit reports
        
        Details of existing controls
        
        Feedbacks
        
        SWPs (Safe Work Procedures)
        
        Safety Data Sheet, Manufacturer manual
        
        Medical conditions of workers at workplace
        
        NEA- Hazardous permit license
        
        SCDP- Flammable storage license
        
        SPF- Explosive precusor license
        
        CNB- form to fill for drug precusor
        
        https://www.caas.gov.sg/operations-safety/carriage-of-dangerous-goods
        
        Identify tasks of each process in sequential order
      - Risk Assessment
        
        Hazard Identification
        
        Fire
        
        Ergonomic
        
        Electrical
        
        Physical
        
        Mechanical
        
        Chemical
        
        Biological
        
        Psycho-social
        
        Risk Evaluation (5 x 5 matrix)
        
        Severity
        
        Likelihood
        
        Based on Code of Practices
        
        Risk Priority Number (RPN)
        
        Risk Control
        
        Elimination
        
        Substitution
        
        Engineering Controls
        
        Isolation
        
        Containment
        
        Limitation
        
        Administrative Measures
        
        Maintenance Schedule
        
        Rotation of team
        
        Monitoring of Hazard (ongoing if severity cannot be reduced further)
        
        Personal Protective Equipment
      - Implementation
        
        Obtain Employer or Management Approval
        
        Implement Control Measures
        
        Communicate the hazards identified and their controls (Safe Work Procedure ;SWP)
        
        Audit or regular inspection
      - Record Keeping
        
        Must be available upon request
        
        Kept for at least three years
      - Review
        
        Review of RA on a regular basis (Risk Register)
- - - - Identify likely degradation products, establish degradation pathway, validate stability indicating power of analytical procedures used
      - Accelerated study on 1 batch of drug substance (10 degree increase and 10 %RH increase)
      - Testing to evaluate drug substance susceptibility to hydrolysis across a range of pH in solution or suspension
      - Photostability testing
      - Intermediate study on 3 batches of drug substance (pilot scale by same synthetic route, method of manufacture similar to production batches)
      - drug substance packaging proposed for storage and distribution
      - Physical, chemical, biological, microbiological attributes
      - Testing frequency of every 3 months over first year, every 6 months over second year
      - Storage condition and retest date to be established for label
      - Other condition 5+-3degree(refrigerator), and -20+-5 degree (freezer)
      - Significant change is OOS
    - - Performed on each individual strength and container size of the drug product
      - Batches of drug products should be manufactured using different batches of drug substances
      - Water loss based on container
      - Physical, chemical, biological, microbiological attributes
      - Expiration date to be displayed on product label
      - Significant change is
        1)5% assay change or out of potency requirement
        2) Related Imps OOS
        3)Failure in physical attributes (color, caking), pH, dissolution form (tablet, capsules, solution, cream)
      - Similar to drug substance. Testing frequency of every 3 months over first year, every 6 months over second year
      - mixed with excipient
  - - - Assay test for drug substance/products
      - Imp limit test
      - Imp quantiative test
      - identification test
    - - Specificity
      - Linearity
        
        Minimum of 5 concentrations
        
        80-110%
        
        regression line by method of least square
      - Accuracy
        
        9 determinations over a minimum of 3 concentrations (eg. 3 concentrations/3 replicates each)
      - Precision
        
        Repeatability
        
        Intermediate Precision (days, analysts, equipments)
        
        Reproducibility (interlab trials)
        
        minimum of 9 determination (eg. 3 concentrations/3 replicates each)
      - Detection Limit
        
        3:1 signal to noise ratio of samples with known low analyte concnentration
      - Quantitation Limit
        
        10:1 signal to noise ratio of samples with known low analyte concnentration
- - - - Meningitis
      - mortality rate >50%
    - - skin infections
      - Food posioning
      - Toxic shock syndrome