gdp and gsp

gdp and gsp in the philippines

  • good distribution practices — WHO annex 5

  • good storage practices — WHO annex 9

good distribution practices

  1. all parties have a responsibility to ensure that the quality of pharmaceutical product and the integrity of the distribution chain is maintained

    1. credible distributors

    2. trained personnel (product handling, product security, product identification, detection of counterfeit)

  2. regulation of distribution process

    1. may distribute within a country only if marketing authorization has been granted

    2. obtain supplies from legitimate suppliers

  3. develop system for traceability of pharmaceutical products

  4. vehicles and equipment should be suitable for their purpose

    1. capacity, temperature, humidity, clean and dry

    2. equipment for monitoring conditions: calibrated

    3. gps, engine-kill button, anti-theft

  5. vehicle loaded on a “first-out/last-in basis”

  6. repackaging and relabeling of pharmaceutical products should be limited

    1. presents risk to safety and security of supply chain

  7. protect supply chain against entry of counterfeit products

    1. separate counterfeit

    2. sale and

  8. distribution records should contain at least the following information:

    1. date

    2. name of pharmaceutical product

    3. quantity received of supplied

    4. name and address of supplier

good storage practices

  1. storage areas

    • prevent unauthorized access

    • clean, dry, proper lighting, temperature, RH control, ventilation, air filtration, differential pressure

    • sufficient capacity for segregation of materials and products (starting and packaging materials, intermediates, bulk and finished products, products in quarantine, released, rejected, returned or recalled products, highly active, radioactive, and narcotic products)

    • receiving and dispatch bays should protect materials and products from the weather

    • “First expired/first out” (FEFO) principle should be followed

  2. storage requirements

    • documentation: written instructions and records

      • storage conditions, cleaning, deliveries, receipts, etc.

    • labelling

      • material, batch number, expiry date, storage conditions, reference to pharmacopoeia

    • suitable containers (non-reactive)

    • all deliveries checked against the purchase order (physically verified and sampled)

    • quarantined until approved for use/release

    • stock rotation and control

      • compare actual and recorded stocks