What is GDP?

  • Knowing the supply chain, knowing the suppliers (of raw material and/or an active ingredient) right from the farm/abattoir, where it is sourced, extracted, purified and then made into the pharmaceutical substance that goes into a patient
  • It also includes the manufacturing facility, warehouses (wholesaler, local/distribution and retail), storage units, transport vehicles among other things
  • Traceability for the handling of the product (e.g., storage conditions, stability, who has access to every raw material/active ingredient/product, etc.)
  • Knowing the local regulations for the market (e.g., EMA for EU level and Läkemedelsverket for Sweden)
  • Using Quality Risk Management (QRM risk assessment tools) and achieving quality at every step of the way
  • Data security is very important complying with EU GMP and GDPR regulations

What should companies do?

  • High expectations on pharma supply chain and being updated on the latest regulations
  • Documentation wherever it is required and/or recommended
  • Assess what regulators require and comply accordingly based on the risk assessment
  • Every regulatory authority interprets the same regulations differently. Companies must take that into account depending on the market
  • Maintain logs of everyone who goes in and out of every facility in the supply chain to backtrack in case of errors
  • Knowing the market and assessing the bureaucratic load. Despite this, keep the patient in mind to have a pragmatic approach
  • Around 49 regulatory authorities are a part of Pharmaceutical Inspection Cooperation Scheme (PIC/S). They all follow EU GDP guidelines making it easy to keep track of what to document