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

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