Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

• be of consistent high quality
• be appropriate to their intended use
• meet the requirements of the marketing authorisation (MA) or product specification

Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.

Organisations that may have to comply with good manufacturing practice (GMP) and/or good distribution practice (GDP) include:

• manufacturer licence holders
• wholesale dealer licence holders
• blood establishment authorisation holders
• non-UK sites employed by UK MA holders

The Medicines and Healthcare products Regulatory Agency (MHRA) carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically based on risk assessments. Overseas manufacturing sites are also inspected.