⭐ 3.2 GMP vs. GDP

What is GMP?

Good manufacturing practices (GMP) are the practices required to conform to the guidelines recommended by agencies that control authorization and licensing for the manufacture and sale of active pharmaceutical and drug products. These guidelines provide minimum requirements that a pharmaceutical product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good manufacturing practices are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption.

What is GDP?

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

Compliance with GDP ensures that:

• medicines in the supply chain are authorised in accordance legislation

• medicines are stored in the right conditions at all times, including during transportation

• contamination by or of other products is avoided

• an adequate turnover of stored medicines takes place;

• the right products reach the right addressee within a satisfactory time period.

The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.

GDP also applies to the sourcing, storage and transportation of drug substances and other ingredients used in the production of the medicines.