GMP and GDP quality systems

GMP and GDP in plain terms

Good Manufacturing Practice (GMP) covers how a medicine is made, tested and released. Good Distribution Practice (GDP) covers how it is stored, moved and supplied once it leaves the manufacturer. In the UK both are enforced by the MHRA, and both rest on the same idea: a documented quality system that controls risk and proves it.

For cannabinoid businesses the two often meet in one supply chain. A product made under GMP overseas is imported, stored and distributed under GDP in the UK, usually through licensed third parties.

What a working QMS looks like

A quality management system is not a folder of SOPs. It is a set of connected processes with clear owners: document control, training, deviations, CAPA, change control, complaints, recalls, supplier and customer qualification, self inspection and management review.

Each process should feed the others. A deviation leads to a CAPA, the CAPA may trigger a change, the change updates an SOP, and the updated SOP drives retraining. Inspectors follow that thread, so it has to hold together.

SOPs and training

Write procedures for what people actually do, in the order they do it. Long, generic SOPs copied from another company are a common inspection finding because staff cannot follow them.

Training records should show that each person is trained on the current version of every procedure relevant to their role, before they carry out the task.

Deviations, CAPA and change control

Record deviations promptly, assess their impact on product quality, and find the root cause rather than stopping at human error. CAPAs should be specific, owned, dated and checked for effectiveness.

Change control should assess any change to premises, equipment, suppliers, processes or documents before it happens, not after. Unrecorded changes are one of the quickest ways to lose an inspector's confidence.

Suppliers, partners and quality agreements

Every supplier and service provider that can affect product quality needs to be qualified and kept under review. For GDP this includes checking that suppliers and customers hold the right licences.

Quality agreements should set out who is responsible for each activity, including release, storage, transport, complaints, deviations and recalls. Where several businesses share one supply chain, gaps between agreements are where problems hide.

Signs your system needs work

• SOPs that do not match what happens on the floor
• Deviations closed as human error with no real root cause
• CAPAs that stay open for months or are never checked for effectiveness
• Changes made without a change control record
• Suppliers or partners with no current qualification or quality agreement
• No self inspection programme, or findings that are never followed up