[ HOW-TO GUIDE ]

How to Run One Site for Several GMP Regulators

Meet the shared GMP standard once and each market’s legal differences on top, so any of the site’s regulators can inspect it on any day.

What a how-to is not

A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.

A site that supplies the EU, the US, Canada, Japan and Thailand answers to several inspectorates. Most of them participate in PIC/S and inspect to a common GMP standard, so the quality system can be built once. What differs is national law: who releases a batch, which licences or clearances are needed, and how long records are kept. This sequence builds the common core and then layers each market’s requirements on it.

WORK THROUGH THESE STEPS IN THE TEMPLATE
Inspection Readiness Plan
Each step below has a place in SPEQ’s structured, regulator-aligned template for this procedure. Open the template →
THE STEPS
  1. 1

    List every market and its authority

    For each product, list the markets supplied, the authority that licenses or inspects the site for each, and whether that authority participates in PIC/S. Record the legal text each one applies — EU Directive (EU) 2017/1572 and EudraLex Volume 4, 21 CFR 210 and 211, Canada’s Part C Division 2, Japan’s GMP and GQP ordinances, Thailand’s Drugs Act licences.

  2. 2

    Build the quality system to the common standard

    Use the PIC/S and EU GMP Guide as the core, with the PI recommendation documents for the topics they cover, and map US requirements onto it. One deviation, change control and CAPA system serving every market is easier to defend than parallel systems.

  3. 3

    Map the release role for each market

    Write down who releases a batch for each market: the qualified person in the EU, the quality control department head under each Canadian licensee, the Japanese marketing authorisation holder’s market release under GQP, the US quality unit. Make the site’s batch disposition produce the evidence each of them needs.

  4. 4

    Take the longest record-retention period

    Collect each market’s retention rule — for example, one year after expiry for Canadian GMP records, and five years or more under Japan’s GQP depending on the product — and set the site’s retention to the longest applicable period, by product.

  5. 5

    Keep market-specific licences and clearances current

    Track each licence, registration and clearance with its renewal date, such as Thai GMP Clearance for an overseas site supplying Thailand. A lapse stops supply to that market even if the site’s GMP is unchanged.

  6. 6

    Host every inspectorate from one procedure

    Use one inspection-hosting procedure with a section for each authority’s practices, and keep one log of every inspection, finding and commitment across all of them, so a commitment made to one regulator is visible to the team facing the next.

COMMON PITFALLS
  • !Assuming PIC/S participation means one authority accepts another’s inspection; recognition depends on separate agreements or reliance policies.
  • !A release procedure written for one market’s release role and applied unchanged to the others.
  • !Record retention set to one market’s rule and short for another’s.
  • !Commitments made to one inspectorate that the team facing the next one does not know about.
REGULATORY BASIS
GO DEEPER

How to Run One Site for Several GMP Regulators: frequently asked questions

Common questions on run one site for several gmp regulators.

Can one quality system satisfy several GMP regulators?

Largely, because most major authorities participate in PIC/S and apply a GMP standard aligned with the EU GMP Guide. National law still adds market-specific requirements on release, licensing and record retention.

Does an FDA inspection count for other regulators?

Not automatically. PIC/S participation does not by itself create mutual recognition; whether another authority relies on an FDA inspection depends on its own agreements and policies.

Which record-retention period should the site use?

The longest that applies to each product across the markets it is supplied to, documented by product, so that no market’s requirement is short.

RELATED HOW-TO GUIDES
All 127 guides →

WHERE NEXT

  1. DO ITOpen the Inspection Readiness Plan template →The structure these steps fill in.
  2. UNDERSTAND ITInternational GMP Regulators and PIC/S →The principles behind the procedure.
  3. ALL GUIDESBrowse all 127 how-to guides →

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