AC 036COCH Kraków certifies Good Distribution Practice (GDP) for equipment used to transport and store pharmaceutical and temperature-sensitive products — under programme PR-06 and PCA accreditation AC 036 (80+ years of HVACR expertise).
Programme PR-06 (edition 9, 15.02.2024) sets the conditions for obtaining a GDP certificate for means of transport, thermally insulated containers and chambers, and accessory equipment that improve the quality of transport and storage under controlled or regulated temperature. Only isothermal equipment with refrigeration and/or heating capability can meet the regulatory expectations for product safety and quality.
The certification body operates under PN-EN ISO/IEC 17065 with PCA accreditation AC 036. The process follows programme type (N) per PN-EN ISO/IEC 17067: application review, agreement, evaluation of tests, independent review, decision and attestation (certificate). The reference document for evaluation is GDP PHARMA–03/2023 (COCH). A certificate may cover the full scope of that document or a scope limited to temperature-distribution mapping.
For transport units, a valid ATP certificate is required. Each specimen with a factory (identification) number receives a separate certificate valid for 3 years. Legal and normative bases listed in PR-06 include Pharmaceutical Law, the Minister of Health GDP regulation, EU Guidelines 2013/C 343/01, WHO guidance on refrigerated road vehicles and the ATP Agreement.
Useful external references: European Commission — GDP · EMA — Good Distribution Practice.
Scope from programme PR-06: transport units (with ATP), insulated containers and chambers, and accessory equipment — one certificate per serial-numbered unit.
Refrigerated or isothermal means of transport that meet ATP requirements and the PR-06 / GDP PHARMA–03/2023 reference document for the scope requested in the application.
Thermally insulated containers and chambers used to transport and/or store pharmaceutical and temperature-sensitive products under controlled or regulated temperature.
Additional equipment elements of the transport unit that improve transport quality — including isothermal (thermal insulation) covers — within the certified scope.
Each specimen marked with a factory (or identification) number receives a separate GDP certificate. Validity is 3 years from the grant date.
Programme PR-06 (type N per PN-EN ISO/IEC 17067): from application review through evaluation to the 3-year certificate.
Overview of the main stages — hover or tap a step for details.
1Application review and registration
Submit the GDP certification or re-certification application with product identification data (e.g. manufacturer plate / serial numbers for the unit and refrigeration unit), normative documents, requested scope and client details. We check completeness and register the application.
Practical steps before submitting the PJCW-10 application and the dates that matter across the certificate lifecycle.
Most delays in GDP certification come from formalities that can be settled before the application is filed: an expiring ATP certificate, missing identification data for the unit, or an undecided certification scope. The steps below follow programme PR-06 and the reference document GDP PHARMA–03/2023.
Fees on request, application forms, programme PDF and related services for ATP and temperature mapping.
Download the GDP application, programme PR-06 and related declarations, or submit the application online. Completed documents should be sent to certyfikacja@coch.pl.
Send completed documents to certyfikacja@coch.pl
The fee schedule for certification is approved by the Director of COCH and is available from the Certification Department. Please send your inquiry to: certyfikacja@coch.pl
Certification may end at the client’s request or by decision of the body if there is no information about continuing within 6 months. Misuse of the certificate or mark may lead to suspension or withdrawal — see programme PR-06.
Information on the complaints and appeals procedure is available here: Complaints and appeals
Not sure whether you need full-scope GDP, mapping-only certification or an ATP renewal first? Call or email the certification office.
Obtain or renew the ATP certificate required for GDP certification of transport units.
Temperature-distribution mapping of cargo space for pharmaceutical and sensitive goods.
Thermal testing of insulated containers used in temperature-controlled logistics.
ATP prerequisite, 3-year validity, mapping scope, fees, how to start under PR-06 — and the rights and obligations of certificate holders.
GDP certification under PR-06 is delivered by the COCH Product Certification Body — PCA AC 036, PN-EN ISO/IEC 17065.
PCA AC 036 · IAF MLA
Our specialists support clients through preparation, evaluation and certificate use. PCA accreditation underpins the reliability of GDP certificates issued for transport units, containers, chambers and accessory equipment.
Questions about PR-06 scope, ATP prerequisite, documents, quotation or next steps.
mgr Miłosz Gratkowski
Head of Certification Body
How to find us
Centralny Ośrodek Chłodnictwa „COCH”
ul. Juliusza Lea 116, 30-133 Kraków
Monday – Friday, 8:30 – 18:00
Entrance from Juliusza Lea Street. Parking available on site for clients.
Send an inquiry or call the certification office. We will advise on scope, ATP status, documents and next steps.
