Industry news
Indonesia's BPOM sets new rules for assessing GMP at overseas drug plants
Indonesia's Food and Drug Authority (BPOM) Regulation No. 33 of 2025 took effect on 31 December 2025. BPOM's head signed it on 29 December 2025. It sets how BPOM assesses compliance with Indonesian good manufacturing practice (CPOB) at imported drug manufacturing facilities.
By ZY Cleanroom · Updated · Sources at the end of the page
What changed
Source for this section is the regulation text as republished by Pasal.id, read with BPOM's KlikCPOB FAQ.
The regulation replaces BPOM Regulation No. 7 of 2019. It lets BPOM use three methods, alone or together. They are document assessment, desktop inspection and on-site inspection. A desktop inspection is a document-based review done remotely. A compliance decision is valid for up to two years while the facility keeps operating and meets the requirements.
Existing compliance decisions stay valid until they expire. Applications already in process continue under the 2019 rule.
What the application file must hold
Article 6(4) lists the documents. They include a valid GMP certificate, the latest full inspection report, no more than two years old, and a Site Master File with an effective date no more than one year old. Evidence of corrective actions is needed if there were critical or major findings. A layout of the production rooms is also on the list.
BPOM may also assess a plant again after its products are on sale. Read the official text before you quote an article.
What a facility owner should check next
If your plant abroad supplies Indonesia, ask your Indonesian licence holder which assessment route applies to you. Then check your records. A desktop reviewer sees documents, not rooms.
Dated drawings, classification reports, qualification records and change records make that review easier. Check that your Site Master File matches the rooms as built. If you are planning a cleanroom, you can send ZY Cleanroom your room list.
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
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