When foreign importers, license holders, and quality managers face a PerBPOM 27/2025 Facility Audit, they often expect a straightforward compliance check against the published rules. In our experience, the written standards are only a baseline. What decides the outcome is how a verifier applies them to a specific facility and file.
This article is written for regulatory affairs leads and quality managers operating across the drug, health supplement, quasi-drug, cosmetic, and processed food sectors. While your team might prepare a complete file based on the regulation text, a verifier’s practical interpretation can still turn a step you assumed was compliant into a CAPA finding.
We saw this firsthand in a 2026 BBPOM Jakarta facility inspection, where a temperature mapping protocol that our team judged consistent with the CAPA point still left the finding open at the first evaluation. This article walks through that case, explains what PerBPOM 27/2025 covers, and shows where a verifier can read a requirement differently from the written rule. It is one case, not a checklist.
What Is PerBPOM 27/2025 and Who Faces a Facility Audit?
PerBPOM 27/2025 is Peraturan Badan Pengawas Obat dan Makanan Nomor 27 Tahun 2025, the BPOM regulation setting business and product standards under risk-based licensing for drugs, herbal medicines, supplements, quasi-drugs, cosmetics and processed food.
Its full title is Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Subsektor Obat dan Makanan. It implements Article 5 paragraph (7) of Peraturan Pemerintah (PP) No. 28/2025, revokes PerBPOM No. 10/2021, and took effect on 3 October 2025.
BPOM groups the standards into three areas: drugs and drug ingredients; herbal medicines, supplements, quasi-drugs and cosmetics; and processed food. Each covers marketing authorization, good production and distribution certification, advertisement approval and clinical and preclinical trial rules, all submitted electronically through OSS.
| Group under PerBPOM 27/2025 | Products | Good practice certification linked to the facility |
|---|---|---|
| Drugs and drug ingredients | Pharmaceuticals and active ingredients | CPOB for production; CDOB for distribution |
| Herbal medicines, supplements, quasi-drugs, cosmetics | Obat Bahan Alam (OBA), health supplements, quasi-drugs, cosmetics | CPOTB for traditional medicine production; CPKB for cosmetics |
| Processed food | Packaged food and beverages | IP-CPPOB |
Source: BPOM regulation page for PerBPOM 27/2025. Simplified for orientation; confirm the exact certificate for your activity against the regulation annex.
PerBPOM 27/2025 Facility Audit: The Core Answer
A PerBPOM 27/2025 Facility Audit is BPOM’s verification that a business’s premises, storage conditions, equipment, records and personnel meet the standard for its licensed activity. In our experience, it runs in three stages: document evaluation, facility verification and corrective action.
Stage 1: Document Evaluation After OSS Submission
Once your file is evaluated in OSS, BBPOM may ask for more evidence before scheduling anything. In our 2026 case at BBPOM Jakarta, the office requested 27 additional documents on 5 March, before an audit date existed.
In our experience, teams that assume the OSS upload is the full dossier lose their first weeks here. We treat this evaluation as the first round of the audit, handled on paper rather than on site.
Stage 2: Facility Verification
This is where storage and operating conditions are examined against the standard. In our experience, importers of traditional medicine and supplements face close questions on warehouse temperature control, including how monitoring devices are placed and whether their calibration can be evidenced.
Stage 3: Corrective Action (CAPA)
CAPA stands for Corrective and Preventive Action. BBPOM lists findings and the business answers each with evidence.
A Real PerBPOM 27/2025 Facility Audit Case at BBPOM Jakarta
The table summarizes one 2026 audit PRI supported for an importer of herbal medicine and health supplements. It is a single case, not a BBPOM standard timeline, and every office and verifier can behave differently.
| 2026 date | What happened | What it taught us |
|---|---|---|
| 5 March | After OSS evaluation, BBPOM requested 27 additional documents before scheduling the audit. | Document evaluation is a gate, not a formality. |
| 27 March | CAPA request issued. Sent by email reply. | Format instructions are part of compliance. |
| 18 April | First evaluation left the warehouse temperature mapping finding open. | A correct protocol can still miss the verifier’s reading. |
| 13 May | CAPA closure letter issued. | About 10 weeks from the 5 March document request to closure, with one correction round. |
The Temperature Mapping Finding
At the first evaluation, our team judged the mapping protocol consistent with the CAPA point. BBPOM still asked for the hottest point to be set from the actual maximum temperature recorded, not an average, plus calibration certificates for every monitoring device.
That is the practical lesson of this case. The protocol did not match how this verifier read the requirement, and rereading the regulation alone may not have revealed that gap.
Why PerBPOM 27/2025 Facility Audit Findings Differ Between Verifiers
The regulation sets the standard, but a person applies it. In our experience, two verifiers can read the same clause and request different evidence, so the outcome of one audit rarely transfers cleanly to another office or round.
Our practice is to confirm the interpretation and the submission route directly with BPOM, face to face, before drafting any technical step. A short meeting before the protocol is written costs less than a second correction round.
This is also why we avoid publishing a universal checklist. A list copied from one audit may be right for one office and incomplete for another, and acting on it alone can leave a finding open.
Decision Path: Does a PerBPOM 27/2025 Facility Audit Apply to You?
- Is your product a medical device or IVD? If yes, the Kemenkes pathway applies, covered in the medical device section below. If not, continue.
- Is it a drug, herbal medicine, supplement, quasi-drug, cosmetic or processed food? If yes, PerBPOM 27/2025 is your reference regulation.
- Do you produce, import or distribute? Your role decides which good practice certification and facility standard is relevant.
- Is the product category itself unclear? Resolve it first. See our article on Product Category Determination.
BPOM Facility Audit Requirements for Importers, Distributors and Manufacturers
BPOM facility audit requirements depend on the activity you license. Producers are assessed against good production practice certification and distributors against good distribution practice. In our experience, importers are judged on the readiness of their storage and records.
For cosmetic factories, Peraturan BPOM Nomor 8 Tahun 2026 tentang Sertifikasi Cara Pembuatan Kosmetik yang Baik (CPKB) was signed on 21 April 2026 and took effect on 29 April 2026, replacing PerBPOM No. 33/2021. See our guide to CPKB certification traps.
Cosmetic importers also need a technical person in charge before facility inspection under Peraturan BPOM Nomor 21 Tahun 2022 tentang Tata Cara Pengajuan Notifikasi Kosmetika. We explain this in Technical Person in Charge BPOM. For the registration side, see our Cosmetic Product Registration service.
Importers of supplements and herbal medicines can see how facility readiness connects to registration in our Health Supplements Registration service and our BPOM certification guide. Foreign brand owners that need a local license holder can see our License Holder Service in Indonesia.
Medical Device Registration in Indonesia: Where PerBPOM 27/2025 Stops
Medical device registration in Indonesia does not run through PerBPOM 27/2025. The regulation covers drugs, herbal medicines, supplements, quasi-drugs, cosmetics and processed food. Medical devices and IVDs are authorized by the Ministry of Health (Kemenkes), so a BPOM audit plan cannot simply be reused.
The JDIH Kemenkes record for Permenkes No. 62/2017 shows it as revoked by Permenkes No. 5 Tahun 2026 tentang Perbekalan Kesehatan. The 2026 regulation covers device market authorization (izin edar), so guidance written under the 2017 rule may be out of date. Confirm the current rule before relying on older guidance.
For the device route, read our comparison of IVD and medical device registration and our Medical Device and IVD Registration service. Facility and distribution expectations follow Kemenkes rules and should be planned separately.
How to Prepare for a PerBPOM 27/2025 Facility Audit
The points below reflect what our team reviews with clients before an audit. They are orientation, not a substitute for case-specific review, because the right evidence depends on your category, your office and your verifier.
- Confirm the verifier’s interpretation early, ideally in person, before writing technical protocols.
- Treat the OSS evaluation as the first audit round and expect further document requests.
- Read format instructions in correction requests literally, including file type and how evidence is attached.
- Check how the verifier defines each measurement, such as actual maximum temperature versus an average.
- Keep calibration certificates for monitoring devices available, and build time for at least one correction round.
Each point sounds simple. Applying it to a specific warehouse, product mix and BBPOM office is where mistakes appear, and where an early review can save the most time.
Key Terms and Acronyms Used in This Article
- BPOM: Badan Pengawas Obat dan Makanan, Indonesia’s National Agency of Drug and Food Control.
- BBPOM: Balai Besar Pengawas Obat dan Makanan, a BPOM regional main office such as BBPOM Jakarta.
- PerBPOM: Peraturan Badan Pengawas Obat dan Makanan, a BPOM regulation.
- PP: Peraturan Pemerintah, a Government Regulation.
- Permenkes: Peraturan Menteri Kesehatan, a Minister of Health Regulation.
- Kemenkes: Kementerian Kesehatan, the Ministry of Health.
- OSS: Online Single Submission, Indonesia’s national business licensing system.
- CAPA: Corrective and Preventive Action, the correction process after audit findings.
- CPOB: Cara Pembuatan Obat yang Baik, Good Manufacturing Practice for drugs.
- CPOTB: Cara Pembuatan Obat Tradisional yang Baik, Good Manufacturing Practice for traditional medicine.
- CPKB: Cara Pembuatan Kosmetik yang Baik, Good Manufacturing Practice for cosmetics.
- CDOB: Cara Distribusi Obat yang Baik, Good Distribution Practice for drugs.
- IP-CPPOB: Izin Penerapan Cara Produksi Pangan Olahan yang Baik, the good production practice approval for processed food.
- OBA: Obat Bahan Alam, herbal or natural-ingredient medicine.
- JDIH: Jaringan Dokumentasi dan Informasi Hukum, the national legal documentation network.
- Verifier: the BPOM officer who evaluates documents and facilities during an audit.
Limits of This Guidance
This article explains the scope of PerBPOM 27/2025 and shares one case. It does not set a standard BBPOM timeline, list every audit requirement, or replace a review of your own file. Interpretations change, so confirm current rules before acting.
Conclusion: Walk Into Your Audit Prepared
Delays in a PerBPOM 27/2025 Facility Audit are not always avoidable, but they are easier to plan for. In the case above, the gap was not in our reading of the regulation but in how the verifier applied one requirement. Confirming that interpretation early, and allowing time for a correction round, is the most practical lesson we can offer.
Product Registration Indonesia supports importers, brand owners, and quality managers before and during BPOM facility audits. Our team can help with initial document reviews, warehouse compliance checks, direct BBPOM communication and CAPA resolution, drawing on cases like the one above. Outcomes and timelines depend on the verifier and the file, but an early review can reduce avoidable corrections.
Ready to Navigate Your PerBPOM 27/2025 Audit with Confidence?
Whether you are preparing a new facility inspection or looking to resolve open CAPA findings across the drug, health supplement, cosmetic, or food sectors, we are here to help you bridge the gap between regulatory text and verifier expectations.
Fill out the contact form below to book a facility audit readiness consultation with our regulatory team. Let us review your compliance roadmap and help you move through the BPOM audit process with a clearer view of what to expect.
