Frequently Asked Questions

Pre-market supervision is carried out in the context of Good Manufacturing Practice (GMP) Certification of Production Facilities for Drugs, Medicinal Materials, Biological Products and Special Facilities, including changes to production facilities. Meanwhile, post market surveillance of production facilities is carried out, among others, through periodic CPOB inspections with risk-based principles. The implementation of post market surveillance is carried out to ensure that CPOB is consistently fulfilled and implemented by the Pharmaceutical Industry. Inspections are also carried out if necessary in the context of tracing certain cases.

Follow-up on the results of supervision of production facilities is provided in accordance with BPOM Regulation No. 9 of 2024 Guidelines for Follow-Up on the Results of Supervision of Drugs, Medicinal Materials, Narcotics, Psychotropic Substances, Precursors, and Addictive Substances article 10 where follow-up includes technical guidance and administrative sanctions. Administrative sanctions include, among others: 

1. Warning;
2. a stern warning;
3. temporary suspension of activities;
4. temporary suspension of manufacturing activities of Drugs, Narcotics, Psychotropic Substances, and Precursors;
5. suspension of the CPOB Certificate;
6. revocation of the CPOB Certificate;
7. temporary ban on circulation and/or order for recall from circulation
8. destruction or reshipment/re-export order
9. temporary closure of access to business license applications.

Sanctions for revocation of the CPOB certificate are given if based on the results of supervision it has met the criteria for sanctioning the Revocation of the CPOB Certificate in accordance with BPOM Regulation No. 9 of 2024 Guidelines for Follow-Up on the Results of Supervision of Drugs, Medicinal Materials, Narcotics, Psychotropic, Precursors, and Addictive Substances. The revocation process will be facilitated through OSS and followed up by the authorized institution, namely BKPM, to revoke PB based on the proposal of business actors and K / L / D. Currently, BKPM can facilitate revocation based on the submission of an official letter from BPOM. Meanwhile, the process of revoking PB-UMKU through OSS including the CPOB Certificate is still in the development stage.

For industries that decide to stop manufacturing activities or return the valid CPOB certificate, they must submit a notification to BPOM. For CPOB certificates that are not renewed and/or returned, production facilities should submit information on the handling of equipment, facilities, and related materials. BPOM will then follow up with steps to ensure the implementation of facility closure, if based on risk management, direct assurance is needed to the production facility through local inspections.

1. Government Regulation no. 5 of 2021 concerning Implementation of Risk-Based Business Licensing with detailed information on Appendix A.
2. POM Agency Regulation Number 10 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Medicine and Food Sector with detailed requirements on Appendix A5.

CPOB certification/recertification/facility changes/addition of warehouse or secondary packaging outside the factory location is submitted via the Online Single Submission (OSS) system which is integrated with the CPOB e-certification system (e-ertification.pom.go.id). A tutorial on how to submit can be seen in the Public Services – Certification information.

The flow of applications for new certification/facility changes/addition of warehouse or secondary packaging outside the factory location is as follows:

1. Request for pre-certification document evaluation;
2. If based on the results of the pre-certification document evaluation it can proceed to the inspection stage, the pharmaceutical industry can submit applications through the OSS system which is integrated with e-certification;
3. Non-Tax State Revenue Payments (PNBP);
4. Implementation of inspections;
5. Approval and/or CAPA will be submitted via the e-ertification.pom.go.id system.

Complete application procedures can be accessed in the information Public Service – Certification and also listed on Public Service Standards Handbook.

Pre-certification documents need to be submitted before an inspection is carried out in the context of changes to production facilities/new CPOB certification/addition of warehouses or secondary packaging outside the factory location. Submission procedures and a list of pre-certification documents that need to be submitted can be seen in the information Public Service – Certification.

Further explanation regarding pre-certification documents for warehouse applications outside the factory location is listed in Public Service – Certification, as follows:

1. Application letter;  
2. Plan of the warehouse space outside the factory location that will be used;
3. Rental agreement (for rental warehouse);
4. Change control and QRM documents;
5. SOPs used in warehouses outside the factory location;
6. Work Permit for the Pharmacist in Charge of the Warehouse Outside the Factory Location;
7. Warehouse operator training results;
8. Warehouse APJ qualification documents including job description;
9. Warehouse APJ appointment letter;
10. Warehouse temperature mapping protocols and reports.

There is no time limit for submitting revised pre-certification document evaluation results. Resubmission can be done after the repair documents are available.

For the next application, you must submit it again via OSS, so you will get a new OSS permit ID. The OSS permit ID is only valid for 1 (one) application for each type of facility.

Documents uploaded to the CPOB e-certification system as stated in Appendix A5 POM Agency Regulation Number 10 of 2021. 

Regarding applications for new CPOB certification/changes in facilities/addition of warehouses or secondary packaging outside the factory location, if there are application documents that have been submitted at the time of the pre-certification application, then in the application letter you must also provide information regarding the submission date and medium for submitting the pre-certification documents.

In accordance with POM Agency Regulation Number 10 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Medicine and Food Sector – Appendix A5, the request for an extension of the CPOB Certificate is submitted no sooner than 6 (six) months before the certificate expires.

There is detailed information that needs to be submitted when applying for a certificate extension, namely:

1. The application letter includes the activities and production facility buildings whose certificates will be extended.
2. The list of changes since the last inspection includes the number and date of the proposed change, a description of the change, category, status and targets solution. If there are no changes, you are asked to make a signed statement on a stamp.
3. List of deviations since the last inspection (deviations batches and non-batches) includes deviation report number and date, deviation description, category, status and completion target. If there is no list of deviations, you are asked to make a statement signed on a stamp.
4. The PMP for the last period for the 3 (three) most widely produced products for each dosage form includes aspects contained in the 2018 CPOB Guidelines. 
   – If less than 3 (three) products are produced, the pharmaceutical industry is asked to submit a stamped statement stating that the number of products produced is less than 3 (three) products per dosage form, stating the name of the product.
   – If no products have been produced at the facility, the pharmaceutical industry is asked to submit a process validation protocol for the products to be produced, convey the reasons why production has not been carried out since the CPOB certificate was issued, and product development plans or future production plans.
5. Progress matrix Corrective Action and Preventive Action (CAPA) last inspection. If recertification is submitted after an inspection is carried out in the current year, the CAPA submitted is the CAPA for that year.

1. Change control;
2. Specifications for starting materials and finished products, master production documents, processing, cleaning and testing procedures related to the activities to be carried out;
3. Process Validation Protocol;
4. Cleaning Validation Protocol;
5. Product Analysis Method Validation Protocol and Report markers; 
6. Product Analysis Method Validation Protocol and Report;
7. Qualification of affected sterilizers (for sterile products).

Pelaksanaan transfer teknologi mengacu pada ketentuan berikut yang wajib dikaji secara bersama dan komprehensif:

1. Peraturan Badan Pengawas Obat dan Makanan Nomor 7 Tahun 2024 tentang Standar Cara Pembuatan Obat yang Baik.
2. Peraturan Badan Pengawas Obat dan Makanan Nomor 7 Tahun 2025 tentang Perubahan atas Peraturan Badan Pengawas Obat dan Makanan Nomor 7 Tahun 2024 tentang Standar Cara Pembuatan Obat yang Baik.
3. WHO Technical Report Series 1044 Annex 4 Guidelines on Technology Transfer in Pharmaceutical Manufacturing.

Pengajuan prasertifikasi CPOB yang wajib melampirkan dokumen transfer teknologi, yaitu:

1. Penambahan obat dengan sertifikat CPOB baru.
2. Penambahan fasilitas produksi dan/atau laboratorium pengujian.

Pada tahap ketiga, yaitu fase eksekusi. Pengajuan prasertifikasi CPOB dapat dilakukan setelah tersedia laporan validasi metode analisis, protokol validasi proses, dan protokol validasi pembersihan yang telah selesai dan disetujui oleh unit pengirim dan unit penerima.

Berikut dokumen transfer teknologi yang wajib dilampirkan:

1. Prosedur transfer teknologi
2. Protokol dan ringkasan laporan transfer teknologi mencakup hal berikut, namun tidak terbatas pada:
   a. ruang lingkup,
   b. nama dan alamat unit pengirim (sending unit) dan unit penerima (receiving unit),
   c. tanggung jawab tim transfer teknologi,
   d. analisis kesenjangan antara unit pengirim dan unit penerima, misal personel, bangunan, fasilitas, peralatan, instrumen, sarana penunjang, pembersihan, pengujian, dan kualifikasi dan validasi,
   e. kriteria keberterimaan tim transfer teknologi,
   f. jadwal,
   g. realisasi, dan
   h. kesiapan.
3. Informasi pengembangan produk:
   a. histori pengembangan produk;
   b. profil bahan awal dan bahan pengemas;
   c. spesifikasi dan justifikasi bahan;
   d. pengembangan formula;
   e. alur proses pembuatan;
   f. parameter proses kritis dan nonkritis beserta rentang;
   g. atribut kualitas kritis produk; dan
   h. ringkasan data stabilitas bahan awal, bahan kemas, dan produk jadi.
4. Catatan pelatihan personel hingga level operator/analis
5. Pengendalian perubahan berkaitan dengan pengembangan produk baru dan transfer teknologi

Pelaku usaha dapat mengakses dan mengisi formulir prasertifikasi melalui tautan Download untuk pengajuan sertifikasi baru, penambahan aktivitas, maupun perubahan fasilitas.

Sementara itu, untuk pengajuan gudang yang berlokasi di luar area pabrik, pelaku usaha dapat menggunakan formulir prasertifikasi khusus gudang di luar lokasi pabrik melalui tautan Download

Submissions are made electronically via the Online Single Submission (OSS) system which is integrated with the CPOB e-certification system (e-certification.pom.go.id).

Traditional Medicine, Cosmetics, Health Supplements, and Quasi Medicine

Requirements can be seen in Food and Drug Supervisory Agency Regulation Number 10 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Drug and Food Sector, section A.7 which can be accessed via jdih.pom.go.id

20 working days / supplies / commodities

The application for a fasber extension must be made at least 6 months before the validity period ends, and can be submitted simultaneously with the application for CPOB Recertification of facilities used to produce non-drugs.

FASBER approval is required for non-drug products whose monographs are not listed in the compendial but which are capable of being tested qualitatively and quantitatively.

Submission of applications is done via OSS.go.id which is integrated into the application e-certification.pom.go.id, The application tutorial can be watched via the NPP Drug Ditwasprod Youtube account here

All imported medicinal products (including biological products) will be registered and distributed in Indonesia. Especially for biological products, apart from production facilities drug products (DP), an assessment of compliance with CPOB requirements is also carried out on production facilities drug substance (DS).

Requirements for assessing the fulfillment of CPOB requirements for imported medicine manufacturing facilities can be seen in POM Agency Regulation No. 10 of 2021, as well as POM Agency Regulation No. 7 of 2019. which can be accessed via jdih.pom.go.id

No. Assessment of compliance with CPOB requirements for imported drug manufacturing facilities has several evaluation mechanisms:

1. assessment of Imported Medicine Registration documents regarding fulfillment of CPOB requirements;
2. Desktop Inspection;
3. Inspection of Imported Medicine Manufacturing Facilities
4. Evaluate local inspection CAPA

For imported drug production facilities that have been declared to meet CPOB requirements in the first stage of evaluation, there is no need to go through other evaluation mechanisms.

Meanwhile, if the imported drug production facilities do not meet CPOB requirements in the first stage, the evaluation will be escalated to the next stage.

The detailed timeline for each stage of the Assessment of Fulfillment of CPOB Requirements for Imported Medicine Manufacturing Facilities is stated in PerBPOM No. 7 of 2019, with a summary as follows:

1. The decision on the evaluation results of drug registration documents regarding fulfillment of CPOB requirements is submitted no later than 15 HK after the documents are declared complete 
2. Results decision Desktop Inspection submitted no later than 20 HK after the documents are declared complete 
3. Local Inspection Results are submitted no later than 22 HK after the inspection is completed 
4. The results of the local inspection CAPA evaluation are carried out no later than 30 HK after proof of PNBP payment is submitted

The deadline for submitting documents at each stage of the Assessment of Fulfillment of CPOB Requirements for Imported Medicine Manufacturing Facilities is stated in detail in PerBPOM No. 7 of 2019, with a summary as follows:

1. Evaluation of drug registration documents regarding compliance with CPOB requirements: there is no time limit for submitting documents
2. Desktop Inspection: complete documents submitted no later than 80HK 
3. Local Inspection: 

• 80 HK after a local inspection notification letter is issued based on the Assessment of Imported Drug Registration Documents Regarding Fulfillment of CPOB Requirements. 
• 30 HK after notification that the applicant does not meet the deadline for submitting Desktop Inspection Documents. 
• 10 HK after a local inspection notification letter is issued based on Desktop Inspection 

Before submitting an application, ensure that the Criteria Type for Imported Medicines has been selected. The process steps are as follows: 

1. Enter the company profile menu 
2. Select the factory/warehouse type data tab 
3. Fill in the form according to the fields by selecting the type of criteria for Imported Medicines 
4. Complete the name of the person in charge, etc., then click save data

Producers can send documents directly to the POM Agency without going through the registrar accompanied by documents Quality Assurance Agreement (QAA) between producers and registrants. Applicants still submit applications for assessment of compliance with CPOB requirements through the e-certification application by attaching proof of document delivery from the manufacturer.

Documents are sent via email ditwasprod@pom.go.id and/or yanblik.wasprod@gmail.com

Products with the same name but different strengths can be requested in one application. 

Meanwhile, for other products, for example products with different ingredients, different dosage forms, etc., submissions are made separately for each product.

Submissions for assessing the fulfillment of CPOB requirements for imported drug manufacturing facilities involving more than 1 manufacturing site are still carried out through the e-certification system in 1 (one) submission (1 No. Aju) by including all names and addresses of drug manufacturing sites, including the activities carried out at each site in the application letter.

Yes. The results of the evaluation of CPOB compliance for imported drug facilities in the form of registration recommendations are issued per product so that they only apply to the product registration process listed in the letter. However, the registration recommendation letter is valid for 2 years, so the results of the previous assessment can be used as a reference in conducting assessments for other products within a period of 2 years, as long as the product is produced in the same production facility. However, decisions regarding the registration of other products will still be subject to risk review by the POM Agency in accordance with the latest evidence of CPOB compliance from the manufacturer's site, and the results will be published in a separate letter.

In accordance with POM Regulation No. 7 of 2019, proof of registration is one of the complete documents needed to assess compliance with CPOB requirements. However, there are several cases at the pre-registration stage where proof of SMF submission is requested. In this case, the application can be made before the registration stage, so that proof of submission in e-certification can be used to complete supporting documents for the registration process. Considering that each application will first be checked for completeness, including proof of registration, the assessment will still begin until the registered product enters the registration stage

In general, documents are required to be at least in English, with clearly legible image resolution, especially facility layouts, diagrams or other schematics contained in the document.

Regarding problems such as not being able to download the Registration Recommendation Letter, or PNBP has been paid but the status on the application is not correct, you can contact the CPOB e-Certification Application Hotline via WA No. 0898-5321-216

Before the evaluation process, an initial selection/screening is first carried out to ensure the completeness and suitability of the CPOB assessment documents for imported drugs being submitted. Files are accepted (declared complete) if the documents submitted meet all the requirements based on the checklist.
Files are rejected if one or more of the requirements on the checklist are not met. The screening results are conveyed to applicants via comments listed on the e-certification application. Once declared complete, the application can continue to be evaluated

Dokumen yang perlu disampaikan pada penilaian pemenuhan persyaratan CPOB fasilitas pemuatan obat impor dapat dilihat pada Peraturan Badan POM No. 33 tahun 2025 tentang Penilaian Pemenuhan Persyaratan Cara Pembuatan Obat yang Baik Terhadap fasilitas Pembuatan Obat Impor, yang dapat diakses melalui jdih.pom.go.id.

Timeline setiap tahapan Penilaian Pemenuhan Persyaratan CPOB Fasilitas Pembuatan Obat Impor secara rinci tercantum dalam PerBPOM No. 33 Tahun 2025, dengan ringkasan sbb:

1. Keputusan hasil verifikasi permohonan penilaian dokumen paling lama 3 HK dengan mekanisme time to respond.
2. Keputusan hasil evaluasi disampaikan dalam jangka waktu paling lama 15 HK sejak permohonan dinyatakan lengkap.
3. Keputusan hasil verifikasi permohonan penilaian Dokumen Inspeksi paling lama 3 HK dengan mekanisme time to respond.
4. Keputusan terhadap hasil Desktop Inspection disampaikan dalam jangka waktu paling lama 20 HK sejak permohonan Desktop Inspection dinyatakan lengkap.
5. Hasil inspeksi setempat disampaikan dalam jangka waktu paling lama 22 HK sejak inspeksi selesai dilakukan.
6. Hasil evaluasi CAPA disampaikan dalam jangka waktu paling lama 30 HK sejak permohonan evaluasi CAPA diterima.

Batas waktu penyampaian dokumen pada setiap tahapan Penilaian Pemenuhan Persyaratan CPOB Fasilitas Pembuatan Obat Impor secara rinci tercantum dalam PerBPOM No. 33 Tahun 2025, dengan ringkasan sebagai berikut:

1. Verifikasi permohonan penilaian dokumen pemenuhan persyaratan CPOB: paling lama disampaikan 20 HK
2. Dektop Inspection :
   • Dokumen lengkap disampaikan paling lama 80 HK.
   • Apabila terdapat perbaikan kelengkapan dokumen, pemohon harus menyampaikan paling lama 20 HK.
   • Apabila hasil Desktop Inspection memerlukan tambahan data, dokumen disampaikan paling lama 30 HK.
3. Local Inspection:
   • 80 HK sejak diterbitkannya hasil evaluasi berdasarkan Penilaian Dokumen Registrasi Obat Impor Terkait Pemenuhan Persyaratan CPOB.
   • 10 HK sejak diterbitkannya hasil Desktop Inspection berupa pernyataan bahwa diperlukan inspeksi setempat

Sesuai Peraturan Badan POM No. 33 Tahun 2025, bukti registrasi yang disampaikan harus telah memasuki tahap Registrasi, sehingga permohonan tidak dapat dilakukan pada tahap pra-registrasi.

Mutual Recognition Arrangement (MRA) yang tercantum pada Peraturan BPOM No. 33 Tahun 2025 pasal 9 merupakan MRA dalam hal pengakuan inspeksi CPOB sehingga MRA tersebut memiliki arti Perjanjian antara dua atau lebih negara/otoritas untuk saling mengakui hasil inspeksi CPOB yang dilakukan oleh masing-masing pihak.

Saat ini, di bawah ASEAN Sectoral MRA on GMP, seluruh negara anggota ASEAN wajib mengakui dan menerima laporan inspeksi dan sertifikat CPOB yang diterbitkan oleh ASEAN Listed Inspection Services (ASEAN LIS) yaitu BPOM – Indonesia, NPRA – Malaysia, Philipine FDA – Philippine, HSA – Singapore, dan Thai FDA – Thailand.

Ruang lingkup MRA yang berlaku saat ini adalah produk obat jadi yang mencakup obat resep dan non resep untuk penggunaan manusia, namun tidak termasuk biopharmaceutical, radiopharmaceuticals, obat tradisional, dan obat uji klinik.

Dengan ada adanya MRA ini, produk obat jadi yang berasal dari Indonesia dapat didaftarkan ke negara ASEAN tanpa perlu dilakukan duplikasi inspeksi oleh regulator obat negara tujuan ekspor.

File MRA tersebut dapat diakses di https://agreement.asean.org/media/download/20150119182953.pdf

Certificate of Application of CPOB for Export Purposes can be submitted via https://e-bpom.pom.go.id/

Documents in softcopy form consist of: CPOB certificate for the dosage form to be exported, pharmaceutical industry permit, contract agreement if the product is tolled

1 (one) CPOB Application Certificate only covers 1 (one) CPOB dosage form

The fee charged is Rp. 100,000,- in accordance with PP 32 of 2017 concerning Types and Tariffs for Types of Non-Tax State Revenue (PNBP) that apply to the Food and Drug Supervisory Agency which is still in effect at this time

2 (two) years from the date of payment of PNBP for CPOB Certificates which have a Validity Period greater than 2 (two) years from the date of payment of the PNBP, if less than 2 (two) years then the Validity Period of the CPOB Application Certificate is the same as the Certificate Validity Period CPOB.

2 (two) Working Days (HK)

Regarding problems with the application such as not being able to download the Certificate/Letter of Approval or the PNBP has been paid but the status is not yet appropriate, you can contact the CPOB e-Certification Application Hotline via WA No. 0898-5321-216

1. Government Regulation no. 5 of 2021 concerning Implementation of Risk-Based Business Licensing.
2. POM Agency Regulation Number 2 2022 concerning Reporting on the Activities of the Pharmaceutical Industry and Pharmaceutical Wholesalers.

The pharmaceutical industry reports activities carried out through the e-Drug Monitoring system (or commonly called e-Was).

1. Reports on the intake and use of active drug ingredients. 
2. Drug production and distribution reports.
3. Reports on the production and distribution of active drug ingredients.
4. Report on the realization of exports and imports of medicines and medicinal substances; And
5. The pharmaceutical industry data report contains information/profile of the pharmaceutical industry including production activities and production equipment used.

All drugs that have a Marketing Permit Number (NIE), including narcotics, psychotropics and pharmaceutical precursors, as well as drugs with Emergency Use Authorization (EUA).

Commodities other than medicines such as health supplements, quasi-medicines, traditional medicines, cosmetics, etc. not included in commodities reported via e-Was.

The delivery frequency for each report is set in POM Agency Regulation Number 2 of 2022 concerning Reporting on Activities of the Pharmaceutical Industry and Pharmaceutical Wholesalers.

Pharmaceutical industries that already have a CPOB certificate can contact the administrator via the following e-mail address and/or WhatsApp number to obtain it username And passwords e-Was:

e-mail: laporanproduksi@pom.go.id

WhatsApp Ewas Ready Medication: +62896 7757 8891

WhatsApp Awareness of Medicinal Raw Materials: +62851-7412-0170

A tutorial for reporting via e-Was can be seen here.

The pharmaceutical industry can convey constraints through:

e-mail: laporanproduksi@pom.go.id

WhatsApp: +62896 7757 8891

CPOB regulatory information can be accessed via Product of law on the KLIK CPOB page or on the page Indonesian Food and Drug Supervisory Agency Legal Documentation and Information Network.

Referring to POM Agency Regulation No. HK.04.1.33.02.12.0883 of 2012 concerning Master Documents for the Pharmaceutical Industry and Traditional Medicine Industry Articles 4 and 5 that in the event of significant changes to the information in the DI-IF/IOT, the Pharmaceutical Industry and Traditional Medicine Industry are required to submit changes to the DI-IF/IOT. IoT no later than 1 (one) month after the change occurs.

Since 2018, the POM has not issued approval of production facility plans.

CPOB guidelines can be accessed on the KLIK CPOB page in the menu Publications – CPOB Guidelines.

POPP CPOB 2012 can no longer be used as a reference. To make it easier for the pharmaceutical industry to implement CPOB requirements, in 2020 the POM has published Q & A Implementation of the 2018 CPOB Guidelines.

Consultations can be done face to face or on line. More information can be seen in the information Location and Service Times. Requests for assistance/consultation can also be submitted via E-Attention.