SOP for Pharmacy in Indonesia (Free PDF Download)

Pharmacy SOP for Indonesia (Free PDF Download)

A complete standard operating procedure template for opening and running an apotek (retail pharmacy) in Indonesia — covering OSS licensing, the Apoteker Penanggung Jawab (pharmacist in charge), BPOM product requirements, recall handling, recordkeeping and side-effect monitoring. Adapt the bracketed fields to your premises and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage, recall and recordkeeping procedures required to operate an apotek in Indonesia in line with Ministry of Health pharmaceutical service standards and BPOM product regulations.

2. Scope

Applies to the Apoteker Penanggung Jawab (APA), all pharmacists, pharmacy technical staff and support staff at [Pharmacy Name], [Address].

3. Regulatory Background

• An apotek licence is obtained through the OSS system: NIB (business identification number), the apotek standard certificate (sertifikat standar apotek) and the apotek permit (izin apotek).
• Every apotek must appoint an Apoteker Penanggung Jawab (APA) — the pharmacist in charge — holding a valid STR (registration letter) and SIP (practice licence).
• Permenkes 73/2016 sets the pharmaceutical service standards: prescription screening and review, dispensing, drug information services (PIO), counselling, home pharmacy care, drug therapy monitoring (PTO) and side-effect monitoring (MESO).
• BPOM (Badan Pengawas Obat dan Makanan) regulates the safety and quality of medicines and food products sold in Indonesia.
• Narcotics and psychotropics must be kept in locked, separate storage.
• A written product tracking and recall SOP is required, and prescription and service records must be kept for the period the regulations require — confirm current retention rules with the local health office (Dinas Kesehatan).

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the business through OSS and obtain the NIB.
2. Appoint the APA (registered pharmacist with valid STR and SIP) and prepare the building layout, location map, staff list and facilities list.
3. Obtain the apotek standard certificate and the izin apotek through OSS before opening.
4. Display the current izin apotek and the APA's practice licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from licensed distributors (PBF) and registered products.
2. Verify distribution permit numbers on every incoming consignment.
3. Check expiry dates, batch numbers and physical condition on receipt; quarantine anything suspect.

5.3 Storage

1. Store per label conditions; maintain the cold chain for thermolabile products with temperature logs.
2. Keep narcotics and psychotropics in locked, separate storage with restricted access.
3. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Screen and review every prescription (administrative, pharmaceutical and clinical review) before dispensing.
2. Dispense only against valid prescriptions for prescription-only medicines, verified by a pharmacist.
3. Provide drug information (PIO) and counsel every patient on dosage, duration and storage.
4. Record each dispensing in the prescription register.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (BPOM, manufacturer or internal finding), the APA initiates the recall immediately.
3. Identify and quarantine all affected batches, notify patients where required, and return stock per the recall notice.
4. Document the entire recall: batches, quantities, notifications, returns.

5.6 Pharmacovigilance

1. Monitor for side effects (MESO) and report suspected adverse drug reactions per BPOM requirements.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, purchase invoices, temperature logs, recall files and MESO reports for the period the regulations require.
2. Make all records available to Dinas Kesehatan and BPOM inspectors on demand.

6. Pro Tips

• Do the triple prescription review. Permenkes 73/2016 expects administrative, pharmaceutical and clinical screening on every prescription — make it a checklist, not a memory exercise.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Lock the narcotics cabinet properly. Separate locked storage for narcotics and psychotropics is a licence condition, not a suggestion — inspectors check it first.
• Log temperatures daily. Cold-chain logs are the first document requested after a potency complaint.
• Keep the APA's SIP current. An expired practice licence for the pharmacist in charge invalidates the apotek's operating basis.

7. Frequently Asked Questions

Q1: Who licenses an apotek in Indonesia? A: Licensing runs through the OSS system — NIB, the apotek standard certificate and the izin apotek — while BPOM regulates the safety and quality of the medicines sold.

Q2: Who must be the pharmacist in charge? A: An Apoteker Penanggung Jawab (APA): a registered pharmacist holding a valid STR and SIP, appointed as the person responsible for the apotek.

Q3: What service standards must an apotek follow? A: Permenkes 73/2016: prescription screening and review, dispensing, drug information (PIO), counselling, home pharmacy care, drug therapy monitoring (PTO) and side-effect monitoring (MESO).

Q4: How are narcotics stored? A: In locked, separate storage with restricted access — a licence condition under the pharmacy licensing regime.

Q5: How are adverse drug reactions reported? A: Through side-effect monitoring (MESO) reports per BPOM requirements, with a copy kept in the pharmacy's records.

Q6: Is a recall SOP mandatory? A: Yes — a written product tracking and recall procedure is required, with batch-level traceability from supplier to patient.