In the process of registering for Pemeriksaan Sarana Balai (PSB) in Indonesia, distributors are required to have specific areas that comply with regulatory provisions. These areas ensure that product distribution is carried out safely, systematically, and in accordance with applicable standards. Here are the required areas for distributors:
1. Shipping Area (Area Pengiriman)
This area is used for packaging and shipping products to customers or business partners. Key considerations in the shipping area include:
- Final inspection procedures before shipping products
- Recording system for incoming and outgoing goods
- Cleanliness and orderliness to prevent product damage
- Products must be stored on pallets to prevent contamination from the floor
2. Receiving Area (Area Penerimaan)
This area is used to receive products from suppliers or manufacturers. Its primary function is to ensure that incoming goods match the ordered specifications and quantities. Important aspects of the receiving area include:
- Physical inspection of incoming goods
- Recording of received products
- Adequate space for loading and unloading
- Products must be stored on pallets
3. Quarantine Area (Area Karantina)
A quarantine area is required to store problematic or non-compliant products until further decisions are made. Main functions of the quarantine area include:
- Isolating damaged products or those requiring further inspection
- Recording and reporting quarantined products
- Restricted access to prevent cross-contamination
- Damaged or non-compliant products must be labeled as “QUARANTINED” or “REJECTED” and separated from standard products
4. Product Storage Room (Warehouse/Gudang)
The warehouse is the main area for storing products before distribution. During storage, regular monitoring of product quality must be performed. To comply with PSB standards, the warehouse must be equipped with:
- Air Conditioning: Air conditioning is mandatory to maintain appropriate temperatures for product storage. Temperatures must be maintained between 15-30°C, depending on the product’s requirements. Some cosmetic products may even require refrigeration to preserve quality.
- Pest Control: A pest control system is necessary to maintain cleanliness and prevent infestations.
- Rat Box: Rat traps as part of the pest control system.
- Thermohygrometer: Equipment to monitor temperature and humidity to meet storage requirements.
- Storage Racks: Racks must meet hygiene standards and be easy to clean, free from dirt, dust, and pests.
- APAR (Fire Extinguisher): Fire extinguishers must be available in the warehouse as a preventive measure.
5. Labeling Area (Area Pelabelan)
This area is designated for affixing labels on products before distribution. Labels are essential to provide clear information to consumers and comply with legal requirements. Key points in the labeling area include:
- Verification process to ensure label accuracy
- Recordkeeping of labeled products
PSB Audit Process
The PSB audit is mandatory for businesses holding MD or ML distribution permits, whether conducted at the processing plant or the warehouse for imported goods such as medicines, cosmetics, and food.
- The PSB audit is conducted by the Indonesian National Agency of Drug and Food Control (BPOM).
- In addition to inspecting the physical facilities, the audit also includes a review of documents such as SOPs and supporting records.
- The audit process typically takes around 6 hours, depending on the auditor’s inspection speed and arrival time.
How INSIGHTOF Can Assist You
INSIGHTOF is a leading regulatory service provider specializing in assisting medical and cosmetic companies with product registration in Indonesia. With a proven track record of over 430 successful registrations, INSIGHTOF offers expert guidance through complex regulatory processes, including PSB compliance. Whether you are navigating product approvals, importation, or post-market surveillance, our dedicated team ensures a smooth journey toward regulatory compliance. Partner with INSIGHTOF for reliable, comprehensive solutions in the ever-evolving regulatory landscape.
For any inquiries, please feel free to contact us at marketing@insightof.co.id.
