CPPKRTB Certification (Good Manufacturing Practice for Household Health Supplies)
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What is CPPKRTB Certification?
CPPKRTB stands for Cara Produksi Perbekalan Kesehatan Rumah Tangga yang Baik, or Good Manufacturing Practice for Household Health Supplies. This certification is issued by the Indonesian Ministry of Health to companies producing PKRT (Household Health Supplies) that meet quality and safety standards in their production process.
Legal Basis of CPPKRTB
Legal Basis of CPAKBTo enforce regulatory compliance among medical device and household health supplies (PKRT) manufacturers, the Ministry of Health requires companies to implement CPAKB and CPPKRTB standards, proven by holding the respective certificates.Regulations include:
- Government Regulation No. 5 of 2021 on Risk-Based Business Licensing, Annex II: Medical Device and PKRT manufacturers must have a CPAKB/CPPKRTB certificate before starting operations.
- Minister of Health Regulation No. 20 of 2017 on Good Manufacturing Practices for Medical Devices and PKRT:
- Article 2(1): Companies must apply CPAKB or CPPKRTB depending on the type of production.
- Article 2(2): Compliance must be proven through certification issued after a successful audit.
- Minister of Health Regulation No. 14 of 2021: The CPAKB/CPPKRTB certificate is valid for 5 years and mandatory for all producers.
We urge manufacturers to apply for the CPAKB/CPPKRTB Certificate as soon as possible. The process may take 4–5 months after all documents are complete, and delays may result in warnings (SP) from the Ministry of Health.
Benefits of Having a CPPKRTB Certificate
- Required to obtain distribution licenses for PKRT products
- Enhances product credibility in the market
- Ensures compliance with national quality and safety standards
Requirements to Apply for CPPKRTB Certification
- Valid business licenses (NIB, NPWP, appropriate KBLI codes, etc.)
- Factory layout and production flow design
- SOP documentation and production systems
- Quality and sanitation management documents
- Trained technical personnel
CPPKRTB Certification Process
- Initial consultation & facility readiness check
- Document preparation and SOP development
- Submission to the Ministry of Health
- On-site audit by Ministry of Health
- Issuance of CPPKRTB certificate
Why Choose Us?
- Extensive experience assisting Alkes and PKRT manufacturers
- End-to-end support from consultation to certification
- Assistance with SOP, documentation, and facility layout revision
FAQ – Frequently Asked Questions
- Can a new company apply for CPPKRTB?
Yes. As long as your business is legally registered and has a production facility that meets the Ministry’s standards. - What if we don’t have SOPs or technical staff yet?
We provide comprehensive support, including preparing SOPs according to Ministry guidelines and helping you recruit qualified technical personnel. - Is it mandatory to own a production facility?
Not always. You can use a certified third-party manufacturer (maklon) if you have a legal partnership agreement and they meet CPPKRTB standards. - Can the certification process be done online?
Most administrative steps can be handled remotely. However, the facility audit is conducted in person by the Ministry of Health team. - How do I start the process with PT Multi Jasa Berjaya?
You can contact us via WhatsApp or the contact form on our website. We'll schedule a consultation session to assess your company’s readiness and explain the entire process in detail. - What are the fees for CPPKRTB certification assistance?
Fees depend on your company’s condition and readiness. Please contact our team for the best offer and free consultation.
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