So, like, the drug control agency, BPOM, or whatever, has officially updated the regulations on Good Drug Manufacturing Practices (CPOB) through BPOM Regulation Number 7 of 2025, the Standard for Good Drug Manufacturing Practices. This move marks a significant adjustment to technological advancements and international standards, especially in the production of sterile drugs and radiopharmaceuticals.
The new regulation changes some provisions from BPOM Regulation Number 7 of 2024 and has been in effect since it was established on March 4, 2025 by the Head of BPOM, Prof. Taruna Ikrar, and was announced by the Ministry of Law on March 20, 2025.
“This regulatory change is a strategic step for BPOM to ensure that the standards of Good Drug Manufacturing Practices (CPOB) in Indonesia continue to be in line with scientific developments, technology, and international standards,” said Taruna Ikrar in a statement on Sunday, May 4, 2025.
This revision also considers harmonization with global standards, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S GMP Guide) and WHO guidelines related to drugs, especially sterile products.
The regulatory revision is designed to adapt to the dynamics and advancements in science and technology in the pharmaceutical field. In addition, this regulation has considered harmonization with international standards/guidelines in drug manufacturing, especially sterile products, such as the Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products (PIC/S GMP Guide) and WHO Guidelines.
So, like, CPOB is a standard aimed at ensuring that the quality of drugs produced meets the requirements and intended use. This standard applies to the manufacture of drug substances and drug products used by humans.
In drug manufacturing, comprehensive control is essential to ensure that the public receives high-quality drugs. “Without CPOB standards, the drugs produced cannot be used to save lives, restore, or maintain health,” he added.
Therefore, drugs must not only meet a series of testing requirements but also be controlled and of high quality. “Starting from raw materials, packaging materials, production processes and quality control, buildings, equipment used, and personnel involved,” continued Taruna Ikrar.
Taruna explained that in improving regulations for sterile products, which also include radiopharmaceuticals and biologically-based drugs, enhancements in sterilization procedures, contamination control, and aseptic processing are considered.
Institutions engaged in drug manufacturing, or in the production of radiopharmaceutical preparations, which carry out activities in the manufacturing of sterile products, must comply with the provisions in BPOM Regulation at the latest within 12 months.
If the facility implements lyophilization processes (freeze-drying) with a loading or unloading system carried out without passing through barrier technology, automatically or protected by a closed barrier system, they must comply within a maximum or at the latest within 24 months.
“By applying quality risk management principles throughout the drug production process and enhancing control over sterile products, we hope that the national pharmaceutical industry can become more competitive and able to produce safe, effective, and high-quality drugs for the public,” he concluded.
