Editor's note: This article was originally published on December 2, 2024, and was updated on December 31, 2024, as per the latest developments.
On December 27, 2024, CAA approved the proposal, and it was implemented with immediate effect.
On November 21, 2024, Japan's Consumer Affairs Agency (CAA) released proposal No. 235110008 to revise Guidelines for the Good Manufacturing Practice (GMP) of Tablets, Capsules, Etc. (hereinafter the "GMP Guidelines"), with the aim of improving regulatory measures for similar products after the damaging incident involving Kobayashi Pharmaceutical's red yeast rice products. Any comments can be submitted before December 23, 2024 via e-Gov opinion form.
As revealed by the proposal, food products containing microbial-related materials may pose unexpected issues due to the microbial growth process and manufacturing procedures, which raises concerns compared to regular foods. Additionally, many tablet and capsule products may not show abnormalities in color or flavor, necessitating heightened attention in manufacturing and quality control.
Therefore, the GMP Guidelines is revised as follows:
1. Updating Materials Required for Creating Product Specification Documents
Manufacturers must create "Product Specification Documents" for each product, detailing the following items, and maintain these documents at each manufacturing facility involved in the production of the respective products.
Product name and trade name
Product ingredients and quantities
Specifications and testing methods of raw materials, products, and intermediates
Specifications and testing methods of packaging
Methods and procedures for product manufacturing
Standard batch size and the basis for it
Storage conditions for intermediates
Storage conditions for products and expiration or best-before dates
Recommended daily intake and precautions for use or handling
Documentation detailing agreements with contractors for any part of the manufacturing process
(New) Standards and testing methods for the equivalence and homogeneity of microbial-related materials
2. Adding Product Specification Documents Creation Guidelines
To enhance safety regulation, CAA establishes the Draft Appendix: Guidelines for Preparing Product Specification Documents for Tablet and Capsule Foods Using Microbial-related Materials, which includes the purpose, application scope, target operators, and implementation details, ensuring comprehensive oversight and compliance of the manufacturing of these products.
Notably, microbial-related materials cover those made from microorganisms, such as algae, through cultivation or fermentation. However, products that contain microbial-related materials traditionally used as food ingredients will be exempted if they meet any of the following conditions:
Products are made in a controlled manufacturing process that prevents unintended contamination and growth, such as in a closed system. Additionally, the addition of microbial-related materials is equal to or lower than that of typical food products.
The final products have sufficient distribution records.