As projected in a Nov. 2020 StabilityHub release, Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a new ordinance and an accompanying notification (explanatory document) about Japanese GMP’s on April 28, 2021. These will be become effective on August 1 of this year. The GMP notification is a 124 page guidance issued by the GMP group of MHLW and includes the following features:

  • Many ICH and PIC/S documents are referenced in the main text as useful guidances to follow.
  • A responsible officer, (referred to as senior management in ICH Q10), must be assigned to be responsible for ultimate pharmaceutical issues.
  • Approved items must be followed. Alternative methods are not allowed, except for those which refer to official compendium. Alternative methods may be interpreted as a GMP violation after August 1.
  • Occurrences of OOS, and OOT possibly leading to an OOS, must be reported to marketing holders with all information necessary to make a judgement regarding issuing a recall.
  • Contracted functions related to pharmaceutical quality need to have documentation of responsibilities and periodic confirmation of performance and compliance. Relevant functions include: cleaning or maintenance of facilities, testing of materials and reference samples, inspection of equipment and calibration of gauges, storage and testing-related stability monitoring, document storage related to the biological raw materials, etc.
  • Changes which may effect previously approved quality commitments must be communicated by the manufacturer and confirmed by the marketing authorization holder.
  • Significant deviations must be reported to the marketing authorization holder.

Some of the requirements are perceived to be quite tough and pharmaceutical companies are discussing potential counter proposals.

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