Products & Services Audit Reports

Audit Reports Availability

Audit reports for Planova™ Plant and Planova™ Oita Plant are now available for purchase from Rx-360, an international pharmaceutical supply chain consortium.
Purchasing these audit reports allows biopharmaceutical companies to obtain audit reports for Planova™ manufacturing facilities without having to conduct the audits directly, which could potentially help to save time and costs. Other features and benefits of purchasing the audit reports are as follows:
  • Companies could save time and cost of traveling to Miyazaki and Oita, Japan.
  • Companies could save cost and labor of contracting third-party auditors to conduct in Japan.
  • Both FDA and EMA accept audits conducted by third-party auditors, including these reports.
  • Reports can be purchased by Rx-360 members or non-members.
If you are interested in licensing the reports, please contact “Brian Shipley” at
Please indicate the following audit number in your inquiry: ​Planova Plant (JA-2723) , Planova Oita Plant (JA-2724)
Audit Number Site Start Date End Date Audit Method Audit Guideline Used
JA-2723 Asahi Kasei Medical Co., Ltd. - Nobeoka, Japan 12/13/22 12/14/22 Onsite Basic Chemicals / Raw Materials; Supply Chain Security
JA-2724 Asahi Kasei Medical Co., Ltd. - Oita-city, Japan 12/15/22 12/15/22 Onsite Basic Chemicals / Raw Materials; Supply Chain Security
  Planova™ Plant Planova™ Oita Plant
Planova™ 15N, 20N & 35N and 75N
Planova™ BioEX
Asahi Integrity Test Solution Kit  
Please note that customers purchasing Planova™ or Planova™ BioEX may receive filters manufactured either in Planova™ Plant or Planova™ Oita Plant, and thus may need to purchase audit reports from both plants.
Should you have any questions regarding these audit reports, please contact us.