GMP Supplier Audits in Japan, Reported in English
GMP Supplier Audits in Japan, Reported in English
Need a third-party GMP audit of an API, excipient or drug product manufacturer in Japan? We audit your supplier on your behalf in Japanese and deliver the audit report in English. Pharma Planning Co., Ltd. is a GMP consultancy based in Atsugi, Kanagawa, Japan. We also conduct internal audits, mock audits, remote audits and audits of sites outside Japan.
AUDITS IN JAPAN
How we audit your supplier in Japan
We audit your supplier in Japan in Japanese. You receive the audit report in English.
Tell us about the audit
Share the site you want audited, the products or materials it supplies, the requirements to audit against and your preferred timing.
We plan the audit with you
We plan the audit based on your requirements. Our consultants work with requirements such as Japanese GMP, PIC/S GMP, US FDA cGMP, ICH Q7 (GMP for active pharmaceutical ingredients), investigational drug GMP, GMP for excipients and GDP.
We audit the site in Japanese
Our auditors audit the site in Japanese, directly with the site's staff, on site or remotely. Supporting documents such as SOPs and validation records can be translated between Japanese and English. Interpretation and translation support
You receive the report in English
We deliver the audit report to you in English.
We verify CAPA on site
If needed, we verify on site that the site has implemented corrective and preventive actions (CAPA) for the findings. For a new supplier or contract manufacturer, we can also carry out a qualification audit before you sign a supply or manufacturing agreement.
Requirements we work with
We audit against the requirements you specify. For a wider assessment against these requirements, see GMP Gap Analysis.
Audits on our clients' behalf
100+audit projects since 2018*1
Part of the 1,100+ projects in our public track record.*1 View our audit projects
*1 Public track record (2018–2026): 1,183 projects in total, of which 111 are listed under "Proxy Audit". Data checked: November 5, 2026.
More audit services
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01Periodic Supplier Audits and Supplier Qualification
We conduct periodic audits of API, excipient and drug product (solid and sterile) suppliers on your behalf.
Based on past audit results, we verify on site that the improvements submitted by the auditee have been properly implemented.
Before purchase or contract, we assess a new supplier's capabilities on your behalf as part of your supplier qualification.
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02Self-Inspections (Internal Audits) on Your Behalf
To address challenges such as the following, we propose a self-inspection (internal audit) program, and our experts conduct the audits on your behalf.
We conduct self-inspections, but they no longer detect moderate deficiencies, and we are worried that issues are being missed
We do not know specifically what to check
We do not have enough auditors
We want a third party to confirm that CAPA is being properly implemented for deficiencies found in self-inspections
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03Mock Audits
Before an inspection by a regulatory authority such as PMDA or FDA, or an audit by a contracting company, we audit your site and identify items that could lead to findings.
Mock audits by former FDA investigators who partner with us are also available.
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04Audits of Sites Outside Japan on Your Behalf
We work with local consulting firms or partner consultants in the US, Europe, China, Southeast Asia and other regions.
If you want to audit an overseas manufacturing site, for example as part of a supplier audit, but lack the resources, please feel free to consult us.
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05Remote Audits
We also conduct remote audits. We plan the audit with you based on the tools you use.
Supported tools: Microsoft Teams, Zoom and Google Meet.
FAQ
Frequently asked questions about audits in Japan
Yes. As a third-party auditor, we audit API, excipient and drug product (solid and sterile) suppliers and contract manufacturers in Japan on behalf of our clients.
Our auditors conduct the audit in Japanese with the site's staff, and we deliver the audit report in English.
Yes. For a new supplier or contract manufacturer, we can carry out a qualification audit and assess the manufacturer's capabilities on your behalf before you sign a supply or manufacturing agreement.
We audit against the requirements you specify. Our consultants work with requirements such as Japanese GMP, PIC/S GMP, US FDA cGMP, ICH Q7 (GMP for active pharmaceutical ingredients), investigational drug GMP, GMP for excipients and GDP.
Yes. Based on past audit results, we verify on site that the improvements submitted by the auditee have been properly implemented.
Yes. We plan remote audits with you based on the tools you use, such as Microsoft Teams, Zoom or Google Meet.
Yes. We conduct mock audits before inspections by regulatory authorities such as the FDA, including mock audits by former FDA investigators who partner with us.
Please contact us through the inquiry form with the site, the products it supplies and your preferred timing.
FDA Inspection SupportInterpretation and TranslationRequest an audit
Track Record
PERFORMANCE
Explore the projects we have supported so far.
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For questions or consultations about our services, please call us or use the contact form.
Hours: weekdays 9:00–18:00 (JST)
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