Alternate audit and accompanying audit

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We, Pharma Planning Co., Ltd. are acting as a proxy in a variety of audits. We will deal with the matter according to requests from customers. Please feel free to make inquiries.

1.Alternation of supplier audit


We will act as a proxy for periodic audits of APIs, diluents, and drug products (solid and sterile).

We will on-site check appropriate implementation of improvements submitted by the auditee based on previous audit results.

We will also evaluate the ability of a manufacturer before procurement or contract as a proxy.

2.Alternation of self-inspection (internal audit)


Alternation of self-inspection (internal audit)

We, Pharma Planning Co., Ltd., will propose a self-inspection (internal audit) program to deal with the following problems.
We will conduct an alternate audit by an expert in the following cases:

  • When moderate inadequacies cannot be detected through self-inspection. When any overlooking of inadequacy is worried
  • When concrete actions to take are not known
  • When auditors are insufficient
  • When proper operation of CAPAs taken against inadequacies detected in the self-inspection need to be checked by the perspective of a third party

3.Mock audit


We, Pharma Planning Co., Ltd., will conduct an audit and extract potential problems leading to findings before the audit
by regulatory authorities, such as PMDA and FDA, or that by the consignor.

(Enter here for details concerning support to deal with FDA inspections.)

4.Alternation of an audit on an overseas manufacturing site


We, Pharma Planning Co., Ltd., have local consulting companies or partner consultants in countries including USA, Europe, China,
and south-eastern Asia.

Please feel free to consult us when you wish to conduct a supplier audit of an overseas manufacturing site but lack in resources.

5.Remote audit


Due to COVID-19 influence, our customers are facing difficulty to conduct GMP/QMS on-site audit.
To overcome above situation, we’ve just started Remote Audit.
We would select suitable remote tool i.e. AVATOUR,Microsoft Teams,Zoom,Google Meet etc, based on customer’s request.

Please contact us through the following email form.

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