Alternate audit and accompanying 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.

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

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.)