DRUG Document No.

FM-QA-108
INTERNATIONAL Form: Tentative Inspection Plan Revision No. 00 Page 1 of 1
LIMITED Effective Date 01 JAN 2020

Opening Meeting:

Start Time: 10.00 AM End Time: 10.15 AM

Introductions to the Lead Auditor, Inspectors, Auditee and Company representatives.

Confirmation of Inspection Plan.

Start Time: 10.30 AM End Time: 03.00 PM

Scope and Purpose: Scope of the internal audit related to manufacturing process is to meet the
GMP and regulatory requirements of Raw Material and Packaging Material Warehouse in the
General Building.

Department: Warehouse (Raw Material and Packaging Material Warehouse in the General
Building).

Checking the required documents regarding warehouse like (Not to limited)

 Standard Operating Procedure (SOP) related to warehouse

 Calibration records and daily performance check records
 Environment control records as per requirement.
 Log books relevant to warehouse.
 Stock Control Logbook.
 Goods Receiving Note.
 Inspection Checklist.
and premises.

Discussion meeting: Start Time: 2.00 PM - End Time: 2.25 PM

Discussion meeting with inspectors after internal audit.
Closing and Summery Meeting: Start Time: 2.30 PM - End Time: 3.00 PM
Summary of the observations of the day and closing meeting with auditors and auditees.

13A & 14A, Tongi I/A, Squibb Road, Tongi, Gazipur, Bangladesh.