Sanofi Bangladesh Limited

Tongi lA Site

Audit Agenda
GMP Audit API
ACTIVE FINE CHEMICALS LTD
Navana Osman @ Link, 2141D, Tejgaon- Gulshan Road,
Tejgaon, Dhaka- 1208, Bangladesh
8th May, 2018
Subjects and timings may change depending on the progress of the audit.
Audit team might split to cover separate topics in parallel.
Scope: AFI: $itagliptin phosphate monohydrate INN for Sanofi Bangladesh Limited.
Referential: ICH Q7: GMP, EU GMP (Eudralex Vol 4.) for APls & Sanofi Directives

Auditors: Lead Auditor : F.M. Kabirul Hasan - (Sr. Manager Quality Assurance, Sanofi Bangladesh Ltd, Tongi)
Co-Auditor : Badrul Haider Chowdhury - (Head of Quality operations)
Co-Auditor : lshtiq Ahmed - (Head of Manufacturing)

09:00 10:00 lntroduction of the involved people

Opening Presentations from Site Management (nof more than 15 minutes
p/ease) Layout of facilities, List of products, Production description, Organization
charts, Headcount, Flow of material, lnspections from Regulatory authorities.
Presentation of the production processes (flow chart of the synthetic scheme,
steps, critical parameters)
Short presentation by Lead Auditor
Review of Audit Agenda
Progress on the corrective actions implemented since last sanofi audit (if
any)
PIease provide the following documentation at the beginning of the audit:

rocess flow diagrams for product and regulatory file

he two last Product Quality Reviews

,.,' $chematic drawings of production areas, with zoning, personnel & material
flows

Confidential for Internal Use Only

lnlbnlation in this document is confidential property of Sanofi, which is privileged and exempt from disclosure under applicable
law and/or subjectto copyright. This document is intended tbr Intemal Use Only and should not be copied, reproduced,
distributed or forwarded any further or archived in any project file.
GMQO/End to End Supply Chain/Audit Manufacturing Third Parties

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 10:00 12.00 Site tour and audit following the material flow applicable to the products.
. Warehouses (Raw materials, Bulk, Finished goods and solvents farm)
- lncoming goods inspection, labeling, sampling
- Rejected and returned goods
- Finallabeling & shipment
- Pest control
- Light, Temp and humidity monitoring (mapping)
- Labeling system
- Distribution
. Prod Manufacturing and Packaging/Labeling areas (Prevention of Cross-
contamination and Mix-up (Gowning Procedures; Gleaning and line
clearance logs)
- Dispensing Area
- Manufacturing and processes (in-process control)
- Packaging areas
- Facility and equipment
- Environment Monitoring and zoning
- Batch Record
. Maintenance / Engineering / Utilities ((water, air handling, gasses, etc)
- Water System (sampling points, calibration, loops, etc.)
- AHU- HVAC Area ((layout, maintenance, monitoring)
. Quality control Lab:
- Chemistry Laboratory, systems, and practices
- Post marketing Stability / Testing
- Retention Samples
- Reference standard and solution preparation
- Qualification and calibration
- Analytical Validation
- Specification
- Quality control test result calculation
. QC Micro Labs:
Equipmen
Environmental monitoring during selected period
Personnel monitoring
- Water Systems Testing
o HSE View:
Disposal of waste
- Security
Personnel protect
13:00

13:00 1 6:30 Documentation Review:

Quality Control System:
r Sampling and samples receiving area
r Finished product specs and report
r Data handling and audit trials,
I OOS results handling
r Reagents, solutions, reference standards, media preparation etc. Raw Data and lab
Confidential for lnternal Use Only
lnformation in this document is confidential property of Sanofi, which is privileged and exempt from disclosure under
applicable law and/or subject to copyright. This document is intended for lnternal Use Only and should not be
copied, reproduced, distributed or forwarded any further or archived in any project file.

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/

notebook management
r Equipment qualification/calibration lmaintenance/log books
r Retention samples (storage area)
r Stability testing program and results

Manufacturing and Gontrols:

r Batch Manufacturing Record
r ln Process Controls
r Calibrations
r Preventive Maintenance
r Environmental monitoring SOP and results

Quality Management Systems:

r Site Master File
r Documentation Control
r Batch Record (BR) review
r Annual Products Review
r Change Control
r Handling of Deviations//Complaints
r Training Procedure and program
r Market Complaints and recall
r Medical Examination
r lnternal audits (Self-inspection program)
r Batch release procedure
r Return product handling
r Suppliers management (approved suppliers list)
r Data integrity overview

Validation and Qualification:

r Validation Master Plan
r Process Validation.
r EquipmentQualifications
r Cleaning validation
r Analytical method validation
r Computerized system validation

Water System / Utilities

r System drawings
r Operational SOP's
r Qualification and validation documents
r Sanitization overview
r Sampling program
r Micro and chemical results and trending overview

Preventive Maintenance (program, procedures, records)

Galibration program (program, procedures, records)
1 6:30 16.45 Auditors' meeting- Preparation of the final wrap

Confidential for lnternal Use Only

lnformation in this document is confidential property of Sanofi, which is privileged and exempt from disclosure under
applicable law and/or subject to copyright. This document is intended for lnternal Use Only and should not be
copied, reproduced, distributed or forwarded any further or archived in any project file.

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 16'.45 17'.15 Audit Close out meeting with site management.

17'.20 Auditors leave the site.

ATTACHMENT:

Personnel & Requlations

the "qualified persons" where applicable.

Follow-up of previous audit

Product and Process

Premises

The list of documents is suggestive and all documents from the list may not be reviewed or additional
documents may be requested.
Auditor could request for and review documents during the facility tour.
Please ensure all your key personnel are available and all your documents/records are easily
retrievable.
. Site layout will be reviewed before proceeding for plant tour.
o Please make a copy of the reaction scheme and process flow available before the plant tour.

. Presentation
. Site Master File
. Regulatory certificates (local & lnternational)
o Process flow / Reaction scheme / Route of synthesis
. Residual Solvent details
. Typical Certificate of Analysis (Last 3 Batches)
. TSE/BSE Certificate
We thank you for your collaboration!

rnrormation in this document is conrident:lJ,:3:lffiit8i,l$:'JfiLHi"f,ll''"n* and exempt rrom discrosure under

applicable law and/or subject to copyright. This document is intended for lnternal Use Only and should not be
copied, reproduced, distributed or fonivarded any further or archived in any project file.

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