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Quality Expert/Inspector -Curriculum Vitae-
Name : G.Sundar
Designation : Director
Total Experience: 22 years
Profile Summary: G.Sundar developed profile as quality practitioner with 22 years experience in the
field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. Quality
management experience covers the implementation of Quality tools in bulk drugs, formulation companies
and CRO. Mr areas of expertise covers Total Quality Systems as per cGMP, GLP, GCP and as per EMEA
,USFDA, MHRA and MCC,TGA,ANVISA, Japan guidelines Having competent QA/QC knowledge in API and
formulation field of USFDA; cGMP, ICH Q8,Q9,Q10, Q7, EMEA cGMP, MHRA Orange Guide and OECD GLP
guidelines. Having a strong background on regulatory guidelines for DMF, CTD Documents (ICH M 4 Q),
ANDA and BA/BE Computer Systems and Software Validation, 21 CFR scope, Equipment Validation
(DQ/IQ/OQ/PQ), analytical and bio-analytical method validation, process validation (Prospective,
Retrospective and Concurrent), preparation BMR, MFR, Validation Master Plan, Site Master File, Training
Schedule, Quality Manual, analytical work sheet preparations, impurity profiling, stability studies (for
Both Drug Substance and Drug Product), OOS, OOC, other deviations and change controls. Got a very good
working knowledge on ISO 9001:2000 (QMS), EHS system and ISO 14001:2005. Undergone through
regulatory Audits like USFDA, MHRA, WHO, DCGI-INDIA, TGA and EMEA, MHRA and prepared documents
and SOPs for above-mentioned regulatory bodies and for ANVISA Brazil. Additionally experience in
Auditing Bio-Equivalence studies and Clinical Trials Phase I-IV.
Maintains Total Quality Management Systems as per cGMP, GLP, GCP and EMEA, USFDA, MHRA and MCC,
Japan GUIDELINES and Conducting of Computer Systems and Software Validations. Having the competent
QA/QC knowledge in API and Formulation Field.
PRIMARY EXPERTISE:
22+ years of FDA/EU-related expertise with Good Manufacturing Practice (GMP) regulations,
Quality System Regulation (QSR) and Part 11;EU GMP Annex 11 regulations
A combination of work experience as a former FDA Investigator; management positions within
pharmaceutical companies in a regulatory compliance role; and as a director/consultant in a
business unit of a very large organisation, specializing in GMP regulatory compliance matters.
Extensive experience with preparing companies for FDA Pre-Approval inspections.
Hands-on experience with designing & building Quality Systems.
Experience working a software quality assurance (SQA) role
Excellent technical writing ability
Authored and co-authored several technical articles.
Frequent industry speaker on a wide variety of topics.
Expert GMP and Quality Systems Consultant skilled to provide timely
solutions to clients in the pharmaceutical, biotechnology and medical device
industries. Worked as a Investigator who has also worked in the pharmaceutical and biotech
industries as a regulatory compliance professional.
Can assist by performing the following services:
Auditing: GMP, Quality Systems, Management Controls, FDA-type Mock PAIs and Inspections,
Verification Audits and Effectiveness Checks, Gap Analyses
Regulatory Compliance: 483/Warning Letter responses and other
Correspondence, Consent Decree remediation activities, preparation for or
Attendance at FDA meetings
Training: General GMP topics, FDA interaction and preparing for FDA
Inspections, 1:1 mock interviews, auditing techniques -Inspection Management Process and
Planning: Review hosting process and site presentations, tour routes, front/back room
management, document Management, employee coaching

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-Data Integrity: Directed audits and analysis, company program development, subject matter training
-Technical Writing: Validation Protocols and Reports, SOPs, Annual Product
Reviews, FDA correspondence, audit responses, strategic plans, trend analysis reports, other technical
reports.
-Data Trend Analysis: Collection, review, analysis and summary reporting for
Deviations, OOS, Change Controls, CAPA, Complaints, Product Returns
KEY ACIHEVEMENTS
• USFDA GMP AUDIT faced and achieved Zero 483. March 10-13;2014
• USFDA GLP AUDIT for Bio-analytical laboratory-Audit passed with minimum observations March
03/20 - 03/25/2014
• USFDA Bioequivalence Audit –Surprise unannounced Inspection-11/03 - 11/06/2014-Zero 483
• Sterile facility establishment with modern technology.
• GMP failed site brought into compliance and appreciated by regulatory agencies USFDA and MHRA
during Alkem and Medley tenure. –MHRA Risk based Inspection success
• Passed third party customer Audits from overseas like Hospira, Merck, Agila, Mylan; BMS USA;
• Also done nearly 35 trainings covering chapters from GMP;GLP and GCP ;Data Integrity etc,.
• Got best Team award from Dr. Kiran Mazumdarsaw (Biocon CMD) for implementation of Phase I
clinical trial Quality systems in clinigene International Limited.
• Got Best Documentation Award and Best PQ Award from Thermo Fischer Scientific –USA (two
Consecutive Years) for Clinigene International Limited.
Current profile:
.-Management of several medium to large GMP compliance projects
-Numerous extensive reviews and evaluation of equipment and utility system
qualifications, process and cleaning validation efforts and validation master
plans.
-Expertise in evaluating various sterilization approaches including moist heat, filtration, ethylene oxide
and gamma irradiation.
-Preparation of GMP improvement plans, compliance standards and Conduct audit
With current extensive checklists (e.g. Pre-Approval Inspections, Active Pharmaceutical Ingredients,
HVAC qualification, corporate/site stability program)
-Preparation/review of 483 and Warning Letter responses to FDA, aseptic media
fill protocols, 21 CFR Part 11 risk assessments
- Evaluation of new drug and device development activities
- Delivered a number of industry training presentations on a multitude of GMP-related topics.
Recently faced Regulatory Audits:
The following Audits were faced recently and prepared compliance report and monitored the compliance
1.UK-MHRA-Three times (2011,2012,2014)
USFDA- 2002, 2006 2008,2011, 2012, 2014(3) –Total 7 USFDA-one Unannounced USFDA and got zero
483
3.WHO –Geneva-two times (2010,2011,2012,)
4.TGA-Australia-(2012)
5.WHO-DCGI-many times
6.ANVISA- Two times
7.NDA-Uganda-Two times
USFDA audit reports unremarkable status of QMS mentioned by USFDA in EIR and MHRA audit
Report
Audits Done by G.Sundar as Lead Auditor- API Audits: (as per ICH Q7, EUGMP Part II, APIC, PIC(S),
USFDA 210 and 211 done for the following companies:
1. Orchid pharmaceuticals, Chennai-2011
2. Hikal Pharmaceuticals-Bngalore-2011
3. GlenMark pharmaceuticals-Ankeleswar-2013

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4. Praveen laboratories-Surat-2013 Exemed Laboratories limited-Ahmedabad-2013 (after my Audit
, USFDA passed)
5. Aarti Laboratories-2013
6. Bioplus , Hosur, 2010.
7. Embio Limited-2013.
8. Alkem laboratories –Ankeleswar-2012
9. Lyca Drugs-Ankeleswar-2012
10. Posch chemicals and intermediates Limited-Hyderabad
11. HLL life sciences API facility
12. Calyx at Tarapur-USFDA/EU –API GMP Compliance Audit work
13. Spansules Pvt limited
14. EU customer for API cGMP audits
Conducted GMP/GLP audits of more than 30 APIs, Excipients, 50 Formulation Contract Manufacturing
Units (all types of formulations,), 13 Contract Research and Analytical laboratories, 4 Clinical research
CROs during my career

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Specific skills:
Complete Implementation and monitoring
of Pharmaceutical QMS systems
Laboratory Quality Assurance
Expert in implementation and monitoring
of ICH Q8(QbD),ICH Q9 (QRM) and ICH Q 10
(PQS)
Pharmaceutical Products Registration &
Facilities Licenses/Accreditation
Facing Regulatory audits and Preparation
of Compliance on Audit Observation and
related communication to the concerned
regulatory agencies (USFDA,MHRA,WHO
GENEVA, ANVISA,Etc,)
Computer System & Software Validation
Handling of Market Complaints, Recall and
Field alert Information (FAR)
Preparation of Risk assessment as per
Tools like FMEA,FMECA, FTA,PHA Etc,. As
per ICH
API Quality systems –ICH-Q7;APICS and EU
API;EDQM –CEP requirements
Preparation of US DMF and EU DMF;WHO
Geneva ASMF and Exhibit batches
execution.
Analytical & Bio-analytical Methods
Validation
Bioequivalence Studies Quality Assurance
Clinical trials Quality Assurance
ISO9001, ISO 14001 Implementation
Risk based Qualification of Equipments and
instruments IQ/OQ/PQ and project
Management
Risk based Process Validation as per New
USFDA and EMA requirements
Cleaning Validation and updating of
Product matrix
Handling of CAPA,. Change management,
Deviations, APQR, OOS, OOT, OOC, etc,.
Site Master File Preparation
Certified Internal Auditor for QMS ,RM/PM
Vendors, External laboratory and
Calibration agencies Audits
Certified Trainer for cGMP, GLP, GCP and
21CFR part 11 and Conducted more than 50
trainings
Regulatory Audits Management
21 CFR 210,211 andPart11 / ICH
Q7/TQM/GLP/GCP/GMP Implementation
QbD and Risk based Process validation and
Analytical Method validation.
Conducted Risk assessment for HVAC,
Water systems and Computerised systems,
Microbial practices and Sterility,
formulation facilities
Representative Experience:JOB Profile:
MEDLEY PHARMACEUTICALS (TIE UP WIth
MNC OF ZANZA,UK and APC UK)-from JAN2013
–FEB 2014) Worked as QA Head- GM-QA
Taking care of all cGMP and R&D technology
transfer work and Technical Quality Assurance
Activities compliance w.r.t GXP.GLP, GCP and GMP.
Handling all the client and national and
international Audits and its compliance ( Faced
,FDA Daman, KENYA,WHO –DCGI, and also Client
Audits like ZanZA Uk, Basi Potugal Bristol Germany
,etc,.) Training to all the staffs and operators
(More than 40 trainings conducted and also
Evaluation of effectiveness of the training
currently working on risk based process validation
Project leader LIMS implementation and its
Validation Systems Up gradation with respect to
Sops, QMS, Quality Manual and Related Forms
Regulatory updates and its impacts Pharmacopeia
updates and its impacts Cross functional team
member for Product recall, Failure Investigations
and CAPA effectiveness verification. OOS,OOT
investigations Quality Control Laboratory
improvement. ICH Q8,Q9 and Q10-
Implementation. Also working for USFDA,MHRA
and TGA audits USFDA exhibit batches
coordination nd excecution.
(More than 40 trainings conducted and also
Evaluation of effectiveness of the training currently
working on risk based process validation Project
leader LIMS implementation and its Validation
Systems Up gradation with respect to Sops, QMS,
Quality Manual and Related Forms Regulatory
updates and its impacts Pharmacopeia updates and
its impacts Cross functional team member for
Product recall, Failure Investigations and CAPA
effectiveness verification. OOS,OOT investigations
Quality Control Laboratory improvement. ICH
Q8,Q9 and Q10-Implementation.
Naari.AG-Offsite Work at Noida-. Swiss Based
MNC- (From Feb 2009 to Feb 2010.)
Worked as QA-Head (GM-Quality):New Analytical
laboratory designed and commissioned, qualified as
per standards, Implementation of cGMP, QMS
Systems, SOP Review, Qualifications of Equipments,
Hormone Manufacturing Facility Setup and its
Commissioning (API and Formulation) with Risk
assessment, Conduced cGMP Audits at
Manufacturing Facility, Conducted trainings on
cGMP,GLP and GCP, Preparation of BE studies
Protocol and its execution, Auditing CRO, Auditing
third party Facilities, Internal audits on API and
Formulation Facility
Pharmed Limited -–A unit of Bioplus UK PLC-
Delhi office (From Feb 2010-Feb 2011)

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ALKEM LABORATORIS LTD,DAMAN
(Period: From Feb 28,2011-Dec 2012)
Worked as QA Head-Audits and compliance and
taking care of all cGMP and Technical Quality
Assurance Activities compliance w.r.t GXP.GLP,
GCP and GMP. Handling all the client and national
and international Audits and its compliance (
Faced USFDA,MHRA,WHO Geneva, WHO –
DCGI,ANVISA and also Client Audits like TEVA,
Helm, Almus ,etc,.) Training to all the staffs and
operators
Clinigene International Ltd., Bangalore, (A
Biocon Company) India ( From July 2005-
Feb2009)
Worked as QA Manager(senior Level) responsible
for the maintenance of TQM, GCP,GLP as per OECD,
BA/BE guidelines of EMEA, UAFDA, WHO, ANVISA,
DCGI and Health Canada, conducted process based
and systems based ,final BA/BE report audits and
studies (All Phases of Clinical, Bio-analytical and
Statistical). Performed equipment validation
(DQ/IQ/OQ/PQ), analytical/bio-analytical method
validation, audits, SOP preparation and
verification. Conducted training to QA Team on
GLP, GCP and other Regulatory BA/BE guidelines.
Reviewed & approved all documents for regulatory
submission. Audited 48 Bio studies of international
and national customers. Watson LIMS, Waters
SDMS implantation, and Participated Empower,
Analyst Validation (LC-MS/MS).
Got best Team award from
Dr.Kiranmazumdarsaw (Biocon CMD) for
implementation of Phase I clinical trial Quality
systems
Got Best Documentation Award and Best PQ
Award from Thermo Fischer Scientific –USA (two
Consecutive Years) for Clinigene International
LimitedDAI-ICHI Karkaria Limited, Hyderabad
(Period:July2004 – June2005 ) Worked as Dy.
Manager, in-charge of the over QA, QC &
Regulatory Affairs requirements in filing DMF
as per ICH M4Q guidelines, filing USDMF as per
USFDA. Updated changes in USFDA, TGA,
MHRA & MCC and Implementation of
guidelines. Performed approval of raw
material, in-process & final product analysis.
Conducted training on analytical method
development, guidance on analysis and
calibration. Prepared Trend Analysis, Annual
product review and specifications & MOA’s of
samples for the new customer approval.
SSL-TTK Limited, India(Period: APRIL –2003 -
JULY-2004) Worked as QA Superintendent,
performed raw material, in-process, final product
and packaging material analysis. Prepared DQ/
IQ/OQ/PQ protocols, SOP’s/WI, and DMF filing.
Performed concurrent & retrospective process
Worked as QA Head-(GM Rank).Handling more than
17 third party contract manufacturing sites and
introduced more than 12 new types of formulations
in Indian market. Provide support to third party
activities regarding manufacturing, packaging,
control, storage and distribution comply with
quality standards Supports all technical details,
Clinical data required for marketing, Stability
studies and Quality assurance activities with
regulatory requirements.
Audited External Laboratory, Third Party cGMP
Audits,
NICHOLAS Piramal, India, Chennai
Period: July 2001- August 2002
Worked as QA & regulatory affairs officer,
responsible for raw material, in-process, final
product, packaging material & water analysis (As
per USP, BP, EP & IP). Prepared IQ/OQ/PQ
protocols, SOP’s/WI and DMF filing as per cGMP,
ICH guide lines. Conducted concurrent &
retrospective process validation for Cetrimide,
Chlorhexidine and Monsulfiram. Member of
Internal Auditor for cGMP. Performed stability
studies as per ICH guidelines, purified water
validation, BMR and MFR preparation for Bulk
Drugs. Prepared technical documents for regulatory
submission.
AMRUTANJAN LTD, Fine Chemicals Div., R
&D-Chennai
Performed well and this period is my starting
career and worked hard with all basics knowledge
learning
(Period: December 1995 – July 2001)
Worked as R&D Sr. Chemist,(Shift in charge)
performed raw material, In process & final product
packaging material, water analysis and effluent
Analysis. Performed process development and
analytical method development for assay and
related substances for APIs and Intermediates.
Conducted Analytical Method validation and
Handled All types of instrumentation like HPLC,GC,
IR,UV, NMR and all WET laboratory equipments.
Shasun Drugs-Pondicherry
(Trainee-period)
July 1994 –Dec 1995-Trainee
Worked as Trainee Chemist QC. Conducted Regular
QC Analysis for RM, Intermediates and in-process
Analysis of APIs.

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validation of HPLC), analytical method validation,
Internal Auditor for cGMP, and stability studies.
Worked on Change control & deviation for
facilities, production and stores. Performed Self-
inspection and audit as per US FDA 21 CFR part
210,211, BMR and MFR preparation for Bulk Drugs
and formulation, Cleaning Validation, ISO9001, ISO
14001 Audit and other related regulatory
concerns..
CIPLA Limited, Bangalore
Period: SEP- 2002- April2003)
Worked as QA Officer, responsible for concurrent,
prospective and retrospective process validation,
DMF filing as per USFDA guides lines. Preparation
of SOP’s, Process flow Charts for manufacturing,
and worked on change control & deviation, USFDA
related Audit work. One of the Audit team member
USFDA audit and achieved 0 483. Very Prestigious
Moment in my carrier as one of the Team Member
for this moment.
Qualifications:
Education Back Ground
1. M.Sc –Chemistry – Annamalai University -2004
2. B.Sc-chemistry-Loyola(Autonomous) College-1993
3. PG.Diploma in Industrial Water and Waste Water Treatment-2000-AlagappaUniversity
4. Diploma in computer Applications-1999
PROFESSIONAL TRAININGS AND CERTIFICATIONS
1. GMP training on API issued by Norman Franklin Inc, Germany-2002 at Bangalore
2. GMP Auditors Certification, Insight systems Inc,-2011 (three days course)
3. BA/BE auditing by Pinnacle health care -2007,Mumbai
4. GCP trainer certification course (three days )by Metropolis USA at Bangalore 2006
5. GLP training By Biocon ,Bangalore on 2007
6. ASQ-American Society of Quality-CQA Auditor model Exam(98%) -2013
7. Clinical trial Auditor course-Pinnacle Health Care Mumabi-2006
8. GCP Exam passed conducted by Pharma School UK-2008
9. SQA-Society of Quality assurance USA certificate for best poster-2008
10. Computer Systems Validation and USFDA 21CFRpart 11 compliance training –certified by
Dr.Ludwig Huber-compliance online.-2009
11. QbD trainer and implementation –Certificate issued by SSR college-Silvasa-2012
12. Trainer for drug regulatory and regulatory compliance procedures –certificate issued by SSR
college; silvasa 2012
13. Trainer/resource Person Certificate for conducting Stability and photo stability for drug Products
by SSR college;Silvasa;2013.
Articles Published:
1. Poster Presented in Title PP-23 ,Quality Assurance Programme in Clinical Bio analysis Event
Conducted by SQA - Society of Quality Assurance 24th Annual Meeting, USA.
Abstract Published in “Journal of Quality Assurance”- by Wiley Inter Science Magazine
2. Abstract on Title Pharmaceutical Site Master File accepted by BARQA – (British Association of Quality
Assurance),UK.
3. Poster presented on Title PP-27 “ Details on Preparation of Site Master file for Pharma Industry
” –Event Conducted by SQA and Abstract Published in “Journal of Quality Assurance”- by Wiley
InterScience Magazine.USA

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4. Abstract published on title The Challenges of Implementing a Centralized Change Control
Management System -cGMP and GLP- Event conducted by SQA and abstract published in “Journal
of Quality Assurance”- by Wiley InterScience Magazine.USA
5. Abstract published on title GLP Document archival - Event conducted by SQA and abstract
published in “Journal of Quality Assurance”- by Wiley InterScience Magazine.USA.
6. Presented Instrumentation and Method Validation Challenges in Bio Analysis and how to
mitigate Validation Risks –Work shop conducted By Chromatographic society of India, Mumbai
on Nov,8th 2011.
7. Presented DMF Registration With Regulatory agencies as part of Quality Improvement
programme at SSR College of pharmacy, SIlvasa, India as sponsored by Pune University
8. Presented QRM roles in QbD in Quality by Design National Level Work Shop at SSR College of
pharmacy, SIlvasa, India as sponsored by Pune University
9. Presented On Photo stability studies and its compliance in SSR college Silvasa, Feb 2014,
10. Presented on Recent Regulatory Requirements on Analytical Laboratories compliance, QBD
Roles in GXP Application in Analytical Method development, Analytical Instrument
Qualifications –USP at Pharma Summit 2014, Mumbai.
Publication as co –author:
Rathnakar, K.Chandramohan, Hemanth kumar, G.Sundar, Viny Sam, N.Satish, Shrinivas S.Savale and
A.S.Arvind, “A simple, rapid and sensitive LC-MS/MS method for estimation of Alfuzosin in
human plasma using Doxazosin as an internal standard” at 58th Indian Pharmaceutical Congress,
2006, Mumbai, India.
Viny Sam, Satish N., Hemanth kumar, K.Chandramohan, P.Rathnakar, Tarunveer Singh, G.Sundar,
Shrinivas S.Savale and A.S.Arvind, “A simple and sensitive HPLC assay for estimation of
Voriconazole in human plasma” at 58th Indian Pharmaceutical Congress, 2006, Mumbai, India.
K.Hemanth Kumar, V.A.Sam, P.Rathnakar, K.Chandramohan, S.S.Savale, G.Sundar, T.Singh, S.Nagraj
and A.S.Arvind, “Sensitive and specific liquid chromatography-tandem mass spectrometric
method (LC-MS/MS) method for estimation of Digoxin in human serum” at British
Pharmaceutical Conference, 2007, Manchester, UK.
K.Chandramohan, P.Rathnakar, S.S.Savale, K.Hemanth kumar, V.A.Sam, G.Sundar, T.Singh, S.Nagraj
and A.S.Arvind, “Sensitive and simple liquid chromatography-tandem mass spectrometric
method (LC-MS/MS) method for estimation of Valsartan in human plasma” at British
Pharmaceutical Conference, 2007, Manchester, UK.
Shrinivas Savale, Viny Sam, Hemanth Kumar, Kandasamy Chandramohan, Palarapu Rathnakar,
Tarunveer Singh, Sundar Ganesan and Atignal Arvind, “Sensitive and simple liquid
chromatography-tandem mass spectrometric method (LC-MS/MS) method for simultaneous
estimation of Fosinopril and Fosinoprilat in human plasma” at AAPS Annual Meeting and
Exposition, 2007, San Diego, CA, USA.
Shrinivas Savale, Viny Sam, Hemanth Kumar, Kandasamy Chandramohan, Palarapu Rathnakar,
Tarunveer Singh, Sundar Ganesan and Atignal Arvind, “Simple and sensitive liquid
chromatography-tandem mass spectrometric method (LC-MS/MS) method for estimation of
Tacrolimus in human whole blood” at AAPS Annual Meeting and Exposition, 2007, San Diego, CA,
USA.
P.Rathnakar, K.Chandramohan, S.S.Savale, T.Singh, Anju Mary John, V.A.Sam, G.Sundar and A.Arvind,
“Simple and sensitive liquid chromatography-tandem mass spectrometric method (LC-MS/MS)
method for estimation of Balsalazide in human plasma” at 19th International symposium on
Pharmaceutical and Biomedical Analysis, 2008, Poland.
P.Rathnakar, K.Chandramohan, S.S.Savale, T.Singh, Anju Mary John, V.A.Sam, G.Sundar and A.Arvind,
“Simple, sensitive and robust method for estimation of Cetirizine in human plasma” at 19th
International symposium on Pharmaceutical and Biomedical Analysis, 2008, Poland.
Rathnakar P., Savale S.S., Sundar G., Riken Sanghvi, Tarunveer Singh and Hariharasudhan B., “A
Simple and sensitive LC-MS/MS method for estimation of Ziprasidone in human plasma” at
19th International symposium on Pharmaceutical and Biomedical Analysis, 2008, Poland.
R.Palarapu, C.Kandasamy, S.Savale, V.Sam, S.Ganesan and A.Arvind, “A Simple, rapid and sensitive
LC-MS/MS method for estimation of Oxybutynin and its metabolite, desethyloxybutynin in
human plasma” at AAPS Annual Meeting and Exposition, 2008, Atlanta, USA.
V.Sam, R.Palarapu, S.Savale, C.Kandasamy, H.Bose, A.John, S.Ganesan and A.Arvind, “Development
and validation of simple, sensitive and robust method for estimation of Nimodipine in human
plasma” at AAPS Annual Meeting and Exposition, 2008, Atlanta, USA.