GMP Pharma Institute Private Limited

Business Presentation

About Us

GMP Pharma Institute Private Limited was established in 2004, with its

original name as Pharma Institute of GMPs (PIGMP).

1. Main objective: Training services - Organized several Conferences,

Seminars, Workshops for pharma professionals.

2. PIGMP is a registered private limited company with its title as GMP

Pharma Institute Private Limited .

3. Operations expanded in areas of Consultancy Services and Auditing with

a number of Indian as well as International companies.

4. GMP Pharma Institute Private Limited is today the most sought after

multi-source organization for above services.

5. Based at Dehradun, in Uttarakhand state, India.

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Our Strength at PIGMP

Total strength of technical staff: 24

Directors: 4

Technical consultancy staff: 12

Support staff: 3

Sundry staff: 5

Our Technical Associates (for audits, training, validation): 11

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Europe Office

GMP Pharma B V Netherlands, at Amsterdam

(established 2012)

GMP Pharma BFF, at Barcelona, Spain

(established 2014)

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OUR CORE SERVICES

Training services

Consultancy services

Manufacturing

Validation services

Regulatory services

Auditing services

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OTHER SERVICES

GMP solutions

Regulatory solutions

Documentation Support

PIGMP Membership

Quality Culture Change

Competency & Skills

Development

TRAINING SERVICES

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•PIGMP holds an esteem position in offering training services of various types with its array of experts.

•Several training programs in the form of conferences,

seminars and workshops organized in different cities of India and abroad.

•PIGMP specializes in In-house training programs for companies who are interested in customized programs at their site.

TRAINING SERVICES

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• Facility Designing

• Process Development

• Quality By Design

• Quality Risk Management

• Quality Management Systems

• Qualifications & Validations

• Importance of GMPs & Regulatory

• Six GMP systems

• Regulatory submissions & inspections

• ICH & other Regulatory guidelines

• Technology Transfer (Process/Analytical)

• Aseptic Processing & Techniques

• Microbiological Practices

• Data Integrity & Documentation Practices

• HVAC & Water systems Regulatory & GMP

audits for compliance

• Sterilization processes

• Lab Controls & Lab Compliance

• Advanced Mfg & Analytical technology

• Behavioral Aspects of Compliance

• Being Sensitive to Compliance

• Developing Competency Skills

• Training the Trainers for GMPs

• Training the Auditors for GMPs

TRAINING SERVICES

PIGMP offers training programs in the following areas (not all inclusive):

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√ Sumant Baukhandi, PhD • 37 years of training experience.

• More than 7600 seminars presented, till January 2016

• Certified trainer from GMP Institute, Kentucky, USA (1995).

√ Associate Trainers • Other Specialist Trainers with years of training experience are

associated with PIGMP.

SPECIALIST TRAINERS OF PIGMP

CONSULTANCY PROJECTS

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CONSULTANCY SERVICES

• Facility Designing

• HVAC & Water Systems

• Equipment Selection & Layout

• Risk Evaluation & Mitigation

• Qualifications & Validations

• GMP Systems & Solutions

• GMP & Regulatory Audits

• Technical Due Diligence Audits

• Documentation Systems

• Data Integrity

• Technology Transfers

• Regulatory dossiers & Solutions

• Aseptic Processing

• Sterilization Processes

• Microbiology Practices

• Manufacturing & Analytical Processes

• GLPs & Toxicology

• Medical Devices

PIGMP offers consultancy services in the following areas:

PIGMP is a reputed brand name in Pharma consultancy with many SMEs and large companies in its list of clients. We offer following consultancy services to the pharmaceutical / biopharmaceutical / biotechnology / medical devices industry:

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CONSULTANCY SERVICES

• Facility Designing

• Equipment & Machinery Selection

• Layout - Drawings

• Engineering Project Report

• Risk Evaluation & Mitigation in Design

• Installation & Commissioning

• Qualifications & Validations

• GMP Systems & Solutions

• Technical Due Diligence Audits

• Water Purification Systems

• HVAC Systems

• Steam Systems

• Electrical Engineering

• Instrumentation Engineering

• Civil Engineering

• Pharmaceutical Mfg facilities

• API Mfg facilities

• Laboratory facilities

• Documentation Systems

PIGMP offers consultancy services in the following Engineering projects:

PIGMP has helped in green field projects as well as new expansions of manufacturing facilities and laboratories:

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CONSULTANCY SERVICES

PIGMP has helped in green field projects as well as new expansions of manufacturing facilities and laboratories:

PIGMP has helped in designing following facilities:

47 Oral Solid Dosage facilities,

54 Aseptic processing injection facilities,

21 Aseptic lyophilization facilities,

8 Hormones facilities,

6 Vaccines facilities,

52 API facilities,

6 Medical devices facilities,

6 Oncology facilities, and

3 Steroids facilities

VALIDATION SERVICES

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VALIDATION SERVICES

• Temperature/RH mapping (rooms + chambers)

• Facility Qualification

• Equipment Qualifications

• Stability Chambers - Qualifications

• HVAC & LAF systems

• Water systems

• Nitrogen Generators

• Compressed Air Systems

• Steam Systems

• Process Validations

• Container – Closure Integrity

• Aseptic processing - Media Fills

• Sterilization process validations

• Lyophilizers & Lyophilization process

• Analytical Method Validations

• Microbiology related Validations

• Computerized Systems Validation

We offer validation services to Pharma companies in:

AUDITING SERVICES

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AUDITING SERVICES

• Facility Audit (Manufacturing – R&D – Laboratories – Utilities)

• GMP Systems’ Audit

• Regulatory Compliance Audit

• Pre-Inspection Audit

• Gap Analysis Audits

• Risk Evaluation Audit

• Documentation Audit

• Failure Investigation Audit

• Trouble Shooting Audit

• Technical Due Diligence Audit

• Vendor Audit

PIGMP conducts audits of various pharmaceutical companies in the following areas:

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AUDITING SERVICES

• Technical Due Diligence Audit

• GMP Systems’ Compliance Audit

• Regulatory Compliance Audit

• Pre-Inspection Audit – Gap Analysis

• Vendor Audit

We conducts audits in India and overseas for sponsor companies for the purpose of:

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AUDITING SERVICES

85 API manufacturing facilities,

123 Dosage Forms manufacturing facilities,

17 Biopharmaceuticals manufacturing facilities, and

6 Medical devices manufacturing facilities.

In all 231 facilities were audited till-date (January 2016)

We have also audited 143 ANDAs, 112 US + COS DMFs, 33 EU - MAA

Submissions, 6 BLAs of client companies.

We have conducted several audits in India and overseas for sponsor companies :

REGULATORY SERVICES

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REGULATORY SERVICES

• PIGMP specializes in Regulatory process of dossiers preparation, adequacy reviews, submissions, responses to regulatory queries and responses to regulatory audits.

• We also offer consultancy to help obtain Regulatory approvals / certifications from various regulatory agencies.

• We have expertise in preparation and review of:

1. DMFs for all agencies as well as customers.

2. ANDAs for US-FDA.

3. ANDS for Canada

4. Marketing Authorization Applications to EU national authorities.

5. Site Master Files ( SMF & ASMF)

6. Submissions for medical devices

7. Biological License Applications

8. TSE/BSE Certification Applications

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REGULATORY SERVICES

• PIGMP specializes in reviews of Regulatory dossiers for adequacy, prior to submissions.

DMFs,

ANDAs,

BLAs,

Veterinary applications,

The review of dossiers can be performed by PIGMP experts at your company site or off-site.

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REGULATORY SERVICES

• PIGMP has helped several companies in preparing, reviewing and submitting regulatory dossiers:

• Regulatory Dossiers prepared & submitted: 126 DMFs

98 ANDAs

59 EU Marketing Authorization Applications

6 BLAs

All dossiers are prepared in ICH CTD / eCTD formats as per agency requirements.

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REGULATORY SERVICES

• PIGMP has helped several companies in obtaining Regulatory approvals / GMP certifications.

• Regulatory Approvals: 98 ANDA approvals from US-FDA,

25 MHRA certifications,

17 EU – GMP certifications

23 TGA certifications,

36 EDQM certifications,

10 ANVISA certifications,

11 WHO-Geneva certifications, and

7 MCC S. Africa certifications.

(Total: 227 approvals till-date)

The services can be provided by PIGMP experts at your company site.

GMP SOLUTIONS

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GMP SOLUTIONS

• The GMP Pharma Institute Private Limited is pleased to provide GMP solutions to the pharmaceutical industry on areas related to

APIs, Drug Products, Bio-pharmaceuticals, Biotechnology and medical devices.

• PIGMP with its experienced team of experts and technical associates is geared to respond to the industry’s practical problems which are encountered regularly. Where others may not have an answer to your problems, PIGMP guarantees that it will definitely have a resolution to all.

• Since our experts come from industry with loads of hand-on experience, we know where people might go wrong and consequently, we know the root cause.

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• Warning Letters Remediation

• GMP Compliance,

• Regulatory Compliance,

• Regulatory responses,

• Data Integrity

• HVAC systems,

• Water systems,

• Other Utility systems,

• Contamination,

• Qualifications & Validations,

• Aseptic Processing,

• Sterility & Endotoxin Failures,

• Sterilization processes,

• Documentation,

• Microbiology procedures,

• Computerized Systems,

• Laboratory related.

Key GMP Solution Areas: The key areas in which intelligent and quick solutions can be provided for problems faced by companies include:

GMP SOLUTIONS

WHY SHOULD YOU USE PIGMP SERVICES ?

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WHY PIGMP SERVICES ?

• PIGMP has acquired a brand name in the Pharma industry over the years with its highly satisfied clients in India and internationally.

• PIGMP has an experienced team of experts from all fields to cater to APIs, drug product formulations, bio-pharmaceuticals, biotechnology, fermentations and medical devices.

• We highlight some special features of PIGMP which make it as one stop organization for all your requirements.

• We provide guidance & advice on:

a. Facility designing - based on Risk, Science, Engineering, GMP & Regulatory

requirements (more than 203 facilities designed so far).

b. QA & QC – to strengthen the organization’s Quality systems that drive results;

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WHY PIGMP SERVICES ?

c. GMPs – based on QRM, QMS and the six GMP systems of inspections to satisfy the continuous state-of-compliance; d. Regulatory – to enable you to understand the regulations in force in different parts of the world, to help in regulatory submissions, inspections and approvals;

e. Validation – to facilitate the process of successful Qualifications of facility & equipment as well as Validations of various systems & processes including Cleaning processes, Sterilization processes, Aseptic processing and Computerized systems;

f. Systems & Documentation – to enable you to develop & enhance the practice of SOPs, documentation process & compliance records; We help in acquiring special skills to maintain data integrity.

g. Compliance & Auditing – to help in enhancing GMP & Regulatory compliance levels and to clear all Regulatory & Customer audits for approvals.

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h. Microbiology – to understand the fundamentals of the science and its practice as per pharmacopoeia & regulatory requirements to enable enhanced GMP compliance;

i. Aseptic processing – to provide clarity of the type, degree and levels of GMPs & behavioral practices required for sterile medicinal products processing; j. Sterilization & Sterility – to understand the science, GMP & Regulatory

requirements for compliance; and k. Technology Transfer – to provide assurance of reproducing the product, process

and product quality as pre-determined. l. Quality by Design systems. We also provide Training to companies based on their training needs at site to

enable them to seek clarity and understanding of the GMPs & Regulatory processes in all areas of activity.

WHY PIGMP SERVICES ?

TRAINING PROGRAMS ORGANIZED BY PIGMP

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TRAINING PROGRAMS ORGANIZED BY PIGMP

1. Microbiology in Support of Pharmaceutical Manufacturing – Beyond the

Obvious (November 2004, Chennai)

2. Surviving Challenges of Validations in Aseptic Processing and Sterilizations

(May 2005, Mumbai)

3. Technology Transfer – Conceptualization to Commercialization (July 2005, New Delhi)

4. Laboratory Controls & Laboratory Compliance – A Game-plan (February

2006, Mumbai)

5. Workshop on" Validation Week (October 2006, Chandigarh)

6. Microbiology in Support of Pharmaceutical Manufacturing – Beyond the Obvious Part II (October 2006, Mumbai)

7. Indo-Europe API Forum – Basel, Switzerland (November 2006, Basel)

8. New Challenges in Regulatory Submissions – US & EU Scenarios (December

2006, Indore)

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9. Workshop on Good Documentation Practices (January 2007, Dehradun)

10. Workshop on “septic Processing – Assuring Sterility (February 2007,

Pune)

11. Latest Technologies – HVAC & Water Systems (March 2007, Amman,

Jordan)

12. Latest Technologies – Water for Pharmaceutical Use (March 2007,

Hyderabad)

13. Surviving Challenges of Regulatory Inspection – Achieving Success (April 2007, Ahmedabad)

14. Microbiological Practices in the Pharmaceutical Industry (June 2007, Dehradun)

15. Conference on Laboratory Control & Laboratory Compliance – A Game plan to Success (September 2007, Chennai)

TRAINING PROGRAMS ORGANIZED BY PIGMP

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16. 5-day Conference cum workshop: Validation week ( June, 2008 - Chandigarh)

17. Conference on Aseptic Processing and Regulatory Documentation (August, 2008- Goa)

18. Training workshop on Competency development in GMPs & Regulatory Compliance (April, 2009- Pune)

19. Conference on Current Trends in Aseptic Processing – A risk based approach (June,2009- Indore)

20. Workshop on Good Engineering Practices (November, 2009 – Hyderabad) 21. Workshop on "Handling Deviations and C“P“ (November, 2009 –

Dehradun) 22. Workshop on "Validation Week (February 2010 – Aurangabad) 23. Process Validation & Product Quality Review (March, 2010 – Chandigarh) 24. Training Program on Current Trends in Stability Studies (March, 2010 –

Dehradun) 25. Three-day Training Program on GMP – GDP for QC-QA personnel for

Aurobindo (April 2010 – Hyderabad).

TRAINING PROGRAMS ORGANIZED BY PIGMP

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26. Training workshop on Competency development in GMPs & Regulatory Compliance (May, 2010 - Hyderabad).

27. Training Program on Handling Deviations and Leveraging C“P“ (May, 2011 – Panchkula).

28. Training Program on New GMP Initiatives (May 2011 – Navi Mumbai).

29. Training Program on ”asic GMPs in Vaccines Manufacturing (September

2011 – Pune).

30. Training Program on Utilization of Statistical tools in Process Control

(November 2011 – Chennai).

31. Training Program on "Handling Deviations and C“P“ (January 2012 –

Amsterdam )

32. Training Program on Quality by Design and Regulatory Perspective

(February 2012 – Bangalore).

33. Training Program on Execution and Packaging of Exhibit batches (May

2012 – Mumbai).

TRAINING PROGRAMS ORGANIZED BY PIGMP

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34. Training Program on Sterilization processes and Validation concepts (August 2012 – New Delhi).

35. Training Program on Competency development in GMPs & Regulatory Compliance (September 2012 – Singapore).

36. Training workshop on Good Documentation Practices (October, 2012 - Hyderabad).

37. Training workshop on Challenges of Compiling a Regulatory Dossier (December 3 – 4, 2012, Brussels).

38. Training Program on Developing, Processing, Packaging Controls - Regulatory Perspective (December 17 – 18, 2012, Pune).

39. Quality – Culture of Compliance Training program in Ranbaxy since January 2013;

40. Two-day Workshop on Statistical Applications in Pharmaceutical Manufacturing (March 2013 – Singapore)

TRAINING PROGRAMS ORGANIZED BY PIGMP

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41. Two-day Workshop on Data Integrity and Reliability (May 2013 – Bangalore) 42. Three-day Training Workshop on Train-the-Trainers for GMPs for Ranbaxy

(July 2013 - Indore) 43. Three-day Workshop on Train-the-Trainers for GMPs for Wockhardt

(November 2013 - Aurangabad) 44. Three-day Training Program on Good Engineering Practices – Regulatory

Expectations for Wockhardt (December 2013 - Aurangabad) 45. Three-day Training Program on Good Engineering Practices – Regulatory

Expectations for Wockhardt (February 2014 - Aurangabad) 46. Two-day Training Program on Wisdom of Compliance Through ICH Q10

(February 2014 – Singapore). 47. Three-day Training Program on GMP – GDP for QC-QA personnel for

Ranbaxy (June 1st week, 2014 – Mohali). 48. Three-day Training Program on GMP – GDP for QC-QA personnel for

Ranbaxy (June 4th week, 2014 – Mohali). 49. Three-day Training Program on GMP – GDP for QC-QA personnel for

Ranbaxy (August 2014 – Toansa).

TRAINING PROGRAMS ORGANIZED BY PIGMP

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50. Two-day Workshop on “voiding Data Integrity and Reliability Issues (October 9-10, 2014 – Indore)

51. Two-day Training Seminar on “septic processing of sterile “PIs (November 20-21, 2014 – Mumbai).

52. Two-day Workshop on Training the Auditors for GMPs (Dec, 2014 - Pune). 53. Two-day Workshop on Compliance through Competence (January 9-10,

2015, Ahmedabad). 54. One-day Seminar on Quality by Design in Nectar Lifesciences, Chandigarh

(January 16, 2015).

55. Two-day Training Workshop on Stability Studies in Nektar Therpeutics, Hyderabad (August 7-8, 2015).

56. One-day Seminar on Current Regulatory Challenges in Hotel Taj West End, Bangalore (August 25, 2015).

57. Two-day Training program on ”uilding Data Integrity & Data Reliability in Hotel Lalit Palace, New Delhi (25-26 September 2015)

58. Two-day Training program on Facing Challenges of Regulatory Inspections in Hotel Le Meridien, Mumbai (23-24 November, 2015)

TRAINING PROGRAMS ORGANIZED BY PIGMP

PIGMP CLIENTELE

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PIGMP CLIENTELE

• Akums (Consultancy)

• Aurobindo Pharma (Training)

• Baring Private Equity Partners (Audits)

• Bharat Serums (Training)

• Biocon (Training)

• Centaur Pharmaceuticals Ltd (Consultancy)

• Cipla (Training)

• Dr. Reddy’s Laboratories Training

• Eisai Manufacturing Tech. (Consultancy)

• Elder Pharmaceuticals Ltd (Consultancy)

• Emcure Pharmaceuticals Ltd

• Famy Care (Consultancy)

• Fresinius Kabi (Audits)

• Getz Pharma, Karachi (Consultancy)

• Gland Pharma (Training, Audits)

• Glenmark Pharmaceuticals Ltd (Training)

• Granules India Pvt Ltd (Audits & Training)

• India Glycols Limited (Consultancy)

• Ind-Swift Labs (Training)

• Indoco Remedies (Auditing)

• Jagsonpal (Consultancy)

• Johnson & Johnson (Training)

• Jubilant Organosys (Audits & Training)

• Kemwell Pharmaceuticals (Consultancy)

• Lupin (Training)

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PIGMP CLIENTELE

• Marck Biosciences (Consultancy)

• Marksons Limited (Consultancy)

• Medreich (Training)

• Microlabs (Audits & Training)

• Naari (Consultancy)

• Nectar Lifesciences (Consultancy)

• Nicholas Piramal (Audits & Training)

• Novartis Vaccines, USA (Audits)

• Orchid Chems & Pharmaceuticals (Training)

• Orchid Health Care (Audits & Training)

• Panacea Biotec (Audits & Training)

• Parabolic Drugs Ltd (Consultancy)

• Ranbaxy Laboratories (Audits & Training)

• Sandoz, India (Audits & Training)

• Serum Institute (Training)

• Sharon Bio-Medicines (Consultancy)

• SIDMAK Pharmaceuticals Ltd (Consultancy)

• Surya Pharma Limited (Consultancy)

• Synbiotec (Audits)

• Torrent Pharma (Audits & Training)

• USV Limited (Audits & Training)

• Wockhardt (Audits & Training)

• Xellia, Denmark (Audits)

• Pharmaceuticals Producers, Canada (Audits)

For Business Enquiries Please contact

Sumant Baukhandi, PhD Managing Director

GMP Pharma Institute Private Ltd, Mobile Number : +91 999 70 10 901

Board line Number : +91- 135- 64 54 916

E-mail : pigmpinstt@gmail.com

Website: www.pigmp.org

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GMP PHARMA INSTITUTE PRIVATE LIMITED

GMP Pharma Institute Private Limited Near Sudhowala Chowk, SelaQui Road,

Dehradun – 248 007,

Uttarakhand (India)

www.pigmp.org