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Role of IT in Pharma Industry
Dr. Ambekar Abdul Wahid
M. Pharm; Ph. D
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vilad Ghat; Ahmednagar (MS)
6/16/2021 1
• India is now among the top five emerging pharmaceutical
markets globally.
• And is a front runner in a wide range of specialties
involving complex drugs manufacture, development
and technology.
• The Indian pharmaceutical industry is a highly knowledge
-based industry which is growing steadily and plays a
major role in the Indian economy.
• (Last fiscal year, the sector contributed around 1.72 % to
the country’s GDP)
• Export: Drugs and pharma product 24.89% till
September 2020
6/16/2021 2
• In recent decades, technology has transformed
the way of life.
• It has influenced every sector of human life,
from communication, transport,
manufacturing, business with the medical and
pharmaceutical industry as a front-runner
beneficiary.
• Pharmacists are using the IT systems in the
modern age to build and formulate their daily
work more efficiently and effectively.
6/16/2021 3
Role of Engineers in Pharmaceutical Industry
 Designing, building and improving manufacturing
facilities that produce drugs.
 Handle increasingly complex GMP demands to
ensure the medicine produced is safe for patients.
 GMP consideration are vital in all design phases.
 From early conceptual design to the
implementation and execution of pharmaceutical
quality systems.
6/16/2021 4
Pharmacy Informatics
 Application of IT systems in Pharmaceutical industry
is called as PHARMACY INFORMATICS
 The scientific field that deals with biomedical
information, data and knowledge – their storage,
retrieval and optimal use for problem solving and
decision-making.
 It is tightly focused on the optimal use of drug
information for problem-solving, decision making and
promoting safe pharmaceutical care.
6/16/2021 5
Importance in Pharma Industry
 Preventing medication errors
 To interconnect clinicians
 Decrease the manual work
 To smoothen the work- flow
 To develop strict security and to reduce paper work
(e-documentation and e-marketing)
 Complete automation of manufacturing, accounting
and distribution processes.
6/16/2021 6
Role in Medical Store Management
Pharmacy management software help pharmacist:
 Help pharmacist to manage Purchase.
 Help pharmacist to manage Purchase return.
 Help pharmacist to manage Sale.
 Help pharmacist to manage Sale return.
 Help pharmacist to manage Short items.
 Help pharmacist to manage expiry date product
effectively.
Pharmacy management software are fully automated
which will help reduce the burden of the pharmacist
and increase revenue.
6/16/2021 7
Top 10 Popular Medical Store Software
• Marg Chemist Software
• PharmSoft
• Medica
• Pharmiz
• Visual Chemist
• LogicPharma
• CBO
• Clinicea
• hCue
• Gofrugal
6/16/2021 8
Role in Hospital Pharmacy
Computerized Physician Order Entry (CPOE)
 Include both inpatient orders and the electronic ordering
of outpatient prescriptions often referred to as e-
prescribing.
 Allows physicians & other caregivers input orders directly
into a computer, thereby eliminating problems with
handwriting legibility and order transcription.
 Physician can make good clinical decisions based on e-
records of patients.
 Bar-coded medication administration: System alerts the
nurse to any mismatch of patient identity or of the name,
dose, or route of administration of the medication.
6/16/2021 9
6/16/2021 10
6/16/2021 11
6/16/2021 12
CPOE helps in
• Order entry into the pharmacy information
system.
• Online order verification by pharmacist
• Computerized warnings for drug allergies.
• Inappropriate doses.
• Drug-drug interactions.
• Computer-supported medication supply and
distribution.
• Automated label generation.
• Computerized pharmacy billing.
6/16/2021 13
Computerized Physician Order Entry
(CPOE)
6/16/2021 14
Role in Pharmaceutical Industry
1. Management of data:
Enterprise Resource Planning (ERP):
 An ERP system integrates all data and processes of
an organization.
 The purpose of ERP is to facilitate the flow of
information between all business functions inside
the boundaries of the organization and manage the
connections to outside stakeholders.
6/16/2021 15
ERP consists of various modules
• Production and inventory management
• Weighing and dispensing
• E-batch records
• E-packaging records
• Financial accounting
• Personnel management
• Training and development
6/16/2021 16
2. Management of laboratory information:
Laboratory Information Management System (LIMS)
• It manages the information flow within the lab and
can be the modus operandi of connecting the lab with
the rest of the organization.
• Automates lab processes to increase productivity,
efficiency and quality in analysis.
• More important is that, it takes care of 70% of
laboratory guidelines, what we called as GLP
6/16/2021 17
Role in Pharmaceutical Industry
It helps from:
• Sample request to sample registration
• Sample collection
• Automatic calculations of tests methods
• Specification maintenance
• Assigning properties to those tests
• Recording results, generating reports
• Issuing COA’s (Certificate of Analysis)
6/16/2021 18
3. Customer Relationship Management (CRM)
Sales Force Automation (SFA) Software
• SFA are information systems used in CRM that helps to
automate some sales and sales management functions.
• It is a system that automatically records all the stages in a
sales process.
• It manages data, controls on-line movement of goods and
manpower, including distribution network for pharmaceutical
marketing
6/16/2021 19
Role in Pharmaceutical Industry
It automates all the areas starting from
• On-line records
• Doctor visit reports
• Tour plans and approvals,
• Sales summaries & Booking sales orders
• Expense details & stockiest inventory
6/16/2021 20
4. Management of manufacturing and packing records
Electronic Batch Records (EBR) Software
• It is a software for on-line management of batch
manufacturing and packaging records.
• It converts the bulky documentation work into very
centralized automatic version.
• EBR aggregates data from across various departments and
summarizes it into one consolidated record for the lot
produced.
6/16/2021 21
Role in Pharmaceutical Industry
It performs following functions
• Secured document management
• Checks data integrity
• Performs automatic calculations
• Automatic audit trail
• Other control measures to help ensure compliance with
21 Cost and Freight (CFR) Part 11 regulation.
6/16/2021 22
1. Drug Discovery
 Drug Design:
A) Target protein structure prediction
B) Drug protein interaction study
 Drug Screening
A) Bioactivity predication
B) Toxicity predication
C) Physicochemical properties predication
2. Pharmaceutical product development
A) Aid in deciding suitable exceptions
B) Monitoring and modifying development process
C) Ensuring in-process specification compliance
6/16/2021 23
Role in Research and Development
3. Pharmaceutical manufacturing
A) Automated manufacturing
B) Correlating manufacturing errors to set parameters
C) Personalized manufacturing
4. Quality Assurance and Quality Control
A) Understanding critical process parameter
B) Guide future production cycle
C) Regulation of in-line quality
D) Ensure QA with aid of Electronic Laboratory Notebook (ELN)
and other techniques
6/16/2021 24
Role in Research and Development
5. Clinical trail design and monitoring
A) Subject enrollment or selection
B) Patient drop out
C) Monitoring of trails
6. Pharmaceutical product management
A) Market positioning
B) Market prediction and analysis
C) Product coasting
6/16/2021 25
Role in Research and Development
Some of the software use in pharmaceuticals
Research & Development
• ChemDraw: With its origins as a chemical drawing tool,
ChemDraw has evolved steadily to become the leading
chemically-intelligent solution for multiple disciplines from
specialty chemistry to pharmaceutical drug discovery.
• AutoDock: It is designed to predict how small molecules,
such as substrates or drug candidates, bind to a receptor of
known 3D structure.
• CDD Vault: It helps project team manage, analyze and
present chemical structures and biological assay data.
6/16/2021 26
• adWATCH: Helps pharmaceutical organizations manage and
report adverse events that occur during clinical trials.
• Virtual Labs: Initiative by Ministry of Education, Government
of India with an aim to provide remote-access to Labs in
various disciplines of Science and Engineering.
6/16/2021 27
Summary
To sum up…
• High competition, less time to reach the market and a
highly regulated environment have forced Indian
pharma companies to adopt advanced and latest IT
and automation solutions.
• In the recent years, there has been a significant rise
in the use of computer related systems in the
pharma industry.
6/16/2021 28
• Many industries have got most of their operations
computerized.
• Not just the big pharma companies, but even about
70% of the small and medium enterprises utilize
automation in one form or the other.
• Software systems are being increasingly accepted
as an essential part of a modern and progressive
pharma industry.
6/16/2021 29
Summary (Continue….)
Questions?
6/16/2021 30
6/16/2021 31

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Role of IT in the Pharma Industry

  • 1. Role of IT in Pharma Industry Dr. Ambekar Abdul Wahid M. Pharm; Ph. D Dr. Vithalrao Vikhe Patil Foundation’s College of Pharmacy Vilad Ghat; Ahmednagar (MS) 6/16/2021 1
  • 2. • India is now among the top five emerging pharmaceutical markets globally. • And is a front runner in a wide range of specialties involving complex drugs manufacture, development and technology. • The Indian pharmaceutical industry is a highly knowledge -based industry which is growing steadily and plays a major role in the Indian economy. • (Last fiscal year, the sector contributed around 1.72 % to the country’s GDP) • Export: Drugs and pharma product 24.89% till September 2020 6/16/2021 2
  • 3. • In recent decades, technology has transformed the way of life. • It has influenced every sector of human life, from communication, transport, manufacturing, business with the medical and pharmaceutical industry as a front-runner beneficiary. • Pharmacists are using the IT systems in the modern age to build and formulate their daily work more efficiently and effectively. 6/16/2021 3
  • 4. Role of Engineers in Pharmaceutical Industry  Designing, building and improving manufacturing facilities that produce drugs.  Handle increasingly complex GMP demands to ensure the medicine produced is safe for patients.  GMP consideration are vital in all design phases.  From early conceptual design to the implementation and execution of pharmaceutical quality systems. 6/16/2021 4
  • 5. Pharmacy Informatics  Application of IT systems in Pharmaceutical industry is called as PHARMACY INFORMATICS  The scientific field that deals with biomedical information, data and knowledge – their storage, retrieval and optimal use for problem solving and decision-making.  It is tightly focused on the optimal use of drug information for problem-solving, decision making and promoting safe pharmaceutical care. 6/16/2021 5
  • 6. Importance in Pharma Industry  Preventing medication errors  To interconnect clinicians  Decrease the manual work  To smoothen the work- flow  To develop strict security and to reduce paper work (e-documentation and e-marketing)  Complete automation of manufacturing, accounting and distribution processes. 6/16/2021 6
  • 7. Role in Medical Store Management Pharmacy management software help pharmacist:  Help pharmacist to manage Purchase.  Help pharmacist to manage Purchase return.  Help pharmacist to manage Sale.  Help pharmacist to manage Sale return.  Help pharmacist to manage Short items.  Help pharmacist to manage expiry date product effectively. Pharmacy management software are fully automated which will help reduce the burden of the pharmacist and increase revenue. 6/16/2021 7
  • 8. Top 10 Popular Medical Store Software • Marg Chemist Software • PharmSoft • Medica • Pharmiz • Visual Chemist • LogicPharma • CBO • Clinicea • hCue • Gofrugal 6/16/2021 8
  • 9. Role in Hospital Pharmacy Computerized Physician Order Entry (CPOE)  Include both inpatient orders and the electronic ordering of outpatient prescriptions often referred to as e- prescribing.  Allows physicians & other caregivers input orders directly into a computer, thereby eliminating problems with handwriting legibility and order transcription.  Physician can make good clinical decisions based on e- records of patients.  Bar-coded medication administration: System alerts the nurse to any mismatch of patient identity or of the name, dose, or route of administration of the medication. 6/16/2021 9
  • 13. CPOE helps in • Order entry into the pharmacy information system. • Online order verification by pharmacist • Computerized warnings for drug allergies. • Inappropriate doses. • Drug-drug interactions. • Computer-supported medication supply and distribution. • Automated label generation. • Computerized pharmacy billing. 6/16/2021 13
  • 14. Computerized Physician Order Entry (CPOE) 6/16/2021 14
  • 15. Role in Pharmaceutical Industry 1. Management of data: Enterprise Resource Planning (ERP):  An ERP system integrates all data and processes of an organization.  The purpose of ERP is to facilitate the flow of information between all business functions inside the boundaries of the organization and manage the connections to outside stakeholders. 6/16/2021 15
  • 16. ERP consists of various modules • Production and inventory management • Weighing and dispensing • E-batch records • E-packaging records • Financial accounting • Personnel management • Training and development 6/16/2021 16
  • 17. 2. Management of laboratory information: Laboratory Information Management System (LIMS) • It manages the information flow within the lab and can be the modus operandi of connecting the lab with the rest of the organization. • Automates lab processes to increase productivity, efficiency and quality in analysis. • More important is that, it takes care of 70% of laboratory guidelines, what we called as GLP 6/16/2021 17 Role in Pharmaceutical Industry
  • 18. It helps from: • Sample request to sample registration • Sample collection • Automatic calculations of tests methods • Specification maintenance • Assigning properties to those tests • Recording results, generating reports • Issuing COA’s (Certificate of Analysis) 6/16/2021 18
  • 19. 3. Customer Relationship Management (CRM) Sales Force Automation (SFA) Software • SFA are information systems used in CRM that helps to automate some sales and sales management functions. • It is a system that automatically records all the stages in a sales process. • It manages data, controls on-line movement of goods and manpower, including distribution network for pharmaceutical marketing 6/16/2021 19 Role in Pharmaceutical Industry
  • 20. It automates all the areas starting from • On-line records • Doctor visit reports • Tour plans and approvals, • Sales summaries & Booking sales orders • Expense details & stockiest inventory 6/16/2021 20
  • 21. 4. Management of manufacturing and packing records Electronic Batch Records (EBR) Software • It is a software for on-line management of batch manufacturing and packaging records. • It converts the bulky documentation work into very centralized automatic version. • EBR aggregates data from across various departments and summarizes it into one consolidated record for the lot produced. 6/16/2021 21 Role in Pharmaceutical Industry
  • 22. It performs following functions • Secured document management • Checks data integrity • Performs automatic calculations • Automatic audit trail • Other control measures to help ensure compliance with 21 Cost and Freight (CFR) Part 11 regulation. 6/16/2021 22
  • 23. 1. Drug Discovery  Drug Design: A) Target protein structure prediction B) Drug protein interaction study  Drug Screening A) Bioactivity predication B) Toxicity predication C) Physicochemical properties predication 2. Pharmaceutical product development A) Aid in deciding suitable exceptions B) Monitoring and modifying development process C) Ensuring in-process specification compliance 6/16/2021 23 Role in Research and Development
  • 24. 3. Pharmaceutical manufacturing A) Automated manufacturing B) Correlating manufacturing errors to set parameters C) Personalized manufacturing 4. Quality Assurance and Quality Control A) Understanding critical process parameter B) Guide future production cycle C) Regulation of in-line quality D) Ensure QA with aid of Electronic Laboratory Notebook (ELN) and other techniques 6/16/2021 24 Role in Research and Development
  • 25. 5. Clinical trail design and monitoring A) Subject enrollment or selection B) Patient drop out C) Monitoring of trails 6. Pharmaceutical product management A) Market positioning B) Market prediction and analysis C) Product coasting 6/16/2021 25 Role in Research and Development
  • 26. Some of the software use in pharmaceuticals Research & Development • ChemDraw: With its origins as a chemical drawing tool, ChemDraw has evolved steadily to become the leading chemically-intelligent solution for multiple disciplines from specialty chemistry to pharmaceutical drug discovery. • AutoDock: It is designed to predict how small molecules, such as substrates or drug candidates, bind to a receptor of known 3D structure. • CDD Vault: It helps project team manage, analyze and present chemical structures and biological assay data. 6/16/2021 26
  • 27. • adWATCH: Helps pharmaceutical organizations manage and report adverse events that occur during clinical trials. • Virtual Labs: Initiative by Ministry of Education, Government of India with an aim to provide remote-access to Labs in various disciplines of Science and Engineering. 6/16/2021 27
  • 28. Summary To sum up… • High competition, less time to reach the market and a highly regulated environment have forced Indian pharma companies to adopt advanced and latest IT and automation solutions. • In the recent years, there has been a significant rise in the use of computer related systems in the pharma industry. 6/16/2021 28
  • 29. • Many industries have got most of their operations computerized. • Not just the big pharma companies, but even about 70% of the small and medium enterprises utilize automation in one form or the other. • Software systems are being increasingly accepted as an essential part of a modern and progressive pharma industry. 6/16/2021 29 Summary (Continue….)