Introduction to pharma industry

Introduction to
Pharmaceutical Industry
By:
Girish A. Swami (M.Pharm, PGDIPR, PGDDRA)
Cell: +91-9881492626
E-Mail: pr.girish@gmail.com

Outline
Describe the Functions and Responsibilities
performed by various departments within
pharmaceutical industry.
(If any difference found that will depend on focus, size, history, risk
tolerance, available resources and expertise in pharmaceutical
companies)

Pharma Industry
Production / Mfg.
House
Clinical Research
Organization
(CRO)

Pharma
Production
House
Production
Quality
Control
Quality
Assurance
Pharma
Engineering
Regulatory
Affairs

Three key personnel are named on a
pharmaceutical manufacturing site’s
Manufacturing Licence.
1. Head of Production
2. Head of Quality Control
3. Qualified Person (s) – (QP)

Production
Formulation
(Manufacturing)
Screening Packaging

Head of Production
• Products produced and stored according to appropriate documentation.
• Approval of production instructions and their strict implementation.
• Ensure production records are evaluated prior to sending to QC.
• Maintenance of department, premises and equipment.
• Validations performed.
• Initial and on-going training.

Quality Control
Chemical QC Microbiological QC Packaging QC
• API Testing QC
• FP Testing QC
• Instrument QC
• Microbial Testing QC
• E.M QC
• Pkg.Material Testing
• Art work Check
• Pack Insert Check

Head of Quality Control
• Approve or reject materials
(All components, Drug product containers, Closures, In-process
materials, Packaging material, Labelling and Drug Products.)
• Evaluate batch records.
• Ensure all testing performed.
• Approve specifications, etc.
• Ensure that if errors have occurred, that they have been fully
investigated
• Approve and monitor contract analysis.
• Maintain department, premises and equipment.
• Validations performed.
• Initial and on-going training.

Shared duties of
Heads of Production and QC
• Authorisation of written procedures and other documents.
• Monitoring and control of the manufacturing environment.
• Plant hygiene.
• Process validation.
• Training.
• Approval and monitoring of suppliers.
• Approval and monitoring of contract manufacture.
• Designation and monitoring of storage conditions.
• Retention of records.
• Monitoring of compliance to GMP.
• Inspection, investigation and taking samples.

The Qualified Person [QP]
(EU GMP)
• Products manufactured within EU – a QP must ensure that each batch
was produced and tested according to GMP and Licensed conditions
• Products manufactured outside the EU – a QP must ensure that each
imported batch has undergone, in the importing country re-testing and
evaluation
• A QP must sign a register to state that the above has been performed
satisfactorily before product is released (QP certification)
• Product Quality Review performed in a timely manner and accurate
(EU GMP 1.5)
• QP have authority to certify a batch for release.

Quality Assurance
System QA
• Vendor Audit
• Internal Audit
• Change Control
• CAPA
• Complaint handling
• Training
Process QA
• IPQA
• Risk Assessment
• Deviation
• OOS / OOT
• Process Validation
• Equipment Validation
• Software Validation

Role of QA
The role of QA is not defined in GMP and as per
EU roles already assigned in GMP to the Head
of QC and the QP can be delegated to QA, with
additional roles added as well.

Role of QA
• Control of Licences
• Liaison with Research & Development/ New Product Introduction
• Batch Review
• Batch Release
• Management of the Document Management system
• Management of the Internal Audit system
• Management of the GMP Training System
• Customer feedback and satisfaction
• Management of deviations, incidents and investigations
• Management of the Validation system
• Vendor assurance and supplier auditing

Role of QA
• Control of sub-contractors
• Performance monitoring and review
• Management Review
• Management of the Continual Improvement system
• Gathering and Trending of quality related data
• Data storage
• Management of the Product Quality review process
• Management of the Risk Management process
• Management of the Corrective Action system
• Management of the Preventative Action system

Pharmaceutical
Engineering
Qualification team
• FAT / SAT
• IQ / OQ / PQ / DQ
Maintenance Team
• Preventive Maintenance
• Calibration
• Breakdown Maintenance

Role of Pharmaceutical
Engineering
There is no formal need for an
Engineering Manager or Department in
GMP.

Role of the Engineering
• In the manufacture of medicines the equipment used and the
environment it is located in has a massive impact on product quality.
• The role of the Engineering Manager is therefore critical.
• Some of the roles already assigned in GMP to the Head of
Production can be delegated to Head of Engineering

Role of Head of Engineering
• Maintenance of premises and equipment.
• Design of facilities.
• Validation and qualification of equipment and facilities.
• Management of the calibration programme.
• Management of the Planned Preventative Maintenance
programme.
• Control and operation of site services (including water, steam
and HVAC systems).
• Control of engineering spares/ equipment spares.

Role of Head of Engineering
• Control of engineering contactors.
• Approval of engineering related procedures, documents and
drawings.
• Control and storage of engineering records.
• Control of equipment manuals.
• Pest control.
• Site security and access.
• Project Management.

Quality Management System
Pharmaceutical Quality Management Systems
(PQMS)
FDA
“Guidance for Quality Systems”
ICH Q10
“Guidance on Pharmaceutical Quality Systems”.

ICH Q10 model
ICH Q10 describes one comprehensive model
for an effective pharmaceutical quality system, It
can be implemented throughout the different
stages of a product lifecycle
• International Organization for Standardization (ISO) quality
concepts
• Good manufacturing practice (GMP) regulations
• ICH “Q8 Pharmaceutical Development”
• ICH “Q9 Quality Risk Management

QMS enhance the Quality and Availability of
medicines
It always facilitate Innovation and Continual
improvement and strengthen the link between
Pharmaceutical development and Manufacturing
activities.

Product Lifecycle Technical Activities
Pharmaceutical Development
– Drug substance development
– Formulation development (including container/closure system)
– Manufacture of investigational products
– Delivery system development (where relevant)
– Manufacturing process development and scale-up
– Analytical method development
Technology Transfer
– New product transfers during development through manufacturing
– Transfers within or between manufacturing and testing sites for marketed products
Commercial Manufacturing
– Acquisition and control of materials
– Provision of facilities, utilities, and equipment
– Production (including packaging and labeling)
– Quality control and assurance
– Release
– Storage
– Distribution
Product Discontinuation
– Retention of documentation
– Sample retention
– Continued product assessment and reporting

ICH Q10 Objectives
• Achieve Product Realization :
To establish, implement, and maintain a system that allows the delivery of
products with the quality attributes (e.g RA compliance & Reg.authority for
approval of regulatory filings)
• Establish and Maintain a State of Control:
To develop and use effective monitoring and control systems for process performance
and product quality (e.g Quality risk management)
• Facilitate Continual Improvement :
To identify and implement appropriate product quality improvements, process
improvements, variability reduction, innovations, and pharmaceutical quality system
enhancements (e.g Quality risk management)

Quality Risk Management
(ICH Q9)
Quality Risk Management is integral to an
effective pharmaceutical quality system.
It can provide a Proactive Approach to
– Identifying
– Scientifically Evaluating &
– Controlling Potential Risks to quality.

MANAGEMENT RESPONSIBILITY
• Management Commitment :
– Senior management - Ensure an effective quality objectives
• Quality Policy :
– Quality policy that describes the overall intentions and direction of the company related to
quality
– An expectation to comply with applicable regulatory requirements, continual improvement
– Policy should be reviewed periodically for continuing effectiveness
• Quality Planning :
– Quality objectives should align with the company’s strategies and be consistent with the
quality policy
– Management should provide the appropriate resources and training
• Resource Management :
• Internal Communication :
• Management Review :

Corrective And Preventive Action
(CAPA)
In general, CAPA experts recommend that root cause
investigations follow a four-step process:
• Identify the problem.
• Evaluate its magnitude, which includes assessing risk.
• Investigate and assign responsibility.
• Analyze and document the root cause of the problem.

Quality Assurance
All of the Quality Assurance’s audits are based on the
Pharmaceutical Law
Good Manufacturing Practice (GMP)
&
Good Laboratory Practice (GLP) Guidelines.
Good Quality Assurance System leads to a constant
increase of reliability and ensures compliance with
the currant regulatory requirements.

Regulatory Affairs
Regulated Market
(US, EU, MCC etc.)
Semi-Regulated Market /
Rest of World (RoW)
Market
• DMF
• CTD / eCTD
• NDA / ANDA
• DMF (Open Part / Close Part)
• Registration Dossier
• Tech. Pack
Pharma Product
Biological / Biotech
Product

Regulatory Affairs Department
Responsible for managing the interface between
the Sponsor and Regulatory Agencies (eg, FDA)
so that the information gained through the R&D
process meets the criteria for product
registration.

Functions in Regulatory Affairs
• Submission to Regulatory Authorities
• Participates in supporting and promoting electronic submissions and
electronic archives.
• Ensures that regulatory documents comply with the relevant guidelines.
• Identifies and records issues that require resolution prior to finalization
and liaises with responsible author to resolve issues.
• Assists authors in the completion and compilation of regulatory
documents to ensure all components are provided and presented in the
correct format.
• May provide training to functional group contributors on regulatory
document content and format.

Clinical
Research
Organization
Clinical
Operation
Pharmaco-
vigilance
Biostatistics
(Data
Management)
Medical
Affairs
Regulatory
Affairs
QA / QC
Clinical trail
Study
• Safety Expert
• Medical Monitor
• Data Analysis
• ADR Report
• Validation
• SAS program
• Lead data
management
Medical
Advisors
• Testing
• Facility audit
• Training
• GCP
Compliance
Document
submission

Major Components of the Clinical
Department
Statistician
Outcomes
Research
Clinician
Data
Services
Medical
Writer
Clinical
Research
Associate

Functions in Clinical Operations
– Project Management.
– Managing and coordination of study conduct
– Monitoring and tracking of project milestones to ensure that the
project runs within timelines.
– Participation as appropriate to CORE TEAMS to expedite the
feasibility and conduct of global trials
– Ensuring that the regulatory and EC’s submission are of
acceptable quality
– Support Investigator as and when required (e.g. Finalisation of
Investigator agreements and contracts; Finalisation of Protocols)

Functions in Pharmacovigilance
• Collect, follow-up, transmit all local adverse events (AEs), and pregnancy
cases, to Global Pharmacovigilance.
• Process cases in accordance with Global and Local Pharmacovigilance
procedures.
• Answer queries and requests from Global Pharmacovigilance.
• Answer ADR and ADR case processing questions from local Regulatory
Authorities and Health Care Professionals.
• Submit the reportable ADRs, (local & foreign) to the local Regulatory
Authorities according to the national regulations.
• Developing and maintaining the local Pharmacovigilance SOPs and Work
Practice Documents.
• Provide input into labeling changes to the Regulatory Affairs Department.
• To identify all local safety observational studies (Post-Authorization Safety
Studies), in conjunction with Regulatory Affairs.

Global Regulatory Guidelines
• ISO Guidelines (International Organization for Standardization)
• WHO Guidelines (World Health Organization)
• US-FDA Guidelines (United State Food & Drug Administration)
• ICH Guidelines (International conference on Harmonization)
• PIC/S Guidelines (Pharm. Inspection Convention & Pharm. Inspection
Co-operation Scheme)
• IPEQ Guidelines (International Pharmaceutical Excipients Council)

Global Regulatory Agencies
• UK - MHRA (Medicines & Healthcare Products Reg. Agency)
• South Africa - MCC (Medicine Control Conceal)
• Australia - TGA (Therapeutic Goods Administration)
• India - Drug & Cosmetic Act / Schedule M
• EU – EDQM (European Directorate for the Quality of Medicines &
HealthCare)
• Newzeland - MEDSAFE
• Gulf - GCC
• Japan - PDMA (Pharmaceutical & Medical devices Agency)

WHAT NEXT
Build your knowledge and experience level to
match the desired attributes.
• Attend Seminars or Courses in Regulatory,
QA/QC, GMP, Clinical trial design, Statistics etc.
• Acquire Specialized disease knowledge
• Acquire Specialized formulation knowledge
Publish (something - - - anything!)

What to do
[Knowledge, Skills and Abilities]
• Industry Knowledge/ Experience: Knowledge of applicable FDA regulatory
standards and requirements.
• Communication Skills: Advanced level of written and verbal communication
skills with the ability to read, analyze and interpret general business
periodicals, professional journals, technical procedures or governmental
regulations. Ability to write reports, business correspondence and
procedure manuals. Ability to effectively present information to plant
employees and the general public and lead in a team environment.
• Reasoning Ability: Ability to solve practical problems and deal with a
variety of concrete variables in situations where only limited standardization
exists. Ability to interpret a variety of instructions furnished in written, oral,
diagram or schedule form.
• Leadership: Effectively manage competing priorities, adaptable to
change, demonstrated ability to accept additional responsibilities and manage
tasks through teamwork.

Thank You….!
By:
Girish A. Swami
(M.Pharm, PGDIPR, PGDDRA)

Introduction to pharma industry

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