BP606T PHARMACEUTICAL

QUALITY ASSURANCE

MR. SUANKIT HARANE

S M T . K I S H O R I T A I B H O YA R C O L L E G E O F P H A R M A C Y,
KAMPTEE
 COURSE CONTENT
UNIT – I
• Quality Assurance and Quality Management Concepts: Definition and concept of Quality control, Quality assurance and GMP
• Total Quality Management (TQM): Definition, elements, philosophies
• ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series
guidelines, ICH stability testing guidelines
• Quality by design (QbD): Definition, overview, elements of QbD program, tools
• ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration NABL accreditation : Principles and procedures

UNIT - II
• Organization and Personnel: Personnel responsibilities, training, hygiene and personal records.
• Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of
sterile areas, control of contamination.
• Equipment's and Raw Materials: Equipment selection, purchase specifications, maintenance, purchase specifications and
maintenance of stores for raw materials.

S M T . K I S H O R I T A I B H O YA R C O L L E G E O F P H A R M A C Y,
KAMPTEE
 UNIT – III
Quality Control: Quality control test for containers, rubber closures and secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities
Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports,
Disqualification of Testing Facilities
UNIT – IV
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal. Document
Maintenance in Pharmaceutical Industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality
Review and Quality documentation, Reports and documents, distribution records.
UNIT – V
Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation,
importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-
Visible spectrophotometer, General principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

S M T . K I S H O R I T A I B H O YA R C O L L E G E O F P H A R M A C Y,
KAMPTEE
 ISO 9000 & ISO14000
• The International Organization of Standardization (ISO) is a worldwide federation
consisting of member bodies from 91 countries, which promotes the development of
international manufacturing, trade and communication standards.
• The first ISO was published in the year of 1987, which were revised in 1994 as ISO
9000:1994.
• The next and latest revision of ISO standard was in 9000 and is therefore referred as
“ISO 9000: 2000 STANDARDS”
• The ISO 9000 family of standards is related to quality management systems and
designed to help organizations ensure that they meet the needs of customers and
other stakeholders while meeting statutory and regulatory requirements.
• ISO 9000 deals with the fundamentals of quality management systems, including the
eight management principles on which the family of standards is based. International
standards promote international trade by providing one consistent set of requirements
recognized around the world.
• ISO 9000 can help a company satisfy its customers, meet regulatory requirements
and achieve continual improvement. It provides the base level of a quality system,
not a complete guarantee of quality.
• ISO 14000 specifically addresses environmental aspects of quality management.
Three groups of instruments are dealt with: central to the system are the standards
related to environmental management systems. The second group deals with
evaluation and auditing. The third group entails product evaluation standards.
 Objectives of ISO
• The main objectives of ISO is to facilitate international trade by providing a single
intentionally accepted set of standards for everybody’s reference.
• ISO currently has three standards
1. ISO 9000: 2005
2. ISO 9001: 2015
3. ISO 9004: 2000
 Benefits of ISO
• It is only a base line model for quality assurance it raises the confidence of the third party
dealing with the registered unit.
• Provides senior management with an efficient management process.
• Suitable for both small and large organizations.
• Communicate a positive massage to staff and customers.
• Identifies and encourages more efficient and time saving processes.
• Better internal management
• Less wastage
• Increase in efficiency, productivity and profit
• Improved customer retention and acquisition
• Consistent outcomes, measured and monitored
• Globally recognized standard, marketing opportunities
• Marketing opportunities
 Elements of ISO 9000
1. Management Responsibility: Management sets the company quality policy and
implements it by providing resources, personal and training.
2. Quality system: A quality system comprises of quality manual and supporting
procedures is created and maintained.
3. Contract Reviewed: Contracts reflects the customers need and expectations.
Products and services provided must comply with those requirements.
4. Design Control: Engineering drawing and design changes are carefully
documented to ensure that changes gave been fully coordinated and approved
internally.
5. Document Control: The creation and modification of documents supporting the
quality system is strictly controlled by ISO 9001 procedures.
6. Purchasing: Purchasing procedures describe supplier requirements and the system
for ensuring compliance to these standards.
7. Handling of Purchaser: purchasing procedures describe supplier requirements and
the system for ensuring compliance of these standards
8. Product identification and traceability: method of tracking date and lot codes of
products and raw material from start to finish.
9. Process control: work instructions, quality plans and workmanship standards verify
that each job is being done correctly.
10. Inspection and testing: inspection and testing at receiving of raw material in
process and final inspections areas ensure quality. Test and inspections records are
preserved as a part of quality system.
11. Inspection measuring and test equipment: instruments and measuring tools are
calibrated regularly and records maintains.
12. Inspection and test status: inspected material may be used or process further
13. Control of nonconforming product: materials or products that fails to meet
specifications are rejected and separated from normal production
14. Corrective action: the corrective action system focuses on identifying root cause of
quality concerns and any corrective action required.
15. Handling, storage, packaging and delivery: procedures outline practices that
protect products from damage during manufacturing and shipping.
16. Quality records: quality record provide an audit trail for internal and external
auditors.
17. Internal quality audits: specially trained team verify that the quality system is
working by evaluating the same 20 elements required by the external auditors, on an
ongoing basis.
18. Training: Training records are maintained for every employee showing their level
of expertise.
19. Servicing: servicing is specified in the contract, procedures are established to verify
that servicing meet the indicated requirements.
20. Statistical techniques: control charts, graphs and other methods of analysis
determine how well a process is working and facilitate continuous improvement.
 Steps for ISO Certifications
Pre-Requisite to ISO certification process:
 Choosing the type of ISO certification
Various types of ISO certification available such as
1. ISO 9001: 2008 - Quality Management
2. ISO 14001 - Environmental Management
3. ISO 27001 - Information Security Management
4. ISO 22008 - Food safety management and so on
 Choosing an ISO certification body
It is very important to choose recognized and credible certification body
When choosing the ISO registrar, should follow follwing points
1. Evaluate several ISO certification providers
2. Check if they are following the CASCO standards (CASCO is ISO committee)
3. Check weather it is accredited or not
 Steps for ISO certification in India
1. Create an application/contract:
• The applicant and registrar should agree on a contract
• This contract usually defines rights and obligations of both parties and includes
liability issues, confidentiality and access rights.
2. Quality Document Review:
• The ISO auditor will view all the quality manuals and documents related to
various policies and procedures being followed in the organizations
• ISO auditor to identify the possible gaps against the requirements stipulated in
the ISO standards.
3. Make an Action Plan:
• After ISO auditor communicate the existing gaps in the organization, the
organization should prepare and action plan to eliminate these gaps.
4. Initial Certification Audit:
The initial certification audit is divided in to the two categories
• Stage 1
• Stage 2
Stage 1:
• The ISO auditor will audit the changes made by the organization.
• Then they will try to identify the possible non-conformities in the systems and
procedures to the desired quality management system.
Stage 2:
• After all the required changes are done in the organization, the ISO auditor does
the final auditing.
• The auditor will check weather all the non conformities have been eliminated or
not as per ISO quality standard if the ISO auditor is satisfied, they will prepare
the final ISO audit report and forward it to registrar.
4. Completing the ISO Certification:
After all non conformities are addressed and all the finding are put in the ISO audit
report, the registrar will grant you the ISO certification.
5. Surveillance Audits:
• Surveillance audits is basically conducted to ensure that ISO quality standards are
being maintained by the organizations
• It is conducted from time to time
 ISO 14000
ISO 14000 is a family of standards related to environmental management that exists to
help organizations to;
• Minimize how their operations (processes etc.) negatively affect the environment
(i.e. cause adverse changes to air, water or land).
• Comply with applicable law, regulations and other environmentally oriented
requirements.
• Continually improve in the above.
The ISO 14000 series of standard was introduced in the year 1996 by the ISO and most
recently revised in 2015.
• The ISO 14000 family of standards is developed by ISO technical committee
ISO/TC207 and its various subcommittees.
 ISO 14000: Standards and practices can be applied to any organization regardless of
size or industry.
 ISO 14001: 2015: Environmental Management system- requirement with guidance
for use
 ISO 14004: 2016: Environmental Management system- general guidelines on
implementations
 ISO 14005: Environmental Management system- Guidelines for flexible approach to
phase implementation.
 ISO 14006: 2011: Environmental Management system- Guidelines for incorporating
eco-design.
 ISO 14015: 2001: Environmental Management- Environment assessment of sites
and organizations (EASO)
 ISO 14020:2000 to 14025:2000: Environmental label and declaration- General
principal.
 ISO/NP 14030: Green Bonds- Environmental performance of nominated projects
and assets; discusses post production environmental assessment.
 ISO 14031: 2013: Environmental Management- Environmental performance
evaluation - general guidelines
 ISO 14040:2006 to 14049:2006: Environmental Management – Life cycle
assessment discuses pre-productive planning and environment goal setting
 ISO 14050: 2009: Environmental Management- Vocabulary, terms and definition.
 ISO/TR 14062: Environmental Management- integrating environmental aspects into
product design and development
 ISO 14063: 2006: Environmental Management- Environmental communication-
Guidelines and examples
 ISO 14064: 2006: Green House gases; measuring quantifying and reducing green
house gas emission
 ISO 14090: 2019: Adaptation to climate change – principles, requirements and
guidelines
 Benefits of ISO 14000
• It is a sign of commitment to the environment which can be used as marketing
tool for companies.
• It also helps companies to meet certain environmental regulations.
• To sell product to companies that use ISO 14000 certified suppliers
• Companies and customers may also pay more for products that are considered
environmental friendly
• Satisfies investors criterion
• Improve industry-government relations.
 Elements of ISO 14000
• Environmental Policy: Develop a statement of organizations commitment to
environment. Use this planning as a framework for planning and action.
• Environmental Aspects: Identify environmental attributes of the product, activities
and services
• Legal and other requirements: Identify and ensure access to relevant laws and
regulations.
• Objectives and Targets: Establish environmental goals for organization in line with
the policy, environmental impacts, views of interested parties and other factors.
• Environmental Management Program: Plan actions to achieve objectives and
targets.
• Structure and responsibility: Establish roles and responsibilities and provide
resources.
• Training, awareness and competence: ensure that employe of the organization are
trained and capable of carrying out their environmental responsibilities.
• Communication: Establish process for internal and external communications on
environmental management issues.
• EMS Documentations: Maintain information on EMS and related documents.
• Document Control: Ensure effective management to procedures and other systems.
THANK YOU…