ICH Q7 - GOOD MANUFACTURING PRACTICE.pdf

this slides gives you a overview of Good Manufacturing Practice

1. ICH GOOD MANUFACTURING
PRACTICE
JECINTHO MERCY J
MSC CREM II

2. Understanding ICH GMP:
Ensuring Pharmaceutical
Quality and Patient Safety
The International Council for Harmonisation Good Manufacturing
Practice guidelines represent the gold standard for
pharmaceutical quality worldwide. These comprehensive
frameworks ensure that every medicine reaching patients meets
the highest standards of safety, efficacy, and consistency,
regardless of where it's manufactured or consumed.

3. What is ICH and Why Does GMP Matter?
ICH: International Council for
Harmonisation
The International Council for
Harmonisation of Technical
Requirements for
Pharmaceuticals for Human Use
brings together regulatory
authorities and pharmaceutical
industry representatives from
Europe, Japan, and the United
States. Established to create
unified global standards, ICH
eliminates regulatory duplication
and ensures consistent quality
worldwide.
Harmonizing Global Standards
ICH's primary mission is to
harmonize pharmaceutical
standards across different
regions, reducing regulatory
barriers while maintaining the
highest safety standards. This
harmonization accelerates the
development and availability of
safe, effective medicines for
patients globally, ensuring
consistent quality regardless of
manufacturing location.
GMP: The Quality Foundation
Good Manufacturing Practice
represents a comprehensive
system of controls ensuring
products are consistently
produced and controlled
according to established quality
standards. GMP covers every
aspect of production, from raw
materials and facilities to training
and hygiene, creating a robust
framework for pharmaceutical
manufacturing excellence.

4. ICH Quality Guidelines: The Foundation of GMP
The ICH quality guidelines form an integrated framework that addresses every aspect of pharmaceutical
development and manufacturing. These interconnected standards create a comprehensive quality system that
ensures medicines are developed scientifically and manufactured consistently.
1
ICH Q7: GMP for APIs
Establishes Good Manufacturing Practice guidelines specifically for Active Pharmaceutical Ingredients,
covering production, quality control, and quality assurance requirements for API manufacturing facilities
worldwide.
2
ICH Q8: Pharmaceutical Development
Introduces Quality by Design principles, emphasizing systematic development approaches that identify
and control critical quality attributes throughout the pharmaceutical development process.
3
ICH Q9: Quality Risk Management
Provides a systematic approach to quality risk management, helping manufacturers identify, assess,
control, and review risks to product quality throughout the product lifecycle.
4
ICH Q10: Pharmaceutical Quality System
Describes a comprehensive pharmaceutical quality system based on International Standards
Organization quality concepts and applicable Good Manufacturing Practice regulations.

5. ICH Q7: GMP for Active Pharmaceutical Ingredients
ICH Q7 provides the definitive framework for manufacturing Active
Pharmaceutical Ingredients with consistent quality and safety. This
comprehensive guideline ensures that APIs, the core components
of pharmaceutical products, are produced under controlled
conditions that guarantee their identity, strength, purity, and
quality.
Core Elements of API Manufacturing
Quality management systems with clear organizational
structure and responsibilities
Personnel qualifications, training, and hygiene requirements
Comprehensive documentation and record-keeping systems
Process validation and continuous monitoring protocols
Contamination control and cross-contamination prevention
Critical process parameter monitoring and control
The guideline emphasizes a risk-based approach to quality
assurance, ensuring that manufacturers focus resources on the
most critical aspects of API production while maintaining overall
system integrity.

6. ICH Q8: Pharmaceutical Development
ICH Q8 introduces the transformative concept of Quality by Design (QbD), shifting the pharmaceutical industry's
focus from "testing quality in" to "building quality in" from the earliest development stages. This systematic,
science-based approach ensures product quality and process robustness.
Quality by Design (QbD)
A systematic development approach that
begins with predefined objectives,
emphasizing product and process
understanding based on sound science
and quality risk management.
Enhanced Understanding
Focuses on identifying and controlling
Critical Quality Attributes (CQAs), Critical
Material Attributes (CMAs), and Critical
Process Parameters (CPPs) to ensure
consistent product quality.
Benefits & Innovation
QbD leads to a more robust
manufacturing process, reduced batch
failures, and facilitates continuous
improvement and innovation within the
product lifecycle.

7. ICH Q9: Quality Risk Management
ICH Q9 provides a systematic approach to quality risk management, integrating formal processes into
pharmaceutical development and manufacturing. This guideline empowers companies to proactively identify,
assess, control, communicate, and review risks to product quality throughout its lifecycle.
01
Risk Assessment
Identify potential hazards, analyze their likelihood and
severity, and evaluate their significance to product
quality.
02
Risk Control
Implement measures to reduce or accept risks to an
acceptable level, ensuring patient safety and product
integrity.
03
Risk Communication
Share information about risks and risk management
activities among stakeholders to foster transparency
and informed decision-making.
04
Risk Review
Continuously monitor and review risks throughout the
product lifecycle to ensure the effectiveness of control
measures and adapt to new information.
By applying ICH Q9, manufacturers can make sound, science-based decisions that enhance product quality and
minimize potential patient harm.

8. ICH Q10: Pharmaceutical Quality System
ICH Q10 integrates Good Manufacturing Practice (GMP) principles with modern quality management, establishing a
comprehensive Pharmaceutical Quality System (PQS). This guideline promotes a lifecycle approach to quality,
ensuring product quality throughout development, manufacturing, and distribution, ultimately safeguarding
patient health.
Product Realization
Ensuring quality is consistently built
into the product from early
development through commercial
manufacturing and discontinuation.
Continual Improvement
Driving ongoing enhancements to
the PQS through regular
performance monitoring, review,
and corrective actions.
Management Review
Involving senior management in
periodic evaluations of the PQS to
ensure its effectiveness and
strategic alignment.
Knowledge Management
Systematically acquiring,
maintaining, and utilizing product
and process knowledge throughout
the product lifecycle.

9. The 5 Pillars of GMP Compliance
GMP compliance rests on five fundamental pillars that work together to ensure pharmaceutical quality. Each pillar
is essential, and weakness in any area can compromise the entire quality system.
People
Qualified, trained personnel form the
foundation of GMP. Every individual must
understand their role in quality assurance,
from senior management to production
operators. Continuous training ensures
competency and awareness of quality
responsibilities.
Processes
Validated, controlled manufacturing
processes ensure consistent product
quality. Every step must be documented,
monitored, and controlled. Process
validation demonstrates that procedures
consistently produce products meeting
predetermined specifications.
Premises & Equipment
Facilities and equipment must be
designed, maintained, and operated to
prevent contamination, mix-ups, and
quality failures. Proper design, preventive
maintenance, and calibration are critical
for reliable operations.
Documentation
Accurate, complete documentation
ensures traceability and accountability
throughout manufacturing. Records
demonstrate compliance, enable
investigations, and support continuous
improvement efforts. Documentation must
be contemporaneous and accurate.
Quality Management
Robust quality management systems drive
continuous improvement and ensure
regulatory compliance. This includes
quality planning, quality control, quality
assurance, and quality improvement
activities integrated throughout operations.

10. 14 Core Principles of GMP 3
PHARMACEUTICAL
P 3 People (Personnel)
People are the backbone of GMP. All personnel involved in
manufacturing must be adequately trained, qualified, and
experienced for their assigned roles.
Training should cover not only technical skills but also GMP
awareness, safety, and hygiene practices. Personnel must
understand the impact of their work on product quality and
patient safety.
Health monitoring, use of protective clothing, and adherence to
personal hygiene standards are essential.
Clear roles and responsibilities should be defined to avoid
mistakes and overlap in critical operations.

11. H 3 Hygiene
Maintaining high standards of hygiene is vital to
prevent contamination and cross-contamination.
Both premises and equipment must be kept clean,
sanitized, and disinfected at regular intervals.
Cleaning schedules and procedures should be
documented and validated.
Employees must follow strict handwashing,
gowning, and entry/exit procedures in production
and cleanroom areas.
Pest control measures, waste disposal systems,
and regular monitoring of cleaning effectiveness
form an integral part of GMP hygiene.

12. A 3 Environment (Ambient Conditions)
The manufacturing environment plays a direct role in ensuring
the quality and safety of medicines.
Parameters such as temperature, humidity, and air quality
must be controlled and continuously monitored.
Cleanrooms and controlled environments require air filtration
systems (like HEPA filters) and pressure differentials to prevent
entry of contaminants.
The design and layout of premises should allow smooth
material and personnel flow, reducing risks of mix-ups and
contamination.
Monitoring and maintaining the right environmental conditions
ensures product integrity throughout production.

13. R 3 Raw Materials
The quality of the final product largely depends on the raw
materials used.
All raw materials must be sourced only from approved,
qualified suppliers who meet regulatory requirements.
They must be stored in appropriate conditions (temperature,
humidity, segregation) to maintain their stability and prevent
degradation.
Each batch of raw materials should undergo identity and
quality testing before use in production.
Proper labeling, traceability, and inventory management
systems help ensure that only approved materials enter the
production process.

14. M 3 Materials (Validation & Monitoring of Processes)
Processes and materials management must be validated and
monitored to ensure consistent results.
Process validation confirms that a manufacturing method
consistently produces a product meeting specifications.
Critical process steps should be closely monitored using in-
process controls. Materials, including excipients, packaging,
and labeling components, must be checked for compliance
with quality standards.
Any deviation in process or material handling should trigger
investigation and corrective action to maintain product
integrity.

15. A 3 Equipment (Apparatus)
All equipment used in manufacturing must be suitable for its
intended purpose. Equipment must undergo installation
qualification (IQ), operational qualification (OQ), and
performance qualification (PQ) before use.
Regular calibration, preventive maintenance, and cleaning are
required to prevent breakdowns, contamination, or inaccurate
results.
Equipment logbooks should be maintained to track usage,
cleaning, and repairs.
Equipment design should allow easy cleaning and minimize
the risk of cross-contamination.

16. C 3 Compliance (Documentation)
Documentation is a cornerstone of GMP,
summarized by the phrase <If it isn9t documented, it
didn9t happen.=
Every action, observation, and result must be
recorded accurately, legibly, and in real time.
Documentation includes Standard Operating
Procedures (SOPs), batch manufacturing records,
logbooks, and validation reports.
Good Documentation Practices (GDP) require that
records be signed, dated, and traceable to
individuals.
Proper documentation ensures transparency,
accountability, and the ability to trace back any
quality issue to its source.

17. E 3 Procedures (Processes)
Clearly defined and validated procedures ensure consistency
in operations.
For every critical activity4such as weighing, mixing, cleaning,
or packaging4there must be a written SOP that employees
follow.
Procedures should be reviewed periodically and updated when
changes occur in processes, technology, or regulations.
Process validation ensures reproducibility and compliance
with specifications.
Standardized procedures reduce variability and human error,
ensuring that every batch produced meets the same high-
quality standard.

18. U 3 Utilities
Utilities such as purified water, steam, compressed air, and
gases are essential in pharmaceutical manufacturing.
Since they come in direct or indirect contact with products,
their quality must be qualified, monitored, and controlled.
For example, water systems must be designed to prevent
microbial growth, and compressed air must be filtered to
remove oil, particulates, and moisture.
Utilities must meet pharmacopeial standards and undergo
regular testing. Any deviation in utility quality can compromise
product safety and efficacy.

19. T 3 Testing (Quality Control)
Testing is a critical principle of GMP, ensuring that products
meet predefined specifications before release.
Raw materials, in-process samples, and finished products
must undergo rigorous testing in a quality control laboratory.
Analytical methods used should be validated for accuracy,
precision, and reproducibility.
The QC department must operate independently from
production to avoid conflicts of interest.
Stability studies must also be conducted to establish product
shelf life.
Only products that pass QC testing should be released to the
market

20. I 3 Inspections (Self-Inspection)
Regular inspections and audits are required to verify GMP
compliance.
Self-inspections involve internal audits conducted by trained
staff to identify gaps, deviations, or potential risks.
Findings must be documented, and corrective and preventive
actions (CAPA) should be implemented promptly.
In addition to internal audits, external inspections by regulatory
authorities (like FDA, EMA, or WHO) ensure compliance with
national and international GMP standards.
Routine inspections encourage continuous improvement and
readiness for official audits.

21. C 3 Complaints & Recalls
A robust system for handling complaints and recalls protects
patient safety and maintains public trust.
Complaints should be documented, investigated, and
addressed with corrective actions.
Trend analysis of complaints can highlight recurring issues in
manufacturing or distribution.
In case of a defective or harmful batch, a recall procedure must
be activated immediately.
Recalls should be rapid, efficient, and traceable to prevent
affected products from reaching patients.
Every company must have a recall policy approved by
regulatory authorities

22. A 3 Storage & Dispatch
Finished products must be stored under controlled conditions
to maintain their quality until use.
Storage areas must be clean, secure, and designed to prevent
contamination or mix-ups.
Distribution should follow the FEFO (First Expiry, First Out)
principle to minimize wastage and ensure patients receive
products within shelf life.
Transportation must protect products from damage,
temperature extremes, and humidity.
Documentation of storage and dispatch records ensures
traceability and accountability.

23. L 3 Legal (Licenses)
All manufacturing and marketing activities must be carried out
under valid licenses issued by regulatory authorities.
Licenses certify that facilities, processes, and personnel
comply with GMP and legal requirements.
Any change in premises, processes, or products must be
reported to authorities for re-approval.
Companies must also comply with local, national, and
international regulations governing pharmaceutical
production.
Legal compliance protects both the company and the patient,
ensuring that only safe and effective products reach the
market.

24. Regulatory Bodies Enforcing
GMP Worldwide
Adherence to ICH GMP guidelines is enforced by various national
and international regulatory authorities. These bodies play a
crucial role in ensuring that pharmaceutical products are
consistently produced and controlled according to quality
standards, safeguarding public health globally.
FDA (USA)
The U.S. Food and Drug Administration oversees the manufacturing and
quality of drugs, medical devices, and biological products within the United
States.
EMA (Europe)
The European Medicines Agency is responsible for the scientific evaluation,
supervision, and safety monitoring of medicines in the European Union.
WHO (Global)
The World Health Organization develops international norms and
standards, including GMP guidelines, to ensure the quality and safety of
medical products worldwide.
Health Canada
Health Canada regulates health products and food in Canada, ensuring
compliance with GMP and other safety and efficacy standards.
These agencies conduct inspections, issue licenses, and enforce
compliance, acting as critical gatekeepers for safe and effective
medicines reaching patients.

25. GMP vs. cGMP: The Drive for Continuous
Improvement
1
Traditional GMP
Good Manufacturing Practice
established basic standards for
manufacturing quality, providing
fundamental requirements for
facilities, equipment, and
procedures. These standards
created the foundation for
pharmaceutical manufacturing
consistency and reliability.
2
Current GMP (cGMP)
Current Good Manufacturing
Practice emphasizes ongoing
updates and improvements,
requiring manufacturers to keep
systems and technologies current
with advancing science and
technology. The "current" aspect
ensures standards evolve with
industry capabilities.
3
Future-Ready Quality
cGMP creates a dynamic
framework that adapts to
emerging technologies, new
scientific understanding, and
evolving patient needs. This
approach ensures pharmaceutical
quality systems remain effective
and relevant in a rapidly changing
industry landscape.
The evolution from GMP to cGMP represents a fundamental shift from static compliance to dynamic quality
improvement. This approach recognizes that pharmaceutical manufacturing must continuously advance to meet
growing patient expectations and regulatory requirements while incorporating new technologies and scientific
developments.

26. Real-World Impact: Why ICH GMP Saves Lives
ICH GMP guidelines have a direct, measurable impact on patient safety and public health worldwide. These
standards prevent countless adverse events and ensure that patients receive consistently safe, effective
medicines regardless of where they live or where their medicines are manufactured.
99.9%
Product Quality Rate
GMP-compliant facilities achieve
exceptional quality performance,
with defect rates measured in parts
per million rather than percentages.
75%
Recall Prevention
Robust GMP systems prevent
approximately three-quarters of
potential quality failures before
products reach patients.
50+
Countries Aligned
Over 50 countries have adopted ICH
GMP principles, creating a global
network of quality assurance for
pharmaceutical products.
"GMP compliance prevents contamination, mix-ups, and product recalls while ensuring medicines are safe,
effective, and of consistently high quality. These standards protect patients worldwide by harmonizing
manufacturing requirements across borders, creating a unified approach to pharmaceutical quality that
transcends geographical boundaries."

27. Conclusion: ICH GMP as the Backbone of
Pharmaceutical Excellence
ICH GMP guidelines represent more than regulatory requirements4they embody a global commitment to
pharmaceutical excellence that puts patient safety at the center of every decision. These frameworks create the
foundation upon which the modern pharmaceutical industry builds trust, innovation, and sustainable success.
Global Quality Framework
ICH GMP guidelines create a
unified approach to
pharmaceutical quality that
transcends geographical
boundaries, enabling consistent
standards worldwide while
respecting regional regulatory
requirements and cultural
considerations.
Patient Safety Priority
Every aspect of GMP compliance
ultimately serves patient safety.
This non-negotiable commitment
to quality ensures that patients
worldwide receive medicines they
can trust, regardless of
manufacturing location or
distribution channel.
Cultural Excellence
True GMP compliance extends
beyond procedural adherence to
embrace quality as an
organizational culture. Leading
pharmaceutical companies view
GMP as an opportunity to
demonstrate excellence and drive
innovation rather than merely
meeting minimum requirements.

28. Quality is not an act, but a habit in
pharmaceutical excellence