This document is a report on Good Manufacturing Practices (GMP) prepared by Vishal H. Parikh for his M.Pharm QARA program. It was guided by Mr. Darshil Shah of the QA department at L.J. Institute of Pharmacy. The report defines GMP, discusses its history and principles, and covers key aspects of GMP including documentation, production processes, facilities, personnel, validation, equipment maintenance, and calibration. GMP regulations are designed to minimize risks in pharmaceutical production that cannot be eliminated through final testing alone.

1. GOOD MANUFACTURING
PRACTICE
GUIDED BY:
Mr. Darshil Shah
Asst. PROFESSOR
QA DEPARTMENT
L.J.INSTITUTE OF PHARMACY
VISH
PREPARED BY:
Vishal H. Parikh
ROLL NO : 06
M.PHARM QARA
SEMESTER - II
8 February 2014
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2. CONTENT
 INTERODUCTION
 DEFINITION
 HISTORY
 PRINCIPLE
 PROCESS OF GMP
 VALIDATION
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3. WHAT IS GMP?
 GMP regulations are promulgated and enforced by
the FDA and primarily housed within the Federal
Food, Drug, and Cosmetic Act
 GMPs are based on industry best practices that
continually evolve as science, technology, and
manufacturing techniques change
 Comprehensive system for ensuring products are
consistently produced and controlled according to
quality standards
 Designed to minimize risks involved in any
pharmaceutical production that cannot be eliminated
through testing of final product alone
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4. MAJOR RISKS IN
PHARMACEUTICAL PRODUCTION
 Contamination of products (microbial, particulate or other)
 Incorrect labels on containers
 Insufficient active ingredient
 Excess active ingredient
 Poor quality raw materials
 Poor formulation practices
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5. ANALYSIS OF SUBSTANDARD
MEDICINES
Correct Ingredient
7%
Incorrect Ingredient
16%
Incorrect Amount
17%
No Active Ingredient
60%
Source: (WHO)
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6. THE BREADTH OF GMP

Raw or starting materials

Finished products

Premises and environment

Equipment

Personnel
 Training
 Hygiene
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7. GMP PRINCIPLES
 Must be built into manufacturing process
 Prevents errors that cannot be eliminated through quality control of
finished product
 Ensures all units of a medicine are of the same (within specified
parameters) quality
 Poor medicines leads to loss of credibility for
manufacturers, health care workers and governments
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everyone:
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8. GMP: 1972
 Davenport disaster
 Intravenous fluids were contaminated & killed 6 people.
 Prompted GMP regulations
 Sulphathiazole tablets contaminated with
phenobarbital (1941 - 300 people died/injured)
 Thalidomide tragedy
1976 Medical Device Amendments
 1972 and 1973 -Pacemaker failures reported
 1975 - hearing-Dalkon Shield intrauterine device
caused thousands of injuries
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9. CGMPS DEFINED
Methods, facilities, or controls used in
the
production
of
drugs, devices, foods, and biological.
These manufacturing practices are
designed
to
ensure
the
safety, identity, strength, quality, and
purity of such products.
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10. GMPs Regulations Address
Documentation/Records
Process and production controls
Physical plant, laboratory, and facility
design
Personnel / Quality control oversight
GMPs Regulations also Address
Materials Management
Packaging & Labeling
Storage & Distribution
Laboratory Controls
Rejection and Reuse Materials
Proper validation of processes
Complaints & Recalls
Maintain and calibrate equipment
Agents, Brokers, Distributors,
Repackers, and Relabellers
Clinical trial requirements
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11. VISH
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12. TEN PRINCIPLES OF GMPS
Principle 1
• Writing detailed step-by-step procedures that provide a roadmap
for controlled and consistent performance.
Principle 2
• Carefully following written procedures to prevent
contamination, mixups and errors.
Principle 3
• Promptly and accurately documenting work for compliance and
traceability.
Principle 4
• Proving that systems do what they are designed to do by
validation work.
Principle 5
• Integrating productivity, product quality, and employee safety into
the design and construction of facilities and equipment.
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13. TEN PRINCIPLES OF GMPS
CONT…
Principle 6
• Properly maintain facilities and equipment.
Principle 7
• Clearly defining, developing and demonstrating job
competence.
Principle 8
• Protecting products against contamination by making
cleanliness a daily habit.
Principle 9
• Building quality into products by systematically controlling
our components and product related processes such as
manufacturing, packaging and labelling, testing, distribution
and marketing.
Principle 10
• Conducting planned and periodic audits for compliance and
performance.
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14. GMP – DOCUMENTATION &
RECORDS
 Maintain laboratory and production records notebooks, electronic files, etc.
 Track records through research and production
 Batch Package Records (BPR)
 Equipment usage, calibrating, cleaning, maintenance
 Laboratory control records
 Distribution records
 Records maintained
 Electronic signatures on documents are
acceptable, provided they are authenticated and secure
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15. GMP – PROCESS AND
PRODUCTION CONTROL
 Standards for weighing, measuring, storing,
controlled
 Time limits (if applicable and necessary)
 In-process assurance, sampling and controls
 Blending, mixing, diluting substances
 Contamination controls
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16. GMP – PHYSICAL
PLANT, LABORATORY FACILITIES
DESIGN
 Design and Construction
 Single use versus multiuse facility, proper separation
 Utilities
 Air quality - Filtered, recirculation, one-pass
 Natural Gas
 Dust, humidity, temperature
 Water
 Municipal versus well versus sterilized
 Lighting (placed to facilitate cleaning in all areas)
 Sewage and Refuse
 Sanitation and Maintenance
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17. GMP – PERSONNEL / QUALITY
CONTROL OVERSIGHT
 Quality should be the responsibility of all persons
involved in manufacturing
 Each manufacturer should establish, document, and
implement an effective system for managing quality
that involves the active participation of management
and appropriate manufacturing personnel
 All quality related activities should be recorded at
the time they are performed
 There should be a quality unit(s) which is
independent of production, and which fulfills both
quality assurance (QA) and quality control (QC)
responsibilities
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18. GMP – PERSONNEL / QUALITY
CONTROL OVERSIGHT CONT..
 In order to verify compliance with the principles of
GMP, regular internal audits should be performed in
accordance with an approved schedule
Audit findings and corrective actions should be
documented
 Here should be an adequate number of personnel
qualified by appropriate education, training and/or
experience to perform and supervise the processes
Responsibilities of all personnel engaged in the
manufacture should be documented in writing
Training should be regularly conducted by qualified
individuals
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19. GMP - VALIDATION
 Policies, intentions, approaches, systems, cleaning procedures, and
all other protocols should be validated/documented
 Critical parameters, limitations, ranges and standards should be
established
 A written validation protocol should be established that specifies
how validation of a particular process will be conducted
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20. GMP – VALIDATION CONT…
 Appropriate qualification of equipment and ancillary
systems should be completed
 Design qualification, Installation qualification, Operational
qualification, Performance qualification
 Validate processes to ensure protocols are being
followed
 Number of process validations depends on complexity of
the tasks
 Cleaning and maintenance validation should be
obtained
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21. GMP – EQUIPMENT
MAINTENANCE & CALIBRATION
 Equipment used should be of appropriate design
and adequate size, and suitably located for its
intended use, cleaning, sanitization (where
appropriate), and maintenance
Production equipment should only be used
within its qualified operating range
Closed or contained equipment should be
used whenever appropriate
Any substances necessary for the operation of
equipment, such as lubricants, heating fluids
or coolants, should not contact tested items so
as to alter their quality
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22. GMP – EQUIPMENT
MAINTENANCE & CALIBRATION
CONT…
 Schedules and procedures (including assignment
of responsibility) should be established for the
preventative maintenance of equipment
 Written procedures should be established for
cleaning of equipment and its subsequent release
for use in the manufacture
 Control, weighing, measuring, monitoring and test
equipment that is critical for assuring quality
should be calibrated according to written
procedures and an established schedule
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