GOOD MANUFACTURING
PRACTICE

GUIDED BY:
Mr. Darshil Shah
Asst. PROFESSOR
QA DEPARTMENT
L.J.INSTITUTE OF PHARMACY
VISH

PRE...
CONTENT
 INTERODUCTION
 DEFINITION
 HISTORY
 PRINCIPLE
 PROCESS OF GMP
 VALIDATION

VISH

8 February 2014

2
WHAT IS GMP?
 GMP regulations are promulgated and enforced by
the FDA and primarily housed within the Federal
Food, Drug,...
MAJOR RISKS IN
PHARMACEUTICAL PRODUCTION
 Contamination of products (microbial, particulate or other)
 Incorrect labels ...
ANALYSIS OF SUBSTANDARD
MEDICINES
Correct Ingredient
7%

Incorrect Ingredient
16%

Incorrect Amount
17%

No Active Ingredi...
THE BREADTH OF GMP


Raw or starting materials



Finished products



Premises and environment



Equipment



Perso...
GMP PRINCIPLES
 Must be built into manufacturing process
 Prevents errors that cannot be eliminated through quality cont...
GMP: 1972
 Davenport disaster
 Intravenous fluids were contaminated & killed 6 people.
 Prompted GMP regulations

 Sul...
CGMPS DEFINED

Methods, facilities, or controls used in
the
production
of
drugs, devices, foods, and biological.
These ma...
GMPs Regulations Address
Documentation/Records
Process and production controls
Physical plant, laboratory, and facility
de...
VISH

8 February 2014

11
TEN PRINCIPLES OF GMPS
Principle 1
• Writing detailed step-by-step procedures that provide a roadmap
for controlled and co...
TEN PRINCIPLES OF GMPS

CONT…

Principle 6
• Properly maintain facilities and equipment.
Principle 7
• Clearly defining, d...
GMP – DOCUMENTATION &
RECORDS
 Maintain laboratory and production records notebooks, electronic files, etc.
 Track recor...
GMP – PROCESS AND
PRODUCTION CONTROL
 Standards for weighing, measuring, storing,
controlled
 Time limits (if applicable...
GMP – PHYSICAL
PLANT, LABORATORY FACILITIES
DESIGN
 Design and Construction
 Single use versus multiuse facility, proper...
GMP – PERSONNEL / QUALITY
CONTROL OVERSIGHT
 Quality should be the responsibility of all persons
involved in manufacturin...
GMP – PERSONNEL / QUALITY
CONTROL OVERSIGHT CONT..
 In order to verify compliance with the principles of
GMP, regular int...
GMP - VALIDATION
 Policies, intentions, approaches, systems, cleaning procedures, and
all other protocols should be valid...
GMP – VALIDATION CONT…
 Appropriate qualification of equipment and ancillary
systems should be completed
 Design qualifi...
GMP – EQUIPMENT
MAINTENANCE & CALIBRATION
 Equipment used should be of appropriate design
and adequate size, and suitably...
GMP – EQUIPMENT
MAINTENANCE & CALIBRATION
CONT…

 Schedules and procedures (including assignment
of responsibility) shoul...
VISH

8 February 2014

23
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By- VISHAL PARIKH

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Vish GMP Presentation

  1. 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 1
  2. 2. CONTENT  INTERODUCTION  DEFINITION  HISTORY  PRINCIPLE  PROCESS OF GMP  VALIDATION VISH 8 February 2014 2
  3. 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 VISH 8 February 2014 3
  4. 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 VISH 8 February 2014 4
  5. 5. ANALYSIS OF SUBSTANDARD MEDICINES Correct Ingredient 7% Incorrect Ingredient 16% Incorrect Amount 17% No Active Ingredient 60% Source: (WHO) VISH 8 February 2014 5
  6. 6. THE BREADTH OF GMP  Raw or starting materials  Finished products  Premises and environment  Equipment  Personnel  Training  Hygiene VISH 8 February 2014 6
  7. 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 VISH 8 February 2014 everyone: 7
  8. 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 VISH 8 February 2014 8
  9. 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. VISH 8 February 2014 9
  10. 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 VISH 8 February 2014 10
  11. 11. VISH 8 February 2014 11
  12. 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. VISH 8 February 2014 12
  13. 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. VISH 8 February 2014 13
  14. 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 VISH 8 February 2014 14
  15. 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 VISH 8 February 2014 15
  16. 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 VISH 8 February 2014 16
  17. 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 VISH 8 February 2014 17
  18. 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 VISH 8 February 2014 18
  19. 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 VISH 8 February 2014 19
  20. 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 VISH 8 February 2014 20
  21. 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 VISH 8 February 2014 21
  22. 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 VISH 8 February 2014 22
  23. 23. VISH 8 February 2014 23

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