Professional Documents
Culture Documents
CONTENTS
DEFINATION OF GMP PRINCIPLES OF GMP IMPORTANCE OF GMP INTERRELATIONSHIPS OF QA,QC,GMP IMPORTANT DOCUMENTS IN GMP ATTRIBUTES OF GOOD DOCUMENTS GENERAL PROVISIONS 1.BUILDING&FACILITIES 2.EQUIPMENTS
www.bpharmstuf.com
3.Production&process control 4.Packaging&labelling control 5.Handling&distribution 6.Labaratory control 7.Records&reports Conclusions References
www.bpharmstuf.com
What is GMP ?
GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use
"GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic
goods, helps ensure that the products manufactured will have the required quality.
www.bpharmstuf.com
What is cGMP ?
Usually see cGMP where c = current, to emphasize
www.bpharmstuf.com
Quality Definition:
Quality of a medicinal product is measured by its
fitness for purpose . Safety and efficacy are not separable from Quality but part of it
www.bpharmstuf.com
www.bpharmstuf.com
www.bpharmstuf.com
www.bpharmstuf.com
www.bpharmstuf.com
10
GMP Covers
ALL aspects of production; from the starting materials,
correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
www.bpharmstuf.com
11
GMP:
The Quality of a formulation or a bulk drug depends
GMP is the magic key that opens the door of the Quality. In matter of GMP, swim with the current and in matter of Quality stand like a rock!
www.bpharmstuf.com
12
www.bpharmstuf.com
13
Inter-relationship of QA,GMP&QC:
GMP
Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use
www.bpharmstuf.com
14
www.bpharmstuf.com
15
QC and QA:
QC is that part of GMP
QA is the sum total of which is concerned with sampling, organized arrangements made with the object of specifications, testing and ensuring that product with in the organization, documentation,and release will be of the Quality procedures which ensure required by their that the necessary and intended use. relevant tests are carried out
www.bpharmstuf.com
16
QC and QA:
Operational laboratory All those planned or
systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
www.bpharmstuf.com
17
QC and QA:
QC is lab based
QA is company based
www.bpharmstuf.com
18
GMP:
GMP in solid dosage forms
GMP in semisolid dosage forms GMP in Liquid orals
www.bpharmstuf.com
20
Beyond GMP:
Reduce pollution - Zero discharge Adaptation of environment friendly methods Consideration for better and healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end
www.bpharmstuf.com
21
Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation)
www.bpharmstuf.com 22
www.bpharmstuf.com
23
Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized
www.bpharmstuf.com 24
designed, maintained, and cleaned Standard Operating Procedures (SOPs) be written and approved An independent Quality unit (like Quality Control and/or Quality Assurance) Well trained personnel and management
www.bpharmstuf.com 25
www.bpharmstuf.com
26
General Provision:
1.
2.
Scope
Definitions
www.bpharmstuf.com
27
Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance.
www.bpharmstuf.com
28
Equipment:
1. 2. 3. 4. 5.
Equipment design, size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. Filters.
www.bpharmstuf.com
29
4.
5.
6.
7.
General requirements. Receipt & storage of untested components, drug product containers, and closures. Testing and approval or rejection of components, drug product containers, and closures. Use of approved components, drug product containers, and closures. Retesting of approved components, drug product containers, and closures. Rejected components, drug product containers, and closures. Drug product containers and closures.
www.bpharmstuf.com 30
Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-evident packaging requirements for overthe-counter (OTC) human drug products. Drug product inspection. Expiration dating.
www.bpharmstuf.com
32
Warehousing procedures.
Distribution procedures.
www.bpharmstuf.com
33
Laboratory Control:
1.
2. 3. 4. 5. 6. 7.
General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contamination.
www.bpharmstuf.com
34
6.
7. 8. 9.
General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records. Master production and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files.
www.bpharmstuf.com 35
www.bpharmstuf.com
36
CONCLUSIONS: For the time being, the approach is different but the principles are much the same: a complete and operative Quality System demonstrating that there is overall control.
www.bpharmstuf.com
37
References Notes ^ U.S. Food and Drug Administration (2007-06-22). "FDA Issues Dietary Supplements Final Rule". Press release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnou ncements/2007/ucm108938.htm. Retrieved 2010-0604. ^ Pharmaceutical Press. "Rules and Guidance for Pharmaceutical Manufacturers and Distributors - Edition: 2007" Retrieved 2010-03-01. ^ http://mohfw.nic.in/ Bankar Lachman ansel
www.bpharmstuf.com 38
www.bpharmstuf.com
39
www.bpharmstuf.com
40