3. An Over View
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash –How and when
Training & Practice
4. Hygiene meaning
Collins Dictionary:
Hygiene is the practice of keeping your self and your
surroundings clean, especially in order to prevent
illness or the spread of diseases
Cambridge Dictionary:
The degree to which people keep themselves or their
environment clean, especially to prevent disease
5. DEFINITION
Contamination:
The undesired introduction of impurities of a chemical or
microbiological nature, or of foreign matter, into or onto a raw
material, intermediate, or API during production, sampling,
packaging or repackaging, storage or transport.
Cross-Contamination:
Contamination of a material or product with another material or
product.
6. CONTAMINATION CONTROL
API as well as drug product manufacturing area, specifically
clean room has to be designed and maintained to prevent or
minimize the contamination from microorganisms,
particulates etc Objective is
To ensue the Patient safety (contamination = risk to the patients)
To ensure quality, purity, safety and efficacy of the product
To comply GMP and Regulatory Requirement
Minimize the product defective / failure
Quality of product should be built into design and systems during
manufacturing,
7. SOURCES & CONTROL OF CONTAMINATION
Source Possibility of contamination Reduce / Elimination of
contamination
Personnel Improper gowning, not washing
hands properly, Lack of cleanliness,
Working with illness, etc
Hygiene procedure, Gowning, hand
washing, use of PPEs, Training,
Practice,
Environ-
ment
Lack of design, control &
monitoring. Open and access to bird
and vermin
Facility , HVAC design, Clean room,
Air filtration, Cleaning, Operation
and Maintenance
Equipment Unsuitable equipment, Lack of
cleaning/not easy to clean
Cleaning, Maintenance
Material Improper control of material.
Receipt, storage and transfer, et
Restriction, de-dust/ de-
contamintion.
8. GOOD MANUFACTURING PRACTICE
Q7 Good Manufacturing Practice emphasis the requirements to
Prevent contamination and cross-contamination by practicing
Good personnel hygiene and sanitization.
It is mandatory and to ensure the compliance
To ensue Product quality and avoid rejection
To employee safety
To avoid recall and complaints
To avoid warning letter / import alert
To avoid loss of business
9. ICH Q7: 3.2. PERSONNEL HYGIENE
3.20 Personnel should practice good sanitation and health habits.
3.21 Personnel should wear clean clothing suitable for the
manufacturing activity with which they are involved and this clothing
should be changed when appropriate. Additional protective apparel, such
as head, face, hand, and arm coverings, should be worn when necessary, to
protect intermediates and APIs from contamination.
3.22 Personnel should avoid direct contact with intermediates or APIs.
3.23 Smoking, eating, drinking, chewing and the storage of food should be
restricted to certain designated areas separate from the manufacturing areas.
10. 3.24 Personnel suffering from an infectious disease or having open lesion
son the exposed surface of the body should not engage in activities that could result
in compromising the quality of APIs.
Any person shown at any time (either by medical examination or supervisory
observation) to have an apparent illness or open lesions should be excluded from
activities where the health condition could adversely affect the quality of the APIs
until the condition is corrected or qualified medical personnel determine that the
person's inclusion would not jeopardize the safety or quality of the APIs.
11. 21CFR§211.28 REQUIREMENT
Personnel responsibilities.
a) Personnel engaged in the manufacture, processing, packing, or holding
of a drug product shall wear clean clothing appropriate for the duties they
perform. Protective apparel, such as head, face, hand, and arm coverings,
shall be worn as necessary to protect drug products from contamination.
b) Personnel shall practice good sanitation and health habits.
c) Only personnel authorized by supervisory personnel shall enterthose
areas of the buildings and facilities designated as limited-access areas.
12. PERSONNEL RESPONSIBILITIES.
d)Any person shown at any time (either by medical examination or supervisory observation) to
have an apparent illness or open lesions that may adversely affect the safety or quality of
drug products shall be excluded from direct contact with components, drug product
containers, closures, in-process materials, and drug products until the condition is corrected
or determined by competent medical personnel not to jeopardize the safety or quality of drug
products.
All personnel shall be instructed to report to supervisory personnel any health conditionsthat
may have an adverse effect on drug products.
13. MANUFACTURING CONTROL
1.Written procedures are established and followed
- master formula, manufacturing record and packaging record
2. Critical Process are validated
QUALITY CONTROL DEPARTMENT
1. Testing of bulk components prior to use by production
2. Testing of finished product prior to release for sale
3. Stability Program
14. RECORDS
1. Document all GMP activities
2. Use Good Documentation Practice (GDP)
3. Records must be readily available
GOOD DOCUMENTATION PRACTICE
Documentation must be:
1. Permanent (Black or Blue Ink)
2. Clear, Legible
3. Accurate
4. Timely, Complete
15. STABILITY
1. Establish the length of time in which the product meets all
specification
2. Monitor the drug for this period of time
STERILE PRODUCTS
1. Packaged in separate enclosed area by trained personnel
using method to ensure sterility
16. STORAGE
1. No materials should be stored on floor.
2. All materials to be labeled (Name, Mfg. date, Exp. Date,
Batch no. etc ).
3. Continuous temperature monitoring device should be applied
to any critical storage area, like cold room.
17. 1. GMP in solid dosage forms
2. GMP in semisolid dosage forms
3. GMP in liquid orals
4. GMP in parenteral production
5. GMP in ayurvedic medicines
6. GMP in bio-technological products
7. GMP in nutraceuticals and cosmeceuticals
8. GMP in homeopathic medicines
GMP IN…….
18. Abbreviation Elaboration
SOP Standard Operating Procedures
STP Standard Testing Procedure
BMR Batch Manufacturing Record
API Active Pharmaceutical Ingredient
FIFO First In First Out
FEFO First Expire First Out
HVAC Heating, Ventilation and Air Conditioning
HEPA High Efficiency Particulate Air Filter
OOS Out of Specification
19. WHY GMP IS IMPORTANT
1. A poor quality medicine may contain toxic substances
that have been unintentionally added.
2. A medicine that contains little or none of the claimed
ingredient will not have the intended therapeutic
effect.
