4. GMP:
GMP is a set of regulations, codes and guidelines
for the manufacture of drug substances and drug
products, medical devices, in vivo and in vitro
diagnostic products
5.
6. BASIC PRINCIPLES
1. Manufacturing facilities must maintain a clean and hygienic manufacturing
area.
2. Controlled environmental conditions in order to prevent cross contamination
of food or drug product from adulterants that may render the product unsafe for
human consumption.
3. Manufacturing processes are clearly defined and controlled. All critical
processes are validated to ensure consistency and compliance with
specifications.
4. Instructions and procedures are written in clear and unambiguous language
5. Operators are trained to carry out and document procedures.
6. Cross contamination with unlabelled major allergens is prevented.
7. 7. Records are made, manually or by instruments, during manufacture that
demonstrate that all the steps required by the defined procedures and instructions
were in fact taken and that the quantity and quality of the food or drug was as
expected. Deviations are investigated and documented.
8. Records of manufacture (including distribution) that enable the complete history of
a batch to be traced are retained in a comprehensible and accessible form.
9. A system is available for recalling any batch from sale or supply.
10. Complaints about marketed products are examined, the causes of quality defects
are investigated, and appropriate measures are taken with respect to the defective
products and to prevent recurrence.
8.
9. GMP CATEGORIES
1. Sale
2. Premises & Equipments
3. Personnel
4. Sanitation
5. Raw Material, Packaging Material and Finished Product Testing
6. Manufacturing Control
7. Quality Control Department
8. Record
9. Stability
10. Sterile Product
11. Storage
10. SALE
No distributor and no importer shall sell a drug unless it has
been packaged/ labeled, tested and stored.
PREMISES & EQUIPMENTS
1. Permits effective cleaning
2. Prevent Contamination
11. PERSONNEL
1. Appropriate education, training and experience
2. Sufficient number of people
3. Receive GMP training
SANITATION
Sanitation program to prevent contamination
1. Hi Level of personal cleanliness while in production
facilities.
2. Everyone must wash and sanitize their hands
3. Ware hair cover, washed uniforms and safety shoes
12.
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.
