In this slides you knowing about the current good manufacturing practices, there are playing crusial role in a pharmaceutical industry. In which slides cover the cgmp objective and location of industry and follow guidelines

1. CURRENT GOOD
MANUFACTURING
PRACTICE
Present by
Mr. Vishal Prajapati

2. CONTENT
 Introduction
 Objective
 Components of CGMP
 Areas to be covered

3. INTRODUCTION
 CGMP refers to Current Good Manufacturing
Practices regulation enforced by USA FDA
 CGMP provides system that assures proper design,
monitoring and control on manufacturing process
and facilities.
 CGMP regulation assure the identity, strength,
quality and purity of drug product by requiring that
manufacturer of medication adequately control
manufacturing operations.

4. OBJECTIVE
 Ensure that products are consistently
manufactured and controlled to the specified
quality.
 concerned with all aspects of production and
quality control.
 In the manufacture of cosmetic products, overall
control and monitoring.
 ensure that the consumer receives products of
specified quality.

5. COMPONENTS OF CGMP
 CGMP is a part of QA
 Main function of CGMP is to produce quality product
consistently.
 CGMP must meet both production and QA related
issues.
 CGMP must meet legal requirements of country.
 CGMP further comments that main function of GMP is
avoid mix-ups and Contamination.

6. CGMP covers
 General considerations
 Personnel
 Equipment
 Sanitization
 SOP’s
 Raw material
 Master formula record
 Batch manufacturing record
 Warehousing area
 Labels and other printed
 QA

7. General considerations
 Compliance with GMP
 Consistent uniform batches.
 Location and surounding.
 Water system.
 Disposal of waste.

8. Personnel:
 Qualified person:
•Experience
•Sufficient number
 Written job description.
 Trained.
 Health:
•Disease.
•Open lesion.
•Skin disease.
•Allergic reaction.

9. Equipmement-
 Equipment’s shall be located, design and
constructed to suit theoperation to be carried
out.
 Should be made up of non reactive material.
Location-
Geography, Climate, economical factor,
neighbourers Premises must be located to minimize
the risk of cross contamination.

10. Design:
 Maintain risk of errors.
 Permit effective cleaning
 Permit effective maintenance.
 Avoid cross contamination.
 Maximum protection against entry of insect,
birds, animals.
Hygiene and sanitization:
 Eating, drinking, smoking should not be allowed in
production area
1. Sanitization
2. Washing and toilet facilities
3. Maintenance
4. Plumbing
5. Sewage and refuse

11. Raw material:
 Record should be maintained as per schedule U.
 Purchased from approved source.
 Must checked by QC department
 Should be labelled

12. Packaging And Labelling Control:
1.Material examination and usage criteria:
 Record shall be maintained for each different
labelling and packaging material
 Labels and labelling material for different drug
products, strength, dos age form shall bestored
separ ately with suitable identification.
2.Packaging and labelling operation:
 Should examine for suitability and correctness.
 Should be documented in batch production
record.

13. The conditions satisfied by the
warehousing area are as follows:
 Good storage condition.
 Clean and dry.
 Acceptable temperature limit.
 Good sanitization.
 Separate Sampling area.
 Fire prevention.
 Properly labelled material

14. Thank
You