This document provides an introduction to Good Manufacturing Practices (GMP). It defines GMP as a set of principles and procedures that help ensure therapeutic goods manufactured will have the required quality. GMP was first established in the US in 1963 to ensure drugs are consistently manufactured and controlled to quality standards for their intended use. The objectives of GMP are to produce products that conform to predetermined specifications, are of consistent quality, and minimize contamination and errors. Key aspects of GMP include having trained employees, documented processes, adherence to standard operating procedures, clean premises, and quality assurance testing of products before distribution.

1. GOOD
MANUFACTURING
PRACTICES
Presented by-
NOUMAN MOMIN
T.Y.Bpharm (5th semester)
KRISHNA INSTITUTE OF PHARMACY KARAD

2. CONTENT
Introduction
Objective
Parameters
Principle
Conclusion

3. INTRODUCTION TO THE TOPIC
According to FDA a drug is defined as adulterated if the methods
used in its manufacture or processing i.e..
o Testing
o Packaging
o Storing
Does not confirm to the GMPs
 As a result of this GMPs were first established in JUNE 1963.
 The concept was born in USA.

4. Drug being a very important component of health care
system need special attention in regards to their
 QUALITY
 SAFETY
 EFFICACY

5. ???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 to
ensure that the products manufactured will have the
required quality.

6. The Government of India amended the drugs and
cosmetics rules 1945 on 24th JUNE 1988 and prescribed
GMPs under schedule M
For homeopathic drugs schedule is M1
For cosmetics schedule is M2
For medical devices schedules is M3

7. OBJECTIVES OF GMP
TO PRODUCE PRODUCTS CONFORMING TO THE PRE
DETERMINED SPECIFICATIONS.
TO PRODUCE PRODUCTS OF CONSISTENT QUALITY
TO MINIMIZE CONTAMINATION
TO ELIMINATE ERRORS

9. 1. PEOPLE
• All employees are expected to strictly stick to manufacturing
processes and regulations.
• A GMP training must be undertaken by all employess to fully
understand their roles and responsibilities.
2. PRODUCTS
• All products must undergo constant testing, comparison and
quality assurance before distributing to consumers.
• The standard method must be observed for packing, testing and
allocating sample products.

10. 3. PROCESS
• Process should be properly documented (records), clear, consistent and
distributed to all employees.
• Regular evaluation should be conducted to ensure all employees are
complying with the current processes andmeeting the standard
quality.
4. PROCEDURES
• A procedure is a set of guidelines for undertaking a critical process.
• It must be laid out to all employees and followed consistently.
• Any deviation from the standard procedureshould be reported
immediately and investigated.

11. 5. PREMISES
• Premises should promote cleanliness at all time to avoid cross-
contamination, accidents or even fatalities.
• All equipment should be placed or stored properly
• Calibration of equipment regularly to ensure they are fit for
the purpose of production

12. Principles of good
manufacturing practices

13. Wash your hands
• BEFORE STARTING
• AFTER BREAKS
• AFTER USING
WASHROOMS
• AFTER EATING
• AFTER HANDLING
CHEMICALS

15. EATING PROHIBITED
IN PRODUCTION
AREA

16. NO JEWELLERY IN
THE PRODUCTION
AREA

17. CONCLUSIO
N
• The quality of a drug depends on the quality of
those producing it
• Continuous and professional auditing is essential
to overcome the challenge of meeting strict
requirements of GMP
• GPM is doing the right thing when nobody is
watching but it will reflect in the final product
being right.
• In matter of GMP , Swim with the current and in
matter of quality stand like a rock.

18. THANKYOU