Good manufacturing practices

THE BASICS CONCEPT OF GMP ( GOOD MANUFACTURING PRACTICES)

1. Good manufacturing practices Presented by- NOUMAN MOMIN T.Y.Bpharm (5 th 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.. Testing Packaging 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 24 th 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

8. 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.

9. 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.

10. 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

11. Principles of good manufacturing practices

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

13. EATING PROHIBITED IN PRODUCTION AREA

14. NO JEWELLERY IN THE PRODUCTION AREA

15. CONCLUSION 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.

16. THANKYOU