Current Good Manufacturing Practices(cGMP) and industrial management

it covers definitions of GMP, cGMp, objectives of cGMP, benefits, plant layout, equipment maintainance, etc.

1. Presented by: Mahewash A. Pathan . c GMP AND INDUSTRIAL MANAGEMENT

2. GMP “ GMP is a system for ensuring that the products are consistently produced & controlled according to quality standards ”. - it is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product . "

3. cGMP:- “cGMP refers to current Good Manufacturing Practices regulations enforced by U.S. Food & Drug Administration. cGMP provides a system that assure proper design, monitoring, & control of manufacturing processes & facilities ”. Announced by FDA in Aug 2002. FDA's cGMP practice steering committee.

4. Objectives & policies of cGMP 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. CFR, published by federal Gov, contains 50 chapters. Chapter 21 of CFR is for Food & Drug manufacturing. Part 210 : cGMP in manufacturing, processing, packaging, or holding of drugs. Part 211: cGMP for finished pharmaceuticals. Part 211 is further divided into 11 subparts, A to K.

6. cGMP covers : General consideration Personnel Premices Equipment Sanitation SOP’s Raw material Self inspection and audits MFR’s BMR’s Warehousing area Labels and other printed material QA

7. Benefits of cGMP They outline a Quality system that reduces errors. Ensures products are safe for use in humans. Minimizes variations in potency of drug. Prevent side effects. Prevent mislabeling and adultratio n.

8. Layout of buildings It is the organized properly planned interdepartment and intradepartment arrangement. Proper layout increases productivity and help proper utilization of- Man Material Money Machines

9. Importance of plant layout It is long term commitment. It facilitates the production process, minimizes material handling, time & cost,& allows flexibility of operations . It facilitates easy production flow, makes economic use of the builiding, promotes effective utilization of manpower, & provides for employee’s convenience, safety, comfort at work, maximum exposure to natural light & ventilation. It affects the flow of material & processes, labour efficiency, supervision & control, use of space & expansion facilities.

10. Layout of buildings designed according to cGMP which ensures Prevention of cross contamination Proper air handling system Proper cleaning & sanitary conditions. Proper lighting Proper plumbing Proper washing.

11. Objectives of plant layo ut Proper & efficient utilization of available floor space. Provide enough production capacity. Reduce material handeling cost. Reduce hazard to personnel. Utilize labor efficiently. reduce accidents. Provide ease of supervision & control. Provide employee safety & health. Allow easy of maintainance. Better interdepartment relationship.

12. Types of layout Circular flow Parallel flow Crossover traffic

13. Buildings & facilities Design and constructions Floor Roof system Water Containers Lighting Sewage and refuse Sanitations and maintenance.

14. Equipment Should be selected based on the intended use and cleanability. Must be placed in an appropriate location. Must be properly qualified (design, installation, operation, performance). Constructed so that, surfaces are non reactive. Automatic, mechanical & electronic equipments should be calibrated, inspected or checked as per written program to assure proper performance. Computer input/output checked for accuracy.

15. Equipment maintenance Weighing, measuring, testing & recording equipment should be serviced & calibrated regularly. All records should be maintained. Written procedures should include- Responsibility for equipment cleaning & maintenance. Cleaning & sanitizing schedules. Detailed description of cleaning. Removal of previous batch identification. Protection of clean equipment Inspection of equipment prior to use.