cGMP AND INDUSTRIAL MANAGEMENT OVERVIEW.pptx

This document presents a summary of the cGMP and industrial management by Miss Priyanka Sharma. In 1969, FDA established CGMPs in the Code of Federal Regulations (CFR) (21 CFR Part 110). cGMP ensures that manufacturing processes are standardized and compliant with regulatory requirements, safeguarding product quality and consumer health. On the other hand, industrial management focuses on optimizing the efficiency, cost-effectiveness, and overall performance of these processes.cGMP refers to the set of regulations and guidelines enforced by regulatory bodies like the U.S. FDA (Food and Drug Administration) to ensure that products are consistently produced and controlled according to quality standards. The two concepts are interlinked, as effective industrial management practices help maintain cGMP standards, ensuring both quality and productivity in manufacturing environments.
Industrial management refers to the practices and techniques used to optimize and oversee production processes, ensuring they are cost-effective, efficient, and meet quality standards.

1. cGMP AND INDUSTRIAL MANAGEME NT Presented by- Priyanka Sharma Class- M. Pharm (Department of Pharmaceutics) Guided to- Prof. Kamal Singh Rathore Sir, HOD College- Bhupal Nobles’ College of Pharmacy, Udaipur BHUPAL NOBLES’ COLLEGE OF PHARMACY, UDAIPUR

2. Content cGMP (Current Good Manufacturing Practices) Objectives of cGMP Policies of cGMP Benefits of cGMP Key Aspects of cGMP Industrial Management Key Aspects of Industrial Management Layout of Buildings Objectives of Plant Layout Types of Plant Layout Cgmp & INDUSTRIAL MANAGEMENT 2

3. cGMP (Current Good Manufacturing Practices) cGMP regulations enforced by the US-FDA . It provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Accordingly, the "C" in cGMP stands for "current," means for updating technologies in GMP. 5P’s of GMP –  People, Processes, Procedures, Products and Premises. The "current" part of cGMP means that manufacturers are required to use the most up-to-date technologies, practices, and equipment to ensure the quality, safety, and efficacy of the products being produced. Cgmp & INDUSTRIAL MANAGEMENT 3

4. Objectives of cGMP cGMP regulations assures that the identity, strength, purity or quality of drug products. Ensures that products are consistently manufactured and controlled to specified quality according to the consumer. Concerned with all aspects of production and quality control. In the manufacture of cosmetic products, overall control and monitoring is required. CGMP & INDUSTRIAL MANAGEMENT

5. Policies of cGMP The purpose of this policy is to ensure compliance with current good manufacturing practice regulations of foods. Department managers are accountable for compliance with this policy and the general manager has final authority concerning any GMP Issue. It is the responsibility of all the involved personnel at every level of the organization to act immediately of a risk of violating this policy is detected. CGMP & INDUSTRIAL MANAGEMENT

6. 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 adulteration. CGMP & industrial management 6

7. Key Aspects of cGMP Quality Management: Ensuring that the product meets its quality specifications at every stage of production. Documentation and Record Keeping: Accurate, traceable records are vital, including batch records, testing results, and equipment maintenance logs. Facility and Equipment Maintenance: Regular cleaning, calibration, and validation of production facilities and equipment. Personnel Training: Ensuring staff are properly trained in cGMP principles and product-specific procedures. Quality Control (QC): Consistent and rigorous testing of raw materials, in-process materials, and finished products. Risk Management: Identifying potential risks in the production process and implementing controls to mitigate them. Validation and Verification: Verifying that systems, processes, and equipment are consistently producing quality products. Sample Footer Text 7 CGMP & industrial management

8. Industrial Management CGMP & industrial management 8 Industrial management refers to the process of planning, organizing, and overseeing the operations of manufacturing facilities to achieve efficient production while maintaining quality, safety, and cost-effectiveness. It includes various management activities such as production planning, supply chain management, process optimization, cost control, and workforce management.

9. Key Aspects of Industrial Management CGMP & industrial management 9 Production Planning and Scheduling Supply Chain Management Cost Control Process Optimization Maintenance Management Human Resource Management Health, Safety, and Environmental Management

10. Layout of Buildings It is the organized properly planned inter-department & intra-department arrangement. Proper layout increase productivity and help proper utilization of man, material, method & machines. It is the arrangement of machines, equipment and other physical facilities in a planned manner. CGMP & INDUSTRIAL MANAGEMENT

11. Objectives of Plant Layout Effective utilization of installed machinery and manpower. Minimize the risks of error. Permit effective maintenance and sufficient work space for a better work environment. Avoid cross contamination, build-up of dust and dirt. Avoid any adverse effect on the quality of products. Reduction in manufacturing time and labour cost. It facilitate production process, minimize material handling, time & cost allows flexibility in operations. CGMP & INDUSTRIAL MANAGEMENT

12. Types of Plant Layout . CGMP & industrial management 12 1. Product or Line Layout- If all the machines are arranged in a line sequence according to the sequence of operations of the products then it is known as Product or Line Layout. In this arrangement each following machine or section is arranged to perform the next operation that is performed by its preceding machine or section. This type of layout is suitable for mass production and good for the continuous production system. Advantages- Low material handling cost. Less work in progress. Better utilisation of machine and manpower. Lesser time in production. Less space requirement. Minimum possible cost of manufacturing.

13. CGMP & industrial management Disadvantages- No flexibility. Breakdown of any machine in the line may shut down the whole production line. Difficulty in increase the production beyond the capacities of the production lines. If the output rate of one machine is slower than the other machine, over all production rate decreases . 2. Process or Functional Layout- All the similar machines are positioned together so that all the similar operations are performed at the same place. Machines are arranged according to the nature or type of the operations or their functions. This type of layout is useful where low volume of production is needed.

14. CGMP & industrial management There is no need for layout change for different types of products. Breakdown of any machine can be easily handled by transferring work to another machine and does not affect the production of other machines. Load distribution is easily controlled. Improved product quality because of separate supervisors and workers for all types of machines. Advantages- Disadvantages- High cost of material handling and cost of supervision. Large space required. Production time longer. More floor area is required. High investment required for inventory.

15. CGMP & industrial management 15 3. Fixed or Position Layout- The major part of a material remains at a fixed position and all accessories, material, required tools, machinery and other supporting equipment are brought to this location and this layout is also known as project layout. This layout is good for extremely large items manufactured in very small quantities. Advantages- Less material and workers movement. Less capital investment. Highly flexible for varieties of products. Ensures continuity. Less production cost.

16. CGMP & industrial management Complicated fixtures. Required highly skilled manpower. Movement of machines is time consuming. Machines are not fully utilized. It is limited to large items only. Disadvantages- 4. Combination Layout- Also known as group layout. In this layout we use a combination of all above layouts. These days most of the manufacturing industries have adopted this kind of layout.

17. CGMP & industrial management Reduction in cost of material handling and machine set-up time. Elimination of excess work-in-process inventory. Simple production planning functions. Smooth flow of work. Advantages- Disadvantages- Change of the existing layout is costly and time consuming. Including new components requires thorough analysis. Complex to use.

18. Thank you CGMP & industrial management 18 Presented by- Priyanka Sharma Email address- [email protected] LinkedIn Profile- www.linkedin.com/in/priyanka-sharma-b92058233