Good Manufacturing Practices (GMP), Introduction, objective & principles of GMP

GMP
Objective & Purpose
5 P’s of GMP
Principle of GMP

1. Mr. Vinayak R. Bodhankar Asst. Professor, Ph.D. Scholar M. Pharm. ( QA )

2. 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. Introduction

3. Objective Guarantee high quality products to the consumer Delivering products free of all possible contamination. Purpose of GMP Here’s why Good Manufacturing Practices need to be adhered to: To prevent any damage caused to consumers’ health due to consumption. To avoid any harmful skin problems caused due to product application. To define and control hygiene protocols. To maintain facilities for improved processes and production environment. To cut down the loss of money. To cut down the number of complaints.

4. 5 P’s of GMP

5. All the employees are expected to strictly stick to manufacturing processes and regulations. A GMP training must be undertaken by all employees to fully understand their roles and responsibilities. All products must undergo constant testing, comparison and quality check before distribution to consumers. The standard method must be observed for packing, testing and allocating sample products. Process should be properly documented, clear, consistent and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current process and meeting the standard quality. PEOPLE PRODUCTS PROCESS

6. A procedure is a set of guidelines for undertaking a critical process. It must be understand by all the employees and followed consistently. Any deviation from SOP should be reported immediately and investigated. Premises should promote cleanliness at all time to avoid cross contamination, accidents or even fatalities. All equipment's should be placed and stored properly. Equipment's should be regularly calibrated to ensure that they are fit for their intended use. PROCEDURES PREMISES

7. 10 principles of GMP These 10 principles forms the foundation of GMP and are designed to provide a structure for a strong quality management system (QMS). They helps to ensure that pharmaceutical products are consistently high in quality, safe, and fit for their intended use. Written procedures and instruction Facilities and equipment's Materials Production Quality control Documentation Personnel Validation and change control Complaints and recall Auditing

8. 1. Written Procedures and Instructions: Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process. 2. Facilities and Equipment: Facilities and equipment should be properly designed, maintained, and cleaned to ensure the quality of products. Equipment validation and calibration are also crucial for maintaining consistent operations.

9. 4. Production: Manufacturing processes are clearly defined, controlled, and validated to ensure consistency and compliance. Critical processes are validated to demonstrate that they are capable of consistently delivering quality products. 5. Quality Control: Products must be tested at different stages of production to verify quality. These tests should ensure the identity, purity, potency, and quality of the product. 3. Materials: All materials used in a manufacturing process must be of tested quality, clearly identified, and readily traceable. This includes both the product’s ingredients and the specific containers and closures that will be used.

10. 7. Personnel: Qualified and adequately trained personnel are essential. Every person involved in manufacturing should have the education, training, and experience to perform their role effectively. 6. Documentation: Records, raw data, and documents related to production and distribution should be retained and available for review. They should be clear, comprehensive, and accurate.

11. 9. Complaints and Recalls: There should be systems in place for handling complaints and product recalls. This involves reviewing and investigating complaints and taking appropriate corrective actions when necessary. 10. Auditing (Self-inspection and Quality Audits): Regular audits should be conducted to ensure that GMP guidelines are being followed. These audits can identify areas for improvement and ensure that corrective actions are implemented. 8. Validation and Change Control: Changes to the manufacturing process must be properly reviewed, validated, and documented to ensure the quality of the product isn’t compromised.