GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products. There are several guidelines for good manufacturing practices worldwide but GMP guidelines provided by WHO and FDA are followed worldwide. These guidelines have recommendations for almost all departments of pharmaceutical firms like manufacturing, quality control, storage and distribution. Good Manufacturing Practices in pharmaceutical has following 14 components.
2. Personnel: Personnel working in the manufacturing and quality control should be properly trained and qualified for work they are responsible. Their jobs and responsibilities should be documented and training of their respective role must be documented.
3. Facilities and Equipment: Facilities and equipment must meet the GMP requirements for pharmaceuticals. Facility must support to protect the product from contamination and should be clean. Facility must have suitable manufacturing area, storage area and utilities like water system, HVAC system and cleanrooms. Equipment installed in manufacturing area must be qualified, installed and maintained to prevent the product from contamination.
4. Sanitation and Hygiene: According to GMP it is essential to maintain a clean and hygienic manufacturing area for drug products. This component of GMP includes the regular cleaning and sanitization of the facility and equipment, a well-defined waste disposal procedure and implementation of personal hygiene practices including the use of personal protective equipment and hand hygiene.
6. Raw Material and Components: In a GMP facility, there is a strict control over the raw material and other components used in manufacturing. There should be a well-defined procedure for receipt, sampling and storage to ensure the quality, identification and use of the manufacturing components. There should be proper control during handling and storage of raw material to prevent it from contamination and mix-ups.
7. Manufacturing Process: There must be a well-defined and controlled manufacturing process. Manufacturing process should be validated to demonstrated the products meet a predetermined quality specification. Manufacturing process must be controlled by implementing the process checks to ensure the process runs in defined limits. Out of specification results and deviations must be investigated and addressed appropriately.
8. Packaging and Labeling: GMP also covers the packaging and labelling of the pharmaceutical products. Packaging material should be of good quality and well controlled. Packaging process should be validated and labels should comply the regulatory requirements. Labelling information, dose strength and storage conditions should be accurate and clearly readable. Any warning or precaution regarding the dose or product should be clearly written on the label of the product.
10. Product Complaints and Recalls: It is necessary to have a stablished procedure for handling the market complaints related to the products and their proper investigation. Investigation of product complaints includes the monitoring, investigation of root cause and proper implementation of corrective and preventive actions. If a defective product has any risk to patient safety the GMP required to have a product recall system. It required a documented product recall system that has steps to be followed during the product recall activity and communication to the suppliers and other stakeholders.
11. Validation and Qualification: It is also a very critical component of the GMP. All processes, systems and equipment used in the manufacturing process must be validated to ensure the stability for intended use and consistent performance. It includes the process validation, equipment IQ, OQ and PQ, cleaning method validation, analytical method validation, water system validation and area qualification. All qualification and validation activities must be documented to demonstrate the performance of the process and systems.
13. Audits and Inspections: Regular audits and inspections plays an important role in GMP compliance. Internal audits are conducted by the company itself to evaluate the state of compliance. It helps to identify the area of improvements and proper implementation of corrective and preventive actions. External audits are conducted by the regulatory agencies to assess the GMP compliance of the company. Audits and inspections are necessary for the company to identify non-compliance and continuous improvement in the manufacturing process.
14. Training and Continuous Improvement: These are ongoing components of GMP. All the employees must be well trained for their respective jobs. A well-defined training program must be there to ensure that all employees are trained on GMP requirements, principles and procedures they follow. Regular training sessions must be conducted to keep the employees informed about the current regulatory changes. New initiatives must be taken to improve the manufacturing process and product quality like conducting risk assessments, implementation of corrective actions and monitoring the process performance.
2. Personnel: Personnel working in the manufacturing and quality control should be properly trained and qualified for work they are responsible. Their jobs and responsibilities should be documented and training of their respective role must be documented. 3. Facilities and Equipment: Facilities and equipment must meet the GMP requirements for pharmaceuticals. Facility must support to protect the product from contamination and should be clean. Facility must have suitable manufacturing area, storage area and utilities like water system, HVAC system and cleanrooms. Equipment installed in manufacturing area must be qualified, installed and maintained to prevent the product from contamination.
4. Sanitation and Hygiene: According to GMP it is essential to maintain a clean and hygienic manufacturing area for drug products. This component of GMP includes the regular cleaning and sanitization of the facility and equipment, a well-defined waste disposal procedure and implementation of personal hygiene practices including the use of personal protective equipment and hand hygiene.
6. Raw Material and Components: In a GMP facility, there is a strict control over the raw material and other components used in manufacturing. There should be a well-defined procedure for receipt, sampling and storage to ensure the quality, identification and use of the manufacturing components. There should be proper control during handling and storage of raw material to prevent it from contamination and mix-ups.
7. Manufacturing Process: There must be a well-defined and controlled manufacturing process. Manufacturing process should be validated to demonstrated the products meet a predetermined quality specification. Manufacturing process must be controlled by implementing the process checks to ensure the process runs in defined limits. Out of specification results and deviations must be investigated and addressed appropriately.
8. Packaging and Labeling: GMP also covers the packaging and labelling of the pharmaceutical products. Packaging material should be of good quality and well controlled. Packaging process should be validated and labels should comply the regulatory requirements. Labelling information, dose strength and storage conditions should be accurate and clearly readable. Any warning or precaution regarding the dose or product should be clearly written on the label of the product.
10. Product Complaints and Recalls: It is necessary to have a stablished procedure for handling the market complaints related to the products and their proper investigation. Investigation of product complaints includes the monitoring, investigation of root cause and proper implementation of corrective and preventive actions. If a defective product has any risk to patient safety the GMP required to have a product recall system. It required a documented product recall system that has steps to be followed during the product recall activity and communication to the suppliers and other stakeholders.
11. Validation and Qualification: It is also a very critical component of the GMP. All processes, systems and equipment used in the manufacturing process must be validated to ensure the stability for intended use and consistent performance. It includes the process validation, equipment IQ, OQ and PQ, cleaning method validation, analytical method validation, water system validation and area qualification. All qualification and validation activities must be documented to demonstrate the performance of the process and systems.
13. Audits and Inspections: Regular audits and inspections plays an important role in GMP compliance. Internal audits are conducted by the company itself to evaluate the state of compliance. It helps to identify the area of improvements and proper implementation of corrective and preventive actions. External audits are conducted by the regulatory agencies to assess the GMP compliance of the company. Audits and inspections are necessary for the company to identify non-compliance and continuous improvement in the manufacturing process.
14. Training and Continuous Improvement: These are ongoing components of GMP. All the employees must be well trained for their respective jobs. A well-defined training program must be there to ensure that all employees are trained on GMP requirements, principles and procedures they follow. Regular training sessions must be conducted to keep the employees informed about the current regulatory changes. New initiatives must be taken to improve the manufacturing process and product quality like conducting risk assessments, implementation of corrective actions and monitoring the process performance.
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