Components of GMP : GMP in Detail : Pharmaguideline

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Components of GMP : GMP in Detail

These guidelines have recommendations for almost all departments of pharmaceutical firms like manufacturing, quality control, storage and distribution
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.

1. Quality Management System (QMS): It is essential to stablish a strong quality management system to control the processes, procedures and responsibilities to ensure the production of quality products. Quality management system is responsible to achieve the good manufacturing practices by handling documentation, change control, deviation and other quality related incidents in properly controlled manner.

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.

5. Documentation and Record Keeping: Accurate and complete documentation is essential in pharmaceuticals. It is a critical component of the good manufacturing practices. It is required to follow the ALCOA principles which includes control of various documents lick batch manufacturing records, SOPs, specifications, protocols and reports. All data related to raw material, manufacturing process and quality control should be properly recorded and retained.

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.

9. Quality Control: It is very crucial component od the good manufacturing practices and involves the testing and analysis of the products. Raw material, in-process samples and finished products are tested to ensure that the product meets the predefined specification of the product or the manufacturing stage. Quality control laboratory should be well equipped with all required instruments like HPLC, GC, Spectrophotometer etc. and analysts must be qualified and well trained for the analysis of the products. All test methods and procedures used for analysis must be validated.

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.

12. Change Control: Change control is used to manage a change in any system or procedure. Any change that can impact the quality, safety and efficacy of the product must be documented. A formal change control procedure must be there to implement any change in processes, equipment, materials, facility or system. Impact of the proposed change and its effectiveness must be evaluated.

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.

Basically, the manufacturer must document all the activities of the warehouse, manufacturing and quality control laboratories. All the above components of GMP can help the company to comply with the GMP regulations that will help the company to avoid the warning letter and import bans. Compliance of the good manufacturing practice recommendations on tony help the manufacturer but it also protects the health of the customers.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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