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 like WHO , FDA and EU. These guidelines have recommendations for almost all departments of pharmaceutical companies like manufacturing, quality control, storage and distribution.
Components of GMP (Good Manufacturing Practices) includes:
1. 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.
2. 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.
3. Materials
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.
4. Manufacturing Process
There must be a well-defined and controlled manufacturing process. Manufacturing process should be validated . Out of specification results and deviations must be investigated and addressed appropriately.
5. 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.
Two more essential comonents of GMP
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 like 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.
Quality Management System (QMS)
It is essential to establish a strong quality management system to control the processes, procedures and responsibilities to ensure the production of quality products by handling documentation, change control, deviation and other quality related incidents in properly controlled manner.
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