Active pharmaceutical ingredients (API) are important compounds used in the production of pharmaceutical products. API has biological activity and can be used to treat diseases. The quality of API plays an important role in drug quality. Quality should be built by design.
1. API and excipients. Active pharmaceutical ingredients (API) and excipients
2. Pharmaceutical intermediates. Non segregated intermediates, i.e. intermediates produced and kept in reactor vessels for conversion to final molecules or any other intermediate.
3. Raw materials and reagents.
It can be divided into the following four categories
1. Production facilities of active pharmaceutical ingredients
Safety measurement plays an important role in the manufacturing process of API. Many synthetic routes contain inherently dangerous chemical reactions. Compromise of safety related decisions will undoubtedly lead to fatal accidents and huge property losses. Security means that it is not only about people and property, but also about the environment. It is the responsibility of the manufacturer to protect the environment from chemical pollution.
The next important thing is hygiene and hygiene. Good health habits will lead to a good health culture. Employees in the industry must understand hygiene and the importance of hygiene. Management should provide meaningful training to employees on this topic.
Health and hygiene are not limited to one region. It applies to the entire plant, including personnel. Cleaning floors, walls and ceilings with non polluting liquids or solvents, cleaning remote areas regularly, closing breeding areas, disinfecting clothes and removing stagnant water are examples. Toilets and canteens should be kept away from the production area.
2. The relationship between the quality of raw materials and the quality of active pharmaceutical ingredients
The quality of raw materials is the basis of API quality. The best procedure must be taken to ensure the quality of raw materials, which are identified by the physical and chemical properties and purity of the compounds. The company must conduct regular audit at the raw material supplier's site to ensure the quality. The company shall state the selection process of raw material suppliers based on quality. The poor quality of raw materials eventually leads to poor quality of active pharmaceutical ingredients. Poor quality APIs are unsafe and you cannot use them for therapeutic purposes. The analytical method has limitations in the identification of impurities. If any impurities are skipped due to the limitations of laboratory test methods, it will lead to a major disaster.
3. Control of impurities in active pharmaceutical ingredients
Chemicals other than API are called impurities. Impurities may also be formed in other ways. Impurities have no clinical value and can harm patients. The severity of the side effects depends on the nature and type of impurities. There is no chemical synthesis method to produce 100% of the required products. The product is always accompanied by impurities. This is the truth. Impurities can be divided into three types: 1. Organic impurities (impurities related to technology and drugs); 2. Inorganic impurities; 3. Residual solvents.
These impurities will enter the impurity distribution of main products during the manufacturing process. When chemicals get enough energy, they naturally react with other materials. Energy can be in the form of heat or light. The storage of raw materials and API is a key factor to control impurities. When the product is exposed to light, impurities increase due to photochemical degradation. Excessive heat leads to internal reactions and chemical changes, which in turn leads to a path to impurities through thermal degradation. Impurities related to raw materials can enter API and contribute to its impurity distribution. Because they are close enough to the main compounds, they can escape from the purification process. Sufficient analytical methods must be used to detect these impurities in each processing step. This exercise is not limited to raw materials; it is also applicable to by-products, intermediates, reagents, ligands and catalysts that may appear in the API impurity distribution.
Solvents are used as carriers in organic synthesis. They are inevitably used in the preparation of solutions or suspensions. Residues of these solvents are likely to be present in the API impurity distribution. Guidelines have been developed to define the allowable limits for these residual solvents in the impurity distribution of active pharmaceutical ingredients. Impurities can be identified or not identified. There should be clear documentation of possible impurities and their control strategies. Any impurity greater than the identification threshold in any batch shall be identified. Analytical procedures must be developed and validated to identify all potential impurities. Special attention is needed to control genotoxic impurities. These impurities must be tested by appropriate and validated methods.
4. Treatment and storage of active pharmaceutical ingredients
The treatment of raw materials and APIs should be carried out according to the standard procedures. Records must be available for receiving and distributing raw materials and APIs. All raw materials shall be kept in quarantine area until the test is completed. If the material does not meet the predefined specifications, it is moved to an exclusion area where only authorized personnel can be accessed. Proper procedures should be used to identify and sample all raw materials. The API should be stored under appropriate conditions determined by the stability study.
The temperature and humidity control system must be located in the drug storage area. All API records should contain clear details, such as when to receive, how many quantities, batch numbers, to whom the quantity is allocated and the expiration date. Packaging materials should not allow moisture, light and oxygen from the air to enter. It must have the ability to protect materials from biological contamination. All these characteristics of packaging materials shall remain unchanged throughout the shelf life of the product. Poor packaging of API can lead to many serious consequences, such as product deterioration and recall. It has doubts about the company's quality assurance system. Regulators may view this as a serious problem and may review the company's overall quality system.
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