Views: 34 Author: Site Editor Publish Time: 2023-04-18 Origin: Site
Active pharmaceutical ingredients (APIs) are the key components in medications that provide therapeutic benefits to patients. The manufacturing process for these crucial compounds is complex and involves a number of stages, each of which plays a critical role in ensuring the quality and purity of the final product.
In this article, we will explore how APIs are manufactured, from the initial synthesis of the chemical compounds to the final purification and packaging. Understanding this process is essential for anyone working in the pharmaceutical industry, as it ensures that medications are safe and effective for patient use.
The raw materials of API drugs generally refer to active pharmaceutical raw materials, also known as active pharmaceutical ingredients (APIs). The quality, source of supply and purity of API raw materials are all very important.
The quality of API raw materials generally refers to their compliance with the requirements of GMP (Good Drug Management Practice), which mainly includes the appearance, quality, structure, components, activity, solubility, toxicity and stability of raw materials.
There are generally two sources of supply of API raw materials, one is domestic suppliers and the other is foreign suppliers. The API raw materials of domestic suppliers are generally produced according to the national GMP standard, and the quality can be guaranteed; while the API raw materials of foreign suppliers are generally produced according to the foreign GMP standard, and the quality can also be guaranteed.
The purity of API raw materials generally refers to the content of active substances in it, usually calculated as a percentage. The higher the purity, the higher the content of active substances and the higher the quality.
1. Drug preparation: Drug preparation is the first step in the manufacture of API drugs. It refers to the preparation process from raw materials to active pharmaceutical ingredients, including the collection, grinding, mixing, fine powder, crushing and disinfection of raw materials.
2. Refining: Refining refers to the fine processing process from raw materials to active pharmaceutical ingredients, including fine powder refining, fine crushing and refining, etc., in order to achieve the best activity and purity of active ingredients.
3. Stability test: Stability test refers to testing the physical properties, chemical properties and biological activities of API drugs to determine their stability under predetermined conditions and their changes under different environmental conditions to ensure its quality stability.
4. Approval: Finally, API drugs need to be reviewed and approved by relevant national agencies before they can be marketed to ensure their quality and safety.
The quality control of API drugs refers to the use of various technical means in the production of API drugs to ensure that their quality meets the requirements to meet their medicinal properties and safety requirements.
Quality control methods employed include:
1. Raw material management: Raw materials must be strictly inspected to ensure their quality meets the requirements;
2. Process control: It is required to adopt effective control technology in the production process to ensure the quality of the process;
3. Inspection and control: It is required to inspect the quality of the product to ensure that the product quality meets the requirements;
4. Environmental control: It is required to adopt effective control technology in the production environment to ensure the quality of the environment;
5. Quality file management: It is required to manage product quality files to ensure the integrity of the files.
Quality control standards include:
GMP (Good Manufacturing Practice for Drugs): It is required that the equipment, raw materials, process, environment, etc. for the production of API drugs must meet the requirements of GMP;
BP (British Pharmacopoeia): The quality of API drugs is required to meet the requirements of BP;
USP (United States Pharmacopoeia): The quality of API drugs is required to meet the requirements of USP;
EP (European Pharmacopoeia): The quality of API drugs is required to meet the requirements of EP.
The production process of API mainly includes melting precipitation method, solvent precipitation method, rectification method, molecular sieve method, catalytic method and co-precipitation method, etc. The manufacturing process includes steps such as material procurement, material inspection, raw material batching, reaction, rectification, separation, liquid separation, crystal separation, crystal crystallization, drying, inspection, and packaging.
The production characteristics of API mainly include:
The details of the production process are strict and the requirements are high;
The production process is complex and the operation technology requirements are high;
The production equipment design is complex and the technical requirements are high;
During the production process A variety of raw materials are involved, which need to be strictly controlled;
The product quality requirements are high during the production process;
Variables need to be strictly controlled during the production process to ensure product quality.
The current market situation of API is good. Due to the development of pharmaceutical manufacturing and R&D technology, the demand for API is also increasing, and the overall development prospect of the industry is good.
The laws and regulations that API needs to abide by in the production process mainly include "Drug Administration Law", "Drug GMP Standards", "Drug Production License", "Drug Registration Certificate", etc.