应城Quality control measures in the manufacturing process of pharmaceutical intermediates

Pharmaceutical intermediates are an important link in the process of manufacturing drugs, and quality control is crucial. The following will introduce the quality control measures in the manufacturing process of pharmaceutical intermediates.

1、 Raw material quality control

In the manufacturing process of pharmaceutical intermediates, the quality of raw materials directly affects the quality of the final product. Therefore, special attention needs to be paid to the quality control of raw materials. Common raw material quality control measures include:

1. Establish a qualified supplier list: Establish a supplier quality evaluation system, conduct strict qualification audits on suppliers, and ensure the reliable source of raw materials.

2. Quality inspection before raw material procurement: Conduct acceptance inspection on the purchased raw materials, including inspection of appearance, purity, impurity content, microbial load, etc., to ensure that the raw materials meet the specified quality requirements.

3. Control of raw material storage conditions: Strictly control the storage conditions of raw materials to ensure that they maintain appropriate temperature, humidity, and lighting conditions during their shelf life.

2、 Reaction process control

The reaction process is one of the key links in the manufacturing process of pharmaceutical intermediates. The control of the reaction process can effectively ensure the stable quality of intermediates. Quality control measures include:

1. Reaction condition control: including the control of temperature, pressure, reaction time and other conditions to ensure the stability of the reaction process.

2. Reaction process monitoring: Real time monitoring of parameter changes during the reaction process through online detection, sampling, and other means, and timely adjustment of experimental conditions to ensure the smooth progress of the reaction.

3. Impurity removal control: During the reaction process, timely remove the generated impurities to avoid the impact of impurities on the quality of the intermediate.

3、 Purification process control

The purification process is one of the key links in the manufacturing process of pharmaceutical intermediates, and controlling the purification process can effectively improve the purity of intermediates. Quality control measures include:

1. Choose an appropriate purification method: Select an appropriate purification method based on the physicochemical properties of the intermediate, such as crystallization, distillation, extraction, etc., to ensure the purity of the intermediate.

2. Set reasonable operating conditions: control conditions such as temperature, pressure, and solvent selection to ensure the stability of the purification process.

3. Process monitoring: Real time monitoring of the purification process, such as monitoring the purity of intermediates through online detection methods, adjusting operating conditions in a timely manner, and ensuring the quality of the purification process.

4、 Product quality control

Finally, quality control should be carried out on the prepared pharmaceutical intermediates to ensure stable product quality. Specific measures include:

1. Product quality testing: Conduct comprehensive quality testing on the prepared intermediates, including appearance, purity, impurity content, microbial load, and other aspects.

2. Verification of testing methods: Ensure the accuracy and reliability of quality testing methods, and verify the testing methods, such as accuracy, precision, repeatability, and other aspects.

3. Product storage condition control: Control the storage conditions of the prepared intermediate appropriately to ensure that the product maintains appropriate temperature, humidity, and other conditions during its shelf life.