The Methods and Quality Requirements of API Pharmaceutical Production

The production process of active pharmaceutical ingredients has its own characteristics compared to the production of pharmaceutical preparations: Active pharmaceutical ingredient manufacturing often involves complex chemical and biological changes, more complex intermediate controls and by-products that require purification. These have led many chemical synthesis companies to develop green chemistry techniques. They hope to help increase production efficiency and reduce costs by incorporating more environmentally friendly green production methods into the synthesis of API pharmaceutical and intermediates.

1. What is API pharmaceutical?

API pharmaceutical refers to the active substances used in the production of preparations, which are the main components processed into preparations, generally by chemical synthesis, DNA recombination technology, fermentation, enzymatic reaction or extraction from natural substances. API pharmaceutical is divided into non-sterile API pharmaceutical and sterile API pharmaceutical. API pharmaceuticals with sterility inspection items in the quality standard are sterile API pharmaceuticals. Sterile raw materials are often used in injections and can usually be directly subpackaged into injections. Injectable API pharmaceutical is not necessarily sterile API pharmaceutical.

2. Methods and quality requirements for API pharmaceutical production

API pharmaceutical production basically adopts the intermittent production method: intermittent batch production means that in the production process, each unit needs to be tested after the production is completed, and the next unit can only be entered after passing the test. The process stages and times corresponding to the input to output of a batch of products are highly consistent. Once a product is found to be unqualified in one link, all products in the same batch will be regarded as unqualified and will be sampled for re-inspection. This method is mainly used for the manufacture of active pharmaceutical ingredients.

As an example of green chemistry technology, continuous reaction can be put into process synthesis and can safely complete some high-risk reactions that cannot be completed by traditional batch reactors. Processing is required to ultimately produce the final product for the market. The production relies on modern control methods and reliable and stable technological processes to ensure consistent quality of the final product. Looking for api active pharmaceutical ingredient? Pharmasources would be a great platform for you to get various types of active pharmaceutical ingredients.

API pharmaceutical production should meet strict quality requirements: quality is an important indicator related to API pharmaceutical production. If the quality of API pharmaceutical is not guaranteed, it will directly affect the quality of subsequent medicines. Through the analysis of the production process of active pharmaceutical ingredients, it can be concluded that the impurity map, quality assurance system and sterile API pharmaceutical of API pharmaceutical must be checked to ensure the purity of the drug and avoid secondary pollution of API pharmaceutical.