Introduction to FEI certification and FDA certification for pharmaceutical intermediates enterprises.
FDA certification FEI code refers to the unique identifier that the U.S. Food and Drug Administration (FDA) approves and certifies medical device products. In the medical device industry, the FEI code is critical as it is used to identify and track medical devices to ensure the safety and effectiveness of the product. The Concept and Significance of FEI CertificationFYE Certification is one of the certification systems implemented by the FDA (Food and Drug Administration), the full name is "FacilityEstablishmentIdentifier", that is, the production facility identification number.
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This article will introduce in detail the classification of applicants for FDA certification FEI codes.
Intermediate: An intermediate intermediate: a material produced in the process steps of the API that must undergo further molecular change or refining before it can become an API. Intermediates can be separated or not. (Note: This guidance only covers intermediates that the company defines as being produced after the API manufacturing starting point.) )
Active Pharmaceutical Ingredient (API)(or Drug Substance): A substance or mixture of substances intended for use in the manufacture of a pharmaceutical product and, when used in a pharmaceutical product, becomes an active ingredient in a pharmaceutical product. This substance has pharmacological activity or other direct effects in the diagnosis, symptom relief, treatment or prevention of diseases, or can affect the function and structure of the body.
From the definition, it can be seen that intermediates are the key products of the previous process of making APIs, which are different from the structure of APIs. In addition, there are detection methods for APIs in the pharmacopoeia, but there are no intermediates.
Speaking of certification, the current FDA requires that intermediates must be registered, while COS does not, but there must be a detailed process description of the intermediates in the CTD file. In China, there is no mandatory GMP requirement for intermediates.
Preparation: In order to meet the needs of ** or prevention, it is made according to the requirements of a certain dosage form, and can be finally provided to the drug object. For example, the dosage forms of cefixime include cefixime tablets, cefixime capsules, and cefixime granules. All three dosage forms are formulations of cefixime.