“Charge-in” of components as part of the production and process control during drug manufacturing consists of activities to confirm that the products produced do indeed have the identity, strength, quality, and purity as represented.
Section 211.101 outlines the FDA’s regulations related to charge-in of components in the following areas:
- Preserving the active ingredient
- Removal of components from the original container
- Supervision and secondary examination
- Verifying the batch
We’ll take a closer look at each of these in detail.
Let’s start by talking about preserving the active ingredient of the drug.
Preserving the Active Ingredient
Section 211.101 states that:
Written production and control procedures shall include the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:
(a) The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient.Specific procedures are required during manufacturing in order to ensure that no less than 100 percent of the active ingredient is provided.