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The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

(FDA 21 CFR 210.3)The development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

They provide the EEA's harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.

If a question is not addressed, marketing-authorisation holders are encouraged to contact the European Medicines Agency for further information at [email protected]

The product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). The degree of closeness of the determined value to the nominal or known true value under prescribed conditions. The accuracy of an analytical method is the closeness of test results obtained by that method to the true value.

(FDA 21 CFR 210.3)The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. Accuracy can often be expressed as percent recovery by the assay of known, added amounts of analyte.

In addition, it is not clear to which extent such different appearances would have an effect on patient / user acceptability.

Moreover, the introduction to the variation classification guidelines (2013/C 223/01) includes the following statement: "References in this Annex to changes to the marketing authorisation dossier mean addition, replacement or deletion, unless specifically indicated." For the purpose of illustration and comparison, change code B.

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Acceptance of such different tablet appearances in the specification of a single strengthproduct would formally also allow the company to dispense these two appearances in the same container/blister, which may even cause greater confusion.This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.Active Pharmaceutical Ingredients (API) and intermediates for pharmaceutical use (i.e.Although the definition of active ingredients in Division 2, Part C of the includes APIs and bulk process intermediates (BPI), the present GUI-0104 only applies to APIs.Guidance on the fabrication, packaging/labelling, testing, distribution, wholesaling, and importation of drugs in dosage form, and BPIs for radiopharmaceutical and biological drugs is provided in the can be considered with the appropriate scientific justification.

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