What is a Finished Dosage Form?

A Finished Dosage Form (FDF) refers to the final form of a pharmaceutical product that is ready for administration to a patient without the need for any further modification. This term encompasses a wide variety of drug delivery systems, including tablets, capsules, injections, creams, ointments, and more. The development of FDFs is a critical phase in the pharmaceutical manufacturing process, involving the combination of active pharmaceutical ingredients (APIs) with excipients to create a product that is safe, effective, and convenient for patient use.

What information is required in order to obtain regulatory approval?

FDFs are the end-point of pharmaceutical development processes, bringing together science, technology, and regulatory standards to meet the therapeutic needs of patients. By transforming raw chemical compounds into user-friendly forms, FDFs make it possible for patients to accurately dose and safely consume medications. This transformation is essential for the efficacy of the treatment, as it ensures the active ingredient is delivered to the appropriate site of action within the body in the correct dosage and at the right time. Obtaining regulatory approval for an FDF requires several key pieces of information and documentation.

Depending on the region/country where approval is sought, the information & documentation requirements may vary since different regulatory agencies have their own set of guidelines and processes. However, some common data that is required includes:

Product information: details about the FDF like its composition, intended use, dosage strength, dosage form, packaging information & proposed shelf life.

Quality control data: data related to the quality of the product i.e., manufacturing processes, specifications for raw materials & finished products, stability data, analytical methods used for testing, and batch records.

Non-clinical data: pre-clinical studies conducted for assessing safety & efficacy i.e., pharmacology, toxicology, and other relevant studies.

Clinical data: for products intended for human use, clinical data from control trials are required to support the product’s safety and efficacy in humans.

Regulatory documentation: application forms, labelling information, summary of product characteristics (SmPC), and other documents required by regulatory agency.

GMP compliance: evidence of compliance with GMP standards for ensuring quality, safety, and consistency.

Risk management: documents related to risk assessment and risk management plans particularly for those products that demonstrate potential safety concerns or have special handling requirements.