Pharmaceutical Development Report also known as a Product Development Report (PDR) in pharmaceutical industry is one of the significant sections of the Common Technical Document (CTD) for regulatory submission.
The ICH guideline Q8 (R2) on Pharmaceutical Development provides a guidance for the PDR preparation with a comprehensive understanding of the product and manufacturing process and create a basis for flexible regulatory approaches.
A complete PDR provides a comprehensive understanding on the development studies conducted to establish that the dosage form, formulation, manufacturing process, container closure system, microbiological attributes and usage instructions are appropriate for the purpose specified in the application.
Table of Contents of Pharmaceutical Development Report
1. Introduction
1.1 Objective
1.2 Scope
2. Pharmaceutical Development
2.1 Reference product characterization
2.2 Components of drug product
2.2.1 Drug substance (API characteristics: Solubility, Water content, Particle size, Crystal properties, Biological activity, Permeability, Melting range etc.)
2.2.2 Excipients (The characteristics of excipients that can influence the performance of the pharmaceutical product or its manufacturing capability should usually be discussed relative to the respective function.)
2.3 Drug product
2.3.1 Formulation development (A summary of formulations used in stability study, bioavailability or bioequivalence studies should be provided.)
2.3.2 Overages (to compensate for loss during manufacturing or any other reasons that are scientifically justified)
2.3.3 Physicochemical and biological properties (Parameters relevant to the performance of the drug product: hardness, thickness, friability, flow property, pH, disintegration time, dissolution, impurities, assay etc.)
2.4 Manufacturing process development (to consider the critical formulation attributes, together with the available manufacturing process options)
2.5 Container closure system (Justification of choice of container closure system to ensure the protection from moisture and light, compatibility of the materials of construction with the dosage form and safety of materials of construction.)
2.6 Microbiological attributes (to justify the efficacy and safety of antimicrobial preservative)
2.7 Compatibility (to ensure the drug substance is compatible with excipients, even extremes of concentration)
2.8 Stability (6M stable at accelerated condition, or others justified condition)
Major Elements of Pharmaceutical Development Report
- Quality target product profile (relates to quality, safety and efficacy)
- Critical quality attributes (physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit)
- Risk assessment: linking material attributes and process parameters to drug product CQAs (should review the materials, process, equipment, storage, distribution and intended use of the product)
- Design space (justification and description of multi-dimensional space that assure quality)
- Control strategy (to ensure that a product of required quality will be produced consistently)
Additionally, should identify and describe any formulation and process attributes that may influence batch reproducibility, product performance and drug product quality. Supportive data and results from specific studies or published literature can be included within or attached to the Pharmaceutical Development report. Additional supportive data can be referenced to the relevant nonclinical or clinical sections of the application.
){kind=link}
Any SOP for preparation of PDR
ReplyDelete