Quality Attributes Quality Parameters

1
Quality AttributesQuality Parameters

• Blair A. Fraser
• Office of New Drug Chemistry
• Office of Pharmaceutical Sciences
• Center for Drug Evaluation and Research

2
Specification

• Specification as used in 21CFR601.12 of this
  chapter means the quality standard (i.e., tests,
  analytical procedures, and acceptance criteria)
  provided in an approved application to confirm
  the quality of products drug substances, drug
  products, intermediates, raw materials, reagents,
  components, in-process materials, container
  closure systems, and other materials used in the
  production of a drug substance or drug product.
• 21CFR314.50 Federal Register 6918728, April 8,
  2004.

3
Quality Attribute

• A molecular or product characteristic that is
  selected for its ability to help indicate the
  quality of the product. Collectively, the
  quality attributes define the adventitious agent
  safety, purity, potency, identity, and stability
  of the product. Specifications measure a selected
  subset of the quality attributes.
• ICH Q5E

4
Biotechnology Product Quality Attributes

• Structure of Protein
• Covalent attributes
• Conformational attributes
• Function of Protein
• Intrinsic
• Extrinsic
• Purity of Protein
• Beginning as an active pharmaceutical ingredient
• Preserving the balance
• Arriving at the destination
• Stability of Protein
• Intermediates
• In-process materials
• Drug Substance
• Drug Product

5
Process Analytical Technology

• Process Analytical Technology is
• a system for designing, analyzing, and
  controlling manufacturing through timely
  measurements (i.e., during processing) of
  critical quality and performance attributes of
  raw and in-process materials and processes with
  the goal of ensuring final product quality.  
• It is important to note that the term analytical
  in PAT is viewed broadly to include chemical,
  physical, microbiological, mathematical, and risk
  analysis conducted in an integrated manner.
• http//www.fda.gov/cder/OPS/PAT.htm
• Process understanding, a quality parameter

6
Quality and Specifications

• Support the label claim
• Structure
• Function
• Dosage Form Content
• Stability
• Specifications
• Quality attributes
• Compendial requirements
• Global requirements
• Appropriate specifications, a review issue