Description
This guidance document provides guidance on general principles for the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
5Example of a control strategy summary for biological drug substances
Requires analytical comparability per ICH Q5E
Covered by GFI #99
RTRT and CTD sections apply to drug substances
RTRT and CTD sections apply to drug products
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
4Submissions for product approval.; Submission of raw data supporting study endpoints; Additional Data Files for Marketing Applications for MDS Drugs
Specifications are approved by regulatory authorities
Risks relating to products that have a marketing authorization
Submission of PBRERs when reporting intervals differ
Document Types
3Section III.A of the guidance.
Submissions standardized by ICH guidelines
List of tests and acceptance criteria for the drug product; Tests and acceptance criteria considered applicable to all drug products
Attributes
7Factor for consideration in analytical assessment.
Physicochemical property determined by isoelectric focusing
Molar absorptivity determined at specific wavelengths
specifications for the purity, strength, and composition of dietary supplements
Term used for materials instead of potency.
Measurement of potency for biological products
Variations in patient preferences even within the same disease state
Technical Details
Substances
10Products composed of well-characterized proteins
Carbohydrate content and structure analysis
Component used in human and animal drugs
Components necessary to manufacture a device
Differences in excipients may affect product stability
Finished dosage form undergoing stability testing
Postapproval changes to drug substances; the active pharmaceutical ingredient being modified; Evaluation of physical properties for drug substance; Active ingredient intended to furnish pharmacological activity; The molecule or ion responsible for the physiological or pharmacological action.; The active pharmaceutical ingredient subject to postapproval changes
Products composed of well-characterized polypeptides
Well-qualified material used as a calibration point in comparability exercises.
Process-related impurity arising from cell substrates
Testing Methods
10Used to examine samples for physical, chemical or biological changes
Used for correlations between factor activity and antigen levels
Used for analysis of characteristic structures like uronic acid
Used to examine higher-order structure
Used in series with mass spectrometry
Used to determine extinction coefficient
Used for determining isoform pattern
Specific electrophoresis method in the Japanese Pharmacopoeia.
Used to characterize molecular weight distribution
Complementary analytical technique
Processes
8Procedures employing monoclonal antibodies for purification
Used to demonstrate removal of cell substrate-derived impurities
Physical modification that does not result in chemical alteration.; A process that does not typically chemically alter an ingredient
Determination of the properties of a cell substrate or cell bank.
Primary process described in the guideline; Core activity described in the guidance; General process for evaluating product quality over time; Formal stability studies to assess adjuvant stability; Evaluation of attributes at all storage conditions; The process of evaluating product quality over time under specified conditions.; Evaluation of product quality over time
Biosynthetic process producing glycoforms
Source of impurities such as processing reagents or column leachables.
Changes to this process may affect the identity and NDI status of an ingredient.; Changes to this process may create an NDI; you should describe the manufacturing process and provide detailed information; includes fermentation as an intrinsic part of identity
Identified Hazards
Hazards
5identity and level of any impurities and contaminants
Viruses introduced during production; Contamination risk in production batches
Molecular variants of the desired product formed during manufacture or storage; Molecular variants of the desired product including degradation products
Measurement of stereoisomers as impurities
Transmission of adventitious agents is a key issue in human- and animal-derived materials.; Human- and animal-derived materials increase the risk of introducing adventitious agents
Standards & References
External Standards
2recognized standard reference for analytical methods
Basis for inorganic impurity acceptance criteria.
Specifications
4limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests
Limits applied throughout the storage period of the product
Limits applied at the time of batch release
Limits for total microbial counts and endotoxins
ICH References (6)
Specifications for biotechnological/biological products; Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Recommendations for cell bank stability
Text on Validation of Analytical Procedures
Validation of Analytical Procedures: Methodology
Quality of Biotechnological Products: Stability Testing
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- E11A Pediatric Extrapolation
- M15 General Principles for Model-Informed Drug Development
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Rare Diseases: Considerations for the Development of Drugs and Biological Products
- Q3C Impurities: Residual Solvents_2011
- Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry
- Q4B Annex 5: Disintegration Test General Chapter