Description
This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2The guidance applies to these product types throughout the lifecycle.
Regional GMPs apply to the manufacture of these products.
Stakeholders
6Entities intended to be alerted by this guidance.
Has ultimate responsibility to ensure an effective pharmaceutical quality system is in place.; Persons who direct and control a company or site at the highest levels.
Responsible for batch review and release
Party involved in outsourced activities
Party performing outsourced activities
Oversees reprocess or rework of batches
Regulatory Context
Regulatory Activities
3Used to evaluate the effectiveness of the pharmaceutical quality system.; Source of feedback on product quality and management review input
Direct access to source data and documents enabling inspections.
Sponsor's independent function to assess trial conduct
Document Types
4Document addressing the scope of the QMS and its procedures.
Describes the overall intentions and direction of the company related to quality.
Proposed changes evaluated relative to this filing
Required between contract giver and contract acceptor for outsourced activities
Attributes
3Drug product characteristics requiring bridging
Shelf life considerations if administration schedules are revised.
Used to monitor the effectiveness of processes and progress against quality objectives.
Technical Details
Substances
2Drug substances used to establish equivalence should be manufactured with materials manufactured at the new scale
The active ingredient in a drug product where NDSRIs could be present.
Testing Methods
2A technical activity within the Pharmaceutical Development stage.
Testing used to justify leveraging data across products
Processes
6Required when transferring a process to a new facility.
Mechanisms established through product and process understanding.
Accumulated knowledge used in assessing changes
General principles and practices for manufacturing validation; Summary of batch data for new synthetic procedures
Section P2 of the application information.
Managing the terminal stage of the product lifecycle
Standards & References
Specifications
2Planned set of controls derived from current product and process understanding
scientific understanding to support the establishment of the design space; multidimensional combination of input variables and process parameters
ICH References (4)
Pharmaceutical Quality System
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Reworking needs more evaluation and testing according to ICH Q7; Good manufacturing practice for API starting materials; Referenced regarding the definition of intermediates.
Principles of Quality by Design described within ICH Q8-Q11.; Pharmaceutical development guidance; Pharmaceutical development and CQA measurement during processing; Defines product lifecycle phases; Referenced for Critical Quality Attributes (CQA); Pharmaceutical Development.; General principles related to model development, validation and verification; Principles described in ICH Q8 apply to stability models; Pharmaceutical Development guideline mentioned regarding enhanced level of understandi
Quality Risk Management recommended for combination products
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