Description
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)August 2001ICH
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Stakeholders
1Oversees reprocess or rework of batches
Regulatory Context
Regulatory Activities
1The regulatory activity where inclusion of specific populations is discussed; The primary vehicle for generating robust clinical data for these populations.; Trials including pregnant participants for non-obstetric or obstetric indications; Inclusion of breastfeeding women in clinical trials; Research studies where breastfeeding women may be included.; The context in which these outcome parameters are collected.
Document Types
3Document indicating analytical results of testing; record relied on to control L. monocytogenes in ingredients; document provided for a food prior to or upon receipt of the food; COA documentation
Records documenting the production of a specific batch; Records prepared for each intermediate and API batch; Recording disposition of each batch and in-process test results; Records used to document packaging and labeling operations; Documentation for production of APIs for use in clinical trials
Documents describing the manufacturing process for a batch; Approved by the quality unit to ensure quality; Instructions prepared to ensure uniformity from batch to batch; Specifies time limits for production steps
Attributes
1levels of existing and new impurities; Characteristic of drug substance that may change with starting material redesignation; A comparison of the impurity profile of pre- and post-modification material to establish equivalence; Evaluation of the impurity profile for intermediates or drug substance; Potential to adversely affect drug substance quality; A description of the identified and unidentified impurities present in a drug substance.; The description of identified and unidentified impuritie
Technical Details
Substances
1Subject of WHO stability testing guidelines.
Testing Methods
1On-going testing program to confirm storage conditions and retest dates
Processes
3implied manufacturing process under QS regulation
Production method requiring additional information in a notification; Manufacturing process using microorganisms like bacteria or yeast.; Changing conditions to alter the chemical or molecular composition.; ingredients produced using fermentation; information about the organism and fermentation process; relevant to safety and identity of microorganisms; NDI produced by fermentation using microorganisms
Specific guidance for APIs manufactured by cell culture/fermentation.
Standards & References
Specifications
1limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests
ICH References (3)
Recommendations for cell bank stability
Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Appropriate GMPs as defined in ICH Q7A
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2