FINAL L 6 - Quality and the FDA Flashcards
ICH Q10 Objectives
-Achieve product realization
-Establish and maintain a state of control
-Facilitate continuous improvement
IND
-Typical Drug substance specifications
-Typical Drug product specifications
Common Technical Document
(Slide 32): Module 2, Module 3, Module 4, and Module 5
Module 2:
-Quality/overall summary
-Nonclinical overview
-Nonclinical summaries
-Clinical overview
-Clinical summary
Module 3:
Quality 3.0
Module 4:
-Nonclinical study
-Reports 4.0
Module 5:
-Clinical study
Reports 5.0
FDA Mission:
Protect the health and safety of consumers by ensuing that drug, biological and medical device products are SAFE and EFFECTIVE and by ensuring that products such as FOOD and COSMETICS are safe and are made under sanitary conditions. Also, to ensure that all product packaging and labeling is truthful, informative and not deceptive
Components of an NDA pt.1:
- Tablet of contents
- Summary
- Evaluation of safety and effectiveness
- Copies of the label and all other labeling to be used for the drug
- A statement as to whether the drug is (or is not) limited in its labeling and by this application to use under the professional supervision of a practitioner licensed by law to administer it
Components of an NDA pt. 2
- A full list of the articles used as components of the drug
- A full statement of the composition of the drug
- A full description of the methods used in, and the facilities and controls used for the manufacture, processing and packing of the drug
- Samples of the drug and articles used as components
- List of investigators
Components of an NDA -3
- Full reports of preclinical investigations that have been made to show whether or not the drug is safe for use and effective in use
- Full reports of clinical investigations that have been made to show whether or not the drug is safe for use and effective in use
- If this is a supplemental application, full information on each proposed change concerning any statement made in the approved application
ANDAs
-Provide for review and approval of generic product (pharm. equivalence; sameness)
-Generic drug product comparable to innovator in:
-Quality
-Performance characteristics
-Intended Use
-Called abbreviated because:
-Do not include preclinical and clinical data
-Instead generic applicants must scientifically demonstrate bioequivalence
-24-36 healthy human volunteers
Six Systems:
-Production
-Facilities and Equipment
-Laboratory Controls
-Materials
-Packaging and Labeling
-QUALITY SYSTEM
Impurity definitions:
Any component of a drug substance that is NOT the chemical entity defined as the drug substance
-Unwanted coexisting components in bulk pharmaceutical chemicals that arise during manufacture and/or subsequent storage
impurity profile:
Description of the identified and unidentified impurities present in a new drug substance
-Monitored on an ongoing basis through stability studies
