Description
Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.
Scope & Applicability
Product Classes
1Firms implementing ICH guidances
Stakeholders
5Entities providing raw materials and ingredients
personnel who must receive training on Listeria control
Regulatory official who may review the Food Defense Plan.
Regulatory official reviewing application data
Internal department involved in sourcing and sharing information
Regulatory Context
Attributes
4Physical, chemical, biological, or microbiological properties
Risk factor to be assessed during manufacturing changes
A functional role of sodium in food
identify any critical process parameters that should be monitored or controlled
Related CFR Sections (2)
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR211.165§ 211.165 Testing and release for distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on sRead full regulation →
Related Warning Letters (10)
- 2024-11-26
CGMP/Finished Pharmaceuticals/Adulterated
Catwalk Cosmetic Laboratories Pty Ltd.
- 2024-11-26
CGMP/Finished Pharmaceuticals/Adulterated
Hangzhou Huiji Biotechnology Co., Ltd.
- 2024-10-29
CGMP/Finished Pharmaceuticals/Adulterated
MedOffice Saglik Endustri Anonim Sirketi
- 2023-02-07
CGMP/Finished Pharmaceuticals/Adulterated
Salon Technologies International, Inc.
- 2023-01-31
CGMP/Drug Products/Adulterated
Urban Electric Power
- 2023-01-31
CGMP/Drug Products/Adulterated
Mohawk Laboratories Division of NCH Corporation
- 2022-05-10
CGMP/Finished Pharmaceutical/Adulterated
David Cosmetic Co., Ltd.
- 2022-04-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
- 2021-11-09
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Bionateo Sp. z.o.o.
- 2021-11-02
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
DongBang Cosmetics Co., Ltd.
See Also (8)
- FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
- Analytical Procedures and Methods Validation for Drugs and Biologics (Status: Final)
- ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry (Status: Final)
- Botanical Drug Development: Guidance for Industry (Status: Final)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry (Status: Draft)
- Advanced Manufacturing Technologies Designation Program (Status: Final)
- Considerations for Complying with 21 CFR 211.110 (Status: Draft)