Description
The following document is a revised version of VICH GL3 and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the three regions of the European Union (EU), Japan, and the United States.
Scope & Applicability
Product Classes
6Subject of stability testing guidance
Medicinal products often packaged in LDPE pouches
A pharmaceutical product type containing a new or existing drug substance
Designated therapeutic moiety not previously registered
Subject of stability testing guidance
Includes pharmaceuticals, biologics, vaccines, cell or gene therapy products
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
10Long-term, accelerated, and intermediate conditions
Acceptable variations in temperature and relative humidity
Property of a device that may be changed via established protocols
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Derived from climatic data to define testing conditions; Single derived temperature affording the same thermal challenge as a range of temperatures
The period of time during which the drug substance is expected to remain within its specification; Derived from stability information for drug substances
Defined as failure to meet specification for a drug substance
40°C ± 2°C / 75% RH ± 5% RH
30°C ± 2°C / 65% RH ± 5% RH
25°C ± 2°C / 60% RH or 30°C ± 2°C / 65% RH
Related CFR Sections (2)
- 21CFR211.137§ 211.137 Expiration dating.
(a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166 .Read full regulation →
- 21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers Read full regulation →
See Also (8)
- CPG Sec. 480.100 Requirements for Expiration Dating and Stability Testing (Status: Final)
- CPG Sec. 480.300 Lack of Expiration Date of Stability Data (Status: Final)
- Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry (Status: Final)
- CVM GFI #5 Drug Stability Guidelines (Status: Final)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry (Status: Final)