FDA--Food and Drug Administration CFR--Code of Federal Regulations This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) Subpart A--General Provisions Sec. 11.1 Scope. (a) The regulations in this part s...

STABILITY TESTING: PHOTOSTABILITY TESTING OF NEW PHARMACEUTICAL SUBSTANCES AND PRODUCTS 1. GENERAL The ICH Harmonized Tripartite Guideline covering the Stability Testing of New Pharmaceutical Substances and Products (hereafter referred to as the Parent Guideline) notes that light testing should be an integral part of stress testing. This document is an annex to the Parent Guide...

A Journey of Labonce Stability test Chamber China’s stability chamber have traveled across the oceans, Settled in Frankfurt. Today we are going to say a story of a stability chamber spans more than eight thousand kilometers, traveled across the oceans, finally settled in Frankfurt. On November 7th, CPHI Worldwide Europe has successfully concluded. Since then, The first trip of Labonce to the exhib...

The equipment numbering system for drug stability test chambers uses a combination of letters and numbers to intuitively reflect the functional characteristics, compliance standards, and volume parameters of the equipment. The following is a detailed analysis of the numbering rules: 1. Basic Function Identification 1) LGS: Low humidity, GMP, Stability chamber (GMP stability chamber with low humidi...