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...