Issue link: https://www.e-digitaleditions.com/i/1302985
32 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Therefore, before proceeding with deriving a working analytical procedure from a monograph and a general chapter, it is important to under- stand the requirements of the General Notices. The General Notices cover definitions of the sub- ambient temperature range, defining "about" when weighing a substance, rounding rules of analysis results before comparison with the specification, and many others. Criteria in the General Notices are requirements unless stated in either a mono- graph or a general chapter. Monographs take pre- cedence over general chapters. Mandatory and informational general chapters. Ana- lytical techniques used for analysis of APIs, excipi- ents, and finished products are documented in the general chapters of the USP, and these are divided into the following two types, dependent on the numbering of an individual general chapter: • General chapters numbered below 1000 are mandatory and apply to the analysis of a sub- stance in a monograph except when the re- quirements of a monograph differ from the requirements specified in these General Notices or an applicable general chapter. In these cases, the monograph requirements apply and super- sede the requirements of the General Notices or applicable general chapters, whether or not the monograph explicitly states the difference. • General chapters numbered 1000 to 1999 are for informational purposes only. They contain no mandatory tests, assays, or other requirements ap- plicable to any official article, regardless of citation in a general chapter numbered below 1000, a monograph, or the General Notices. In recent revisions of general chapters, the aim of the USP has been to issue pairs for the same analytical technique (e.g., the mandatory Ultravi- olet-Visible Spectroscopy <857> has a companion Data Integrity Revised fig 1 (colors added and some other changes) Revised fig 3 (only change is in bottom line text) United States Pharmacopoeia (USP) General Notices Monograph General Chapters < 1000 General Chapters >1000 Procedure implementation in an individual laboratory • USP <1058> Analytical Instrument Qualification • USP <1029> Good Documentation Practice Analytical Procedure for each Test • Reference Standards USP <11> • Reagents • Legal requirement • Tests for any sample taken over life (not batch) • Mandatory unless defined in Monograph or General Chapter • Mandatory • Key parameters and acceptance criteria • Informational (strong guidance) • Best practice approaches Classical Methods Observation Classical Methods Paper Records Classical Methods Some hybrid records but primarily paper Instrumental Methods Hybrid: electronic records with printouts Instrumental Methods E- working enforced by technical controls Spectrum of Pharmacopoeial Test Methods Greater data integrity risk through lack of objective evidence Procedural control can be inconsistent Technical controls lower data integrity risk Consistent operation Colour Odour Appearance Titration Analytical Balances pH Meters Loss on Drying Chrom Data Systems UV, IR systems Chrom Data Systems LIMS, ELN or LES interfaced to instruments Figure 1. Basic structure of the United States Pharmacopeia and relationships between the different sections. FIGURES ARE COURTESY OF THE AUTHORS.