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32 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m provide background knowledge and practical consider- ations that are useful to bio/pharmaceutica l manufac- turers' understanding of t he production, testing, and overall quality of their products. In the USP–NF, these informational chapters are numbered above <1000> and include <1079> "Good Storage and Distribution Practices for Drug Products," <1121> "Nomenclature" and <1226> "Verification of Compendial Procedures." The Ph. Eur., JP, and other pharmacopoeias similarly contain general chapters that are mandatory and enforceable, as well as chapters that are stated as being for information and non- mandatory. It is worth noting that Ph. Eur. Chapter 5.4 "Residual Solvents" represents the information contained separately in the International Council for Harmoniza- tion (ICH) Q3C guideline, a reminder of the important connection that may exist between regulatory guidance and pharmacopoeia requirements. This is also true for Ph. Eur. Chapter 5.20 "Elemental Impurities," USP <232> "Elemental Impurities–Limits," and the ICH Q3D Guide- line on Elemental Impurities, along with the associated removal of the compendial test for heavy metals from the pharmacopoeias, which further serves as an example of the significant challenges for the bio/pharmaceutical in- dustry to ensure compliance with updated regulatory and compendial requirements. General monographs typically provide overall quality requirements that are applicable to a specific dosage form or route of administration for drug products. In the Ph. Eur., there are general dosage form monographs for cap- sules, tablets, eye preparations, nasal preparations, paren- teral preparations and many others. In USP–NF, the gen- eral chapters numbered <1> through <5> serve the same function as the Ph. Eur. general monographs, and include quality requirements for injections, oral drug products, topical and transdermal products, mucosal products, and inhalation products. Specific monographs provide the minimum quality requirements that must be met for drug products and ingredients, and apply to all manufacturers of these materials. Specific monographs provide the minimum quality re- quirements that must be met for drug products and ingredi- ents, and apply to all manufacturers of these materials, both innovator and generic-drug companies. A monograph in- cludes the name of the ingredient or preparation; the defini- tion, packaging, storage, and labeling requirements; and the specification, consisting of a series of tests, procedures and acceptance criteria. In the USP–NF, there are currently more than 4900 specific monographs, and in Ph. Eur., there are more than 2400 monographs. These specific monographs cover the entire range of bio/pharmaceutical products, in- Early Development Commercialization Supply Nomenclature Excipient Monographs API Monographs Product Monographs General Chapters (e.g.): Water/Loss on Drying, Elemental Impurities, Residual Solvents, Chromatography, Dissolution, Dose Uniformity, Microbial Limits, Sterility Patent Expiration Entry Generic Marketing Exclusivity Regulatory Submission/Approval API Development Dosage Form Development Clinical Trials Figure 1. Impact of pharmacopoeia throughout drug product lifecycle. FIGURE COURTESY OF THE AUTHORS. Pharmacopoeia Compliance Series