[COLOR=“#000000”]“This section contains proposals for adoption as official USP or NF standards (either proposed new standards or proposed revisions of current USP or NF standards). These may be any of the following: (1) proposed revisions placed directly under In-Process Revision, or (2) modifications of revisions previously proposed under In-Process Revision. Readers should review material in this section and provide comments to the Scientific Liaison using the contact information appearing at the end of each proposal. Information on how to comment can be found under the “Participation” section of
. It is important to send comments promptly, using the comment deadline listed after each title”
- PROPOSITIONS DE REVISION DE CHAPITRES GENERAUX (Selection)
- 39(4) In-Process Revision: <111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS
- 39(4) In-Process Revision: <659> PACKAGING AND STORAGE REQUIREMENTS
- 39(4) In-Process Revision: <1115> BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS
- 39(4) In-Process Revision: <1229.6> LIQUID-PHASE STERILIZATION
- 39(4) In-Process Revision: <1234> VACCINES FOR HUMAN USE-POLYSACCHARIDE AND GLYCOCONJUGATE VACCINES
- 39(4) In-Process Revision: <1240> VIRUS TESTING OF HUMAN PLASMA FOR FURTHER MANUFACTURE
- BRIEFINGS DE CETTE SELECTION DE CHAPITRES
<111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS. USP 36 page 108. USP has developed four general information chapters pertinent to bioassays: <1030>, <1032>, <1033>, and <1034>. The latter three became official August 1, 2012, and <1030> will become official December 1, 2013. These new chapters largely replace the current general chapter <111>. It is now proposed to replace the current <111> with a completely revised <111> that covers a much reduced set of topics appropriate for a chapter numbered below 1000. This revision, if approved, will not become official until citations to the current <111> from monographs and other chapters are updated. To simplify revision of existing documents, the chapter title and titles of retained sections have been kept as they appear in the current <111>. (STAT: M. Kibbey.)
<659> Packaging and Storage Requirements. USP 36 page 280 and PF 38(6) [Nov.–Dec. 2012]. In response to patient safety concerns with the use of single-dose containers, two Expert Committees—the Compounding Expert Committee and the Nomenclature, Safety, and Labeling Expert Committee— in conjunction with the FDA and CDC are proposing a revision to the single-dose container definition to emphasize that it is intended for one- time use in a single patient.
<1115> Bioburden Control of Nonsterile Drug Substances and Products. In terms of microbiological contamination risk control, there are two broad categories of drug products: a) sterile products and b) nonsterile products.
Microbial content in nonsterile products is controlled to a level consistent with patient safety. Use of excessive controls that would add complexity or cost without a commensurate safety benefit is not advantageous in terms of added value to either the patient or the manufacturer. Therefore, a pragmatic scientific approach to management of the microbial bioburden in nonsterile products requires consideration of patient risk and contamination control objectives to achieve a practical and appropriate level of risk management.
This chapter outlines a risk-based approach to the control of potential contamination in nonsterile product manufacturing. It provides information about microbial control considerations in product development, microbial control considerations in routine manufacturing, microbial control of drug substance manufacturing, equipment design and use considerations, personnel, the manufacturing environment, microbial assessment of nonsterile product manufacturing environments, active measures for microbial control, and overall management of a microbiological control program. (GCM: R. Tirumalai.)
<1229.6> Liquid-Phase Sterilization. The USP General Chapters—Microbiology Expert Committee is dividing the current general chapter Sterilization and Sterility Assurance of Compendial Articles 1211 into twelve separate chapters [see Pharmacopeial Forum 38(2)]. Four of these twelve chapters (<1229>, <1229.1>, <1229.2> and <1229.3> will be official in the Second Supplement to USP 36 (August 2013). The remaining eight are in progress, with plans to have five of them (<1229.4>, <1229.7>, <1229.8>, <1229.10>, and <1229.6>) appear in the Pharmacopeial Forum in 2013.
Chapter <1229.6>, which provides an overview of liquid-phase sterilization and its validation using either the half-cycle or bracketing methods, is proposed in this PF.
<1234> Vaccines for Human Use—Polysaccharide and Glycoconjugate Vaccines. This new general information chapter continues the vaccine chapter series begun by Vaccines for Human Use <1235> and Vaccines for Human Use—Bacterial Vaccines <1238>. This chapter builds on the predecessor chapters by describing best practices for production, conjugation, and characterization of this often complex class of vaccines. It describes key quality attributes at each step of the process and suggests best methods to assess these attributes.
<1240> Virus Testing of Human Plasma for Further Manufacture. Human-plasma-derived products are manufactured from donated human plasma and include many therapeutically important medicines. The scope of this new general information chapter is virus testing performed on human plasma for further manufacture of pharmaceuticals. The chapter also contains an Appendix with regulatory guidances and references that support the recommendations. [/color]