7/8 May 2024
The USP General Chapters—Packaging and Distribution Expert Committee proposes two new general chapters to address the qualification of polymeric components used in the manufacture of both pharmaceutical and biopharmaceutical active pharmaceutical ingredients (APIs) and drug products (DPs):
The drafts of these two chapters have been published for public comment in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Deadline for comments is July 31, 2017.
Background:
Chapter <665> was initially published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3> in PF 42(3) [May–June 2016]. The current proposals take into account comments received on the <661.3> proposal and from the USP Biocompatibility and Material Characterization Workshop held June 20–21, 2016. The chapter number <1665> was previously assigned to a proposed new general chapter Toxicological Safety Assessment of Extractables and Leachables (announced in the stimuli article "USP Plastic Packaging General Chapters: An Overview" in PF 39(6)). However, chapter number <1665> is now assigned to the proposed new general chapter Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.
Chapter <665> is structured as follows:
1. INTRODUCTION
2. SCOPE
3. ASSESSMENT PROCESS
3.1 Initial Assessment:
3.2 Risk Assessment:
4. POLYMERIC MATERIALS OF CONSTRUCTION
4.1 Plastic Materials Not Addressed in <661.1>
4.2 Cured Polymeric Materials
4.2.1 Test Methods
4.2.2 Specifications
5. POLYMERIC COMPONENTS AND SYSTEMS
5.1 Test Methods
5.2 Specifications:
Chapter <1665> discusses material characterization and selection and safety qualifications of polymeric components and systems used to manufacture drug products (previously proposed to be incorporated in general chapter <1661> to support the use and understanding of the new general chapter <661.3>). The chapter is structured as follows:
1. INTRODUCTION
2. SCOPE
3. GENERAL PRINCIPLES
3.1 Discussion
3.2 Material Characterization and Selection
3.3 Component Characterization and Selection
CHARACTERIZATION PROCESS
4.1 Initial Assessment
4.2 Risk Assessment
4.2.1 Risk evaluation matrix
4.2.2 Application of the risk evaluation matrix
4.2.3 Using the risk evaluation matrix
4.2.4 Linking risk to characterization methodologies
4.3 Establishing the Level of Characterization
4.3.1 Baseline assessment
4.3.2 Expanded baseline assessment
4.3.3 Full testing (extractables profiling)
4.4 Standard Extraction Protocol
4.4.1 Extraction solvents
4.4.2 Extraction temperature
4.4.3 Extraction duration
4.4.4 Accomplishing the extraction
4.4.5 Non-standard extractions
4.4.6 Accounting for conditioning and related steps employed in manufacturing
4.5 Testing the Extracts and Generating the Extractables Profile
4.6 Evaluation of the Extractables Profile Established by Implementing the Standard Extraction Protocol
5. SAFETY QUALIFICATION
5.1 General
5.2 Chemical Safety Qualification
5.3 Additional Safety Qualification
GLOSSARY
Following your registration on the Pharmacopeial Forum website you get access to the complete drafts of general chapters <665> and <1665>.