Usp 382

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Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.

Stoppers

Key elements of these changes are:

  • The prior <381> (Elastomeric Closure for Injections, Heavy Metals and Extractable Zinc) heavy metals tests section was removed.
  • The heavy metals tests from section of <381> (Elastomeric Closure for Injections, Heavy Metals), have been removed and in <1381> controlled extraction studies as described in USP <1663> are recommended.
  • The most significant change in new <381> (Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems) is that elastomeric component combination product developers now are responsible for evaluating extractable testing needs, including justifications.
  • The new <381> functionality tests section will be omitted after 5 years (2025), allowing industry-wide implementation of <382> (Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems).
  • <382> includes fitness-for-intended-use elastomer functionality requirements for vial and bottle systems, pre-filled and single-use syringe systems, blow-fill sealed containers, dental cartridges, pen injectors, and plastic containers for IVs.
  • <1382> (Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems) includes guidance for test sample preparation, test population, test procedures, ISO standards references, data interpretation, and reporting.

As a result, West is making changes to related quality certificates, which currently provide results for USP/EP combined chemical testing. As heavy metals and zinc belong to chemical testing, the reference to USP will be removed; testing will continue following EP 3.2.9 (Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders). <381> heavy metals and zinc update will be effective 01-Dec-2020; functional testing will continue harmonization with EP 3.2.9 until the 2025 expiration.

Diane and Dan's OnDemand Webinar on USP Elastomer Chapter Revisions

Specific West components will be evaluated to demonstrate USP <382> compliance. Additionally, West will offer product packaging and delivery systems contract testing services for <382> compliance and <1382> compatibility through its Integrated Solutions platform. For more information, watch West's On-Demand webinar.

Sours: https://www.westpharma.com/en/blog/2020/November/new-usp-chapters

USP Cancels Revisions to Packaging Chapters

In an online posting on Feb. 23. 2018, USP announced the cancellation of revisions to packaging-related general chapters pending “comprehensive and strategic redevelopment” following comments received on the proposed revisions.

The affected chapters, which were published for comment in Pharmacopeial Forum 43(3) [May–Jun. 2017], are as follows: 

  • <660> Containers-Glass
  • <1660> Evaluation of the Inner Surface Durability of Glass Containers
  • <381> Elastomeric Closure for Injections
  • <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems
  • <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems
  • <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery 

USP noted that the revisions will appear on the Cancellations list for the Second Supplement to USP 41–NF 36, which will be posted on April 27, 2018. USP anticipates that it will publish revised proposals for the affected General Chapters in a future issue of the Pharmacopeial Forum.

Source: USP

Sours: https://www.pharmtech.com/view/usp-cancels-revisions-packaging-chapters-0
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As previously reported in "USP´s Intent to Revise and to Develop Elastomeric Packaging Chapters" the U.S. Pharmacopeial Convention (USP) proposes to revise and to develop the following general chapters:

  • <381> Elastomeric Closures for Injections (revision, proposed new title: Elastomeric Components used in Injectable Pharmaceutical Packaging/Delivery Systems), 
  • <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (new),
  • <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems (new), and
  • <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (new).

The drafts of these four chapters have now been published for public comment in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Deadline for comments is July 31, 2017.

Together with the above mentioned proposed change of the title, the USP Packaging and Distribution Expert Committee is proposing the following revisions which will update and expand the scope of the current chapter <381>:

  • Emphasize the baseline requirements for the selection of thermoset and thermoplastic elastomeric components;
  • Expand the scope to include all elastomeric components used in an injection packaging system. Elastomeric components include, but are not limited to, those used for vials, bottles, prefilled syringes (plungers, needle shields, and tip caps), cartridges (plungers and seal liners), injection ports for flexible bags and infusion sets, and plungers for single-use syringes;
  • Delete the Heavy Metals <231> testing and add a modern method for extractable element determination;
  • Omit functionality tests and assessment from the chapter and move them to the two proposed new chapters: 

    A)Functionality tests appear inElastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems <382>.   The proposed new general chapter will address the fitness-for-intended-use functionality requirements of elastomeric packaging/delivery systems that are intended for injectable dosage forms. When properly fitted with dimensionally compatible packaging/delivery systems, the closures are intended to protect and contain the drug product while enabling safe and effective in-use product access. The function being performed by any single elastomeric closure type is dependent on the packaging/delivery system and may cover more than one functional parameter.

    B)Baseline information for the assessment is provided inAssessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems <1382> to assist users in the functionality assessment of elastomeric closures as part of packaging/delivery systems intended for injectable dosage forms. Proper selection and design of functionality assessment studies is based on sound scientific principles that are consistent with
             - the nature of the packaging system and packaged drug product; 
             - the clinical use of the packaged drug product; and
             - the perceived safety risk associated with the packaging system and drug product.

    According to the proposal, alternative testing strategies for functionality assessment may be appropriate in certain circumstances with proper justification. In chapter <1382>, a more complete discussion of fitness-for-intended-use testing, as compared to closure functionality assessment in early package development, is presented including guidance on test samples and their preparation, test sample population size, test procedures, test acceptance criteria (data interpretation), and test outcome reporting.
  • Develop an additional informational chapter, Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems <1381>, to support the current chapter revision by:
    - Describing elastomeric components and their materials of construction for use in pharmaceutical packaging systems,
    - Providing a high-level introduction to elastomer chemistry, manufacturing technology, and the post processing of components,
    - Explaining basic functional characteristics of components,
    - Designating baseline requirements, 
    - Discussing identification testing. 

Additionally, minor editorial changes have been made to update the chapter to current USP style.

Furthermore, a workshop, Modernization of USP Packaging Standards for Glass and Elastomeric Components, will take place June 19–20, 2017 at the USP Meetings Center in Rockville, Maryland, to discuss these four proposals.

USP also provided a briefing list in PF 43(3) which includes monographs and/or chapters that both reference the general chapter <381> under revision and require revision to keep references to the General Chapter accurate. USP says that "other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles".

Following your registration on the Pharmacopeial Forum website you get access to the complete drafts of general chapters <381>, <382>, <1381> and <1382>. 

Sours: https://www.gmp-compliance.org/
USP 382

The USP wants to revise the general chapters on elastomeric components. The Notice of Intent to Revise has been posted on May 31, 2019. The previous proposals that were published in PF 43(3) were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee (GC-PDEC) provides new proposals for:

  • <381> Elastomeric Closures for Injections (New proposed title: ELASTOMERIC COMPONENTS IN INJECTABLE PHARMACEUTICAL PRODUCT PACKAGING/DELIVERY SYSTEMS)
  • <382> Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems
  • <1381> Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems
  • <1382> Assessment of Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems

GC-PDEC proposals for new chapters

The GC-PDEC is proposing new versions of these chapters with the following key changes:

  • Emphasize baseline requirements on the selection of thermoset and thermoplastic elastomeric components in <381>.
  • Expand the scope of <381> to include all elastomeric components in injectable product packaging/delivery systems (e.g., components used in systems intended for transient product storage and/or delivery for specific pharmaceutical products, like co-packaged single-use syringes and infusion set components for specific products).
  • Delete Table 1 in <381>.
  • Delete the washing and boiling step prior to and include a temperature monitoring probe in the autoclave cycle for preparation of sample solution in 4.2 Physicochemical Tests of <381>.
  • Delete the Heavy Metals and Extractable Zinc tests in <381>. According to the proposal, it is left up to the component user to evaluate the need for performing extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished (an example of extractable elements testing strategy is provided in <1381>).
  • Include a new informational chapter <1381>, which is meant to support the current chapter <381> revision by:
    - Describing elastomeric components and their materials of construction,
    - Providing a high-level introduction to elastomer chemistry, manufacturing technology, and the post-processing of components,
    - Discussing identification testing,
    - Discussing extractable elements.

Timelines

According to the USP, the changes outlined above will become official via the usual implementation time frame (i.e. six months from publication in the USP). The new USP general chapters  <382> and <1382> address the fitness-for use functional suitability requirements of packaging / delivery systems that are intended for parenteral dosage forms and that include primary packaging components partially or completely made of elastomeric materials. Due to the scope of the proposed new chapter <382> and the industry impact, the GC-PDEC is proposing a 5-year delayed implementation to allow industry adequate time to implement <382>. Once <382> becomes fully implemented, the functionality test in <381> will be omitted.

USP Monographs and / or chapters with reference to general chapter <381>

USP Monographs and / or chapters that reference general chapter <381> and require revision to keep those references accurate are:

  • Parenterals - Product Quality Tests <1>,
  • Packaging and Storage Requirements <659>,
  • Ophthalmic Products - Quality Tests <771>,
  • Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants <1031>,
  • Quality Assurance in Pharmaceutical Compounding <1163>,
  • Package Integrity Testing in the Product Life Cycle - Test Method Selection and Validation <1207.1>,
  • Assessment of Extractables <1663>,
  • Assessment of Leachables <1664>,
  • Mandelic Acid monograph.

According to the USP, the proposed revisions will be published in Pharmacopeial Forum (PF) 45(4) [Jul.–Aug. 2019]. The objective of this pre-posting is to give stakeholders sufficient time to review the proposals and comment by September 30, 2019 (deadline). In the absence of any adverse comments the chapters are anticipated to be published in USP 43-NF 38, Second Supplement (the targeted official date is December 1, 2020).

Prior to the end of the comment period, the ECA will conduct a conference on "Plastic/Elastomeric Materials for Pharmaceutical Packaging and Production" with members of the USP GC-PDEC in Barcelona on 25/26 September 2019.

More information can be found in USP´s Revisions to Elastomeric Components for Injections Chapters <381>, <382>, <1381> and <1382> .

Sours: https://www.gmp-compliance.org/

382 usp

Webinar: USP Elastomer Chapter Revisions Will Become Official December 2020: What you Need to Know

The USP has initiated the modernization of the packaging chapters with intent to promote a risk-based approach for selecting and qualifying packaging components.  A notice of intent to revise the elastomer standards was published in the USP PF 45 (4) 2019 related to the following: 

  • <381> Elastomeric Closure for Injections
  • <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems
  • <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems
  • <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

The standards below 1000 will provide baseline specifications while chapters above 1000 will provide information to guide qualification of packaging components based on intended use.   This Webinar will explain the baseline requirements for elastomeric physicochemical and functional properties.  Examples to illustrate qualification of components for intended applications will be included.  A strategy for testing the entire packaging and delivery system inclusive of  the drug product is essential.  These USP updates are meant to increase patient safety by reducing risk through more thorough product understanding beyond component level testing, and these significant changes will be highlighted. 

Diane Paskiet

Director - Scientific Affairs

West Pharmaceutical Services, Inc.

Diane Paskiet has over twenty five years of experience with qualifying packaging and delivery systems for use with pharmaceutical products. She is Currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of packaging systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and awarded the PDA 2019 Packaging Science Award. She serves on the USP Packaging Storage and Distribution Committee and as Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group.

Daniel Bantz

Technology Manager, Packaging & Performance
West Pharmaceutical Services, Inc.

Daniel Bantz has over 25 years practical experience in medical and analytical instrumentation development and testing.  He’s competent in fluid metering product development and testing, combination product testing and device reliability testing.  Additionally, he has been trained in FMEA best practices and has developed product risk mitigation strategies and platforms across multiple organizations.  Daniel implements testing strategies meeting ever-changing regulations in conjunction with customer needs and the competitive landscape.  He earned an MBA in Operations and Technology from Aurora University in Illinois.

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Sours: https://pages.questexnetwork.com/WestPharma-091720-Registration.html?source=Listing
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