ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

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ISPE

OCTOBER 28, 2022

My primary role is to work with more than 20 ISPE Communities of Practice (CoPs) and Special Interest Groups (SIGs) that generate much of the key ISPE output: Guidance Documents, webinars, PE magazine articles, iSpeak Blog posts, training materials, and conference content.

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ISPE

MAY 8, 2023

Hence the importance and focus on regional facilities in this edition of PE magazine. These emerging markets, especially Latin America and the India subcontinent, are the ones that can see the most significant increase in pharmaceutical sales over the next three to five years.

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ISPE

MARCH 8, 2023

To learn more about APQ Guides and other ISPE Guides, visit ISPE.org/publications/guidance-documents Learn More & Buy Meet the ISPE Staff: Tina Li In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. PE Magazine Wants You!

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

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ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. The assessment may also identify perception concerns. Biological (Viral and Microbial) Risk Progression. Unlock Access to Member-Only Content. Company Name.

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Viseven

AUGUST 7, 2024

Therefore, it is always a good idea to include, for example, patient handouts along with healthcare magazine articles. As most documents come in a PDF format, Adobe Acrobat is helpful for this task. They also tend to prefer writers who can produce content for diverse audiences.

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pharmaphorum

MAY 26, 2022

“It’s a very time-consuming process because a person is just sitting, flipping through (medical) magazines and looking if a drug is mentioned in a publication,” says Dmytro Horilyk, Chief Executive Officer at DrugCard, SaaS-platform for automated medical literature monitoring.

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ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

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ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. m/s up to 0.54

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ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 6 (Note: The terms “pharmaceutical” and “pharma” interchangeably employ throughout this article.)

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Chemotherapy Documentation Dosage Communication 52

ISPE

JANUARY 8, 2023

In this process, documentation regarding the decisions made is important to justify the model and explainability mechanism selection in an audit context. However, it is important to critically reflect the decisions made so far, as more understanding of the use case will be gained once the first models are evaluated.

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ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc.

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ISPE

MARCH 15, 2023

There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. Accessed 28 December 2022: www.ipa.fraunhofer.de/en/expertise/ultraclean-technology-and-micromanufacturing/cleanliness-suitable-equipment-and-components/Cleanroom-suitable-materials.html

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ISPE

SEPTEMBER 10, 2023

Existing regulatory frameworks In the 1950s and 1960s, the WHO published documents outlining how countries should set up a regulatory framework to control pharmaceuticals and ensure the safety of their subjects. The proposals are consistent with WHO GRP. Published March 2020. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

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Pharma Mirror

MARCH 25, 2025

Clinical trials have grown increasingly complex and now require robust solutions to manage data, documentation, and workflows.

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