ISPE

NOVEMBER 3, 2022

Health Canada has been working as part of a consortium since 2018, Hamel said. Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. From three applications in the first year, they are now working on eight.

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ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Paul indicated that in 2018, ICMRA introduced an Inspection Reliance Guideline which was adopted by PIC/S. Regulatory.

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European Pharmaceutical Review

JUNE 12, 2024

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2018; 66(5): 645–50.

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ISPE

JULY 6, 2023

This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done. Published 2018.

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The Thyroid Pharmacist

JUNE 14, 2023

In honor of Father’s Day, I want to recirculate my original Men’s Health article — with some updates. This article is dedicated to all of the special men in your life. (I You may have seen this article last year, around this time — some things have changed! His wife had Hashimoto’s.)

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The Thyroid Pharmacist

JULY 29, 2022

In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Check out my article on mold toxicity to learn more about reducing mold in your home. (I How airborne toxins can affect the thyroid.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Many organizations already have documented process maps.

Packaging 52

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European Pharmaceutical Review

JULY 1, 2022

In China, the Law on Protection of Women’s Rights and Interests was promulgated in 1992 and last amended in 2018. The PSCI encourages commitment and accountability, as well as documentation. No draft ordinance or order has been publicised as of the date of writing this article.

Pharmaceutical Companies 84

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ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. 24 August 2018. Published 2018. 5 October 2022.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

The Thyroid Pharmacist

DECEMBER 1, 2023

In this article, you’ll discover: The role of vitamin D within the body The link between vitamin D deficiency and thyroid conditions How to test for vitamin D deficiency Lifestyle tips and supplements to boost your vitamin D levels What is Vitamin D? Published 2018 Aug 16. Published 2018 Nov 26. Published 2018 Nov 11.

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The Thyroid Pharmacist

DECEMBER 7, 2022

In this article, you will learn: How your family is exposed to flame retardants. On a positive note (and why I wrote this article), there are ways to reduce the prevalence of these chemicals in your home and reduce the toxic load in your body. Read this article about NAC for more information about how it can support thyroid health. [32].

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Health and Personal Care Stores Labelling Immunization Compounding 58

ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. 38 (May/June 2018): 40–41. Q13 Continuous Manufacturing of Drug Substances and Drug Products.” March 2023. link] 16 Hausner, D.,

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

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.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. Published 24 September 2018. Published 24 January 2018. BioPharma Dive.

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ISPE

JANUARY 8, 2023

In this article, we elaborate on the benefits and requirements on xAI from a GxP point of view, along with the development and production process, with a focus on strategies to ensure that the intention of use is met and to manage risks for safety that arise from xAI itself. 12 November 2018. 2 Kilburn, F. link] 3 European Commission.

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Communication Documentation FDA 52

ISPE

MAY 10, 2023

This article discusses the main SPuMoNI accomplishments. 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. 10 April 2018.

Chemotherapy 52

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ISPE

JANUARY 9, 2023

Hayes Marc Ramoneda Rueda 1 January 2023 In this article, potential Pharma 4.0™ This article is the second part of the “Reimagining CPV for a Pharma 4.0™ ™ World” article published in the May–June 2022 issue of Pharmaceutical Engineering ® . 1 In that article, the business requirements were analyzed. are discussed.

Documentation 52

Documentation Communication 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

In this article, you’ll learn: Common causes behind low libido (and how the thyroid can affect this) Why conventional approaches to low libido don’t typically work in those with Hashimoto’s Natural solutions to increase low libido in both men and women What is Libido, and What Can Affect It? There are many natural solutions.

Dosage 91

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ISPE

SEPTEMBER 10, 2023

In this article, we describe the assessment of lag time for global regulatory approvals of postapproval CMC changes for multiple products over a three-year period. Published November 2018. IPRP Strategic Vision 2018–2021. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020.

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ISPE

MARCH 15, 2023

Facility electrification has several benefits, as described in such international energy management standards as ISO 50001:2018 EnMS, 26 European S.I. www.sciencedirect.com/science/article/pii/S0255270121004116 18 NHS. link] 26 ISO Standard 50001:2018 “Energy Management Systems —Requirements with Guidance.” August 2018.

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The Thyroid Pharmacist

JANUARY 20, 2023

For the purposes of this article, I’d love to do a deep-dive focus on adaptogenic herbs, as one way to increase our body’s resilience and lower the impact of all types of chronic stress. This article features a long list of adaptogens, each of which has fascinating and unique properties. percent of people with Graves’. [5]

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Pharmaceutical Technology

JUNE 22, 2023

According to the document, this scheme would instead harm patient access to drugs, which will take longer to turn generic. Årdal previously wrote about the voucher scheme in a February 2023 article published in The Lancet. Baraldi was one of the authors of The Lancet article alongside Årdal.

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