European Pharmaceutical Review

JULY 10, 2023

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. Evaluation of Ames assay test conditions for N -nitrosamines is ongoing, with a goal to identify the most robust Ames testing conditions, EMA reported in the revision document.

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Documentation FDA 97

IDStewardship

SEPTEMBER 2, 2022

In this article an expert in clinical information design provides his insights, discussing reasons why some guidelines do not get used along with solutions to these problems. Article Posted 2 September 2022. These updates go into effect January 2023 and can be found here. Interview with: Michael Long, Ph.D. BCPS, BCIDP.

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Hospitals Documentation Formulary Information Medication Guidelines 130

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. References European Commission, (26 April 2023). Article 63 EMA (29 January 2020). Euractiv (6 October 2023). Article 63 PGEU (2023).

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Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 86

IDStewardship

MAY 12, 2023

In this article five tips for incoming PGY2 pharmacy residents is provided. BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Core resources can include society guidelines, ACCP Self Assessment Program chapters , review articles, key specialty books (e.g.,

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Communication Documentation Vaccines 130

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023. Gauthier, Pharm.D.,

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Hospitals Documentation Communication Patient Care 236

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. The online consultation will run until 8 November 2023. A version of this article was originally published by our sister publication The Pharmacist.

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Hospitals Community Pharmacies Documentation Communication 52

Hospital Pharmacy Europe

SEPTEMBER 26, 2023

Following the PSA’s review, published on 25 September 2023 , the GPhC assured that resolving FtP cases in a timely way was an ‘absolute priority’ and it committed to making improvements in this area. This article was originally published by our sister publication The Pharmacist.

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Documentation Hospitals 105

The FDA Law Blog

FEBRUARY 27, 2023

This error has appeared not just in articles and other news publications but in some court documents as well. Gilbert — One misnomer that has been repeated over the years has been the reference to the “Drug Enforcement Administration” (“DEA”) as the “Drug Enforcement Agency.” The DEA has even made the same mistake. Merrick Garland, et.

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Documentation Controlled Substances FDA 45

ISPE

NOVEMBER 2, 2022

The gavel passed to a new International Board Chair and ISPE leaders shared 2022 achievements and plans for 2023 at the 2022 ISPE Membership Meeting and Awards Lunch. Highlights were presented about what to expect in 2023 from ISPE leadership and Board members, and recipients of the 2022 ISPE International Honor Awards were announced.

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Documentation Compounding Communication FDA 52

ISPE

MARCH 8, 2023

ISPE Briefs: New Guide Promotes Cultural Excellence Trudy Patterson Wed, 03/08/2023 - 10:07 InTouch March / April 2023 ISPE Briefs: New Guide Promotes Cultural Excellence Marcy Sanford 1 March 2023 Cultural excellence is the expressed and implied ways in which an organization operates. Articles can be 400 to 1,000 words.

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Documentation Communication 52

PQA

JUNE 16, 2023

In a new viewpoint article from PQA, Merck and the University of Arizona College of Pharmacy, we present three reasons for new MTM quality measures and offer recommendations on next steps to achieve this. PQA's 3rd Quarter 2023 Stakeholder Advisory Meeting is August 2, 1-1:30 pm ET. data sources), and usability. See our recent blog.

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Documentation Vaccines 40

Hospital Pharmacy Europe

SEPTEMBER 26, 2023

Following the PSA’s review, published on 25 September 2023 , the GPhC assured that resolving FtP cases in a timely way was an ‘absolute priority’ and it committed to making improvements in this area. This article was originally published by our sister publication The Pharmacist.

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Documentation Hospitals 52

ISPE

FEBRUARY 16, 2023

Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View Trudy Patterson Thu, 02/16/2023 - 09:23 iSpeak Blog iSpeak Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View Mark Birse Jean-Francois Duliere Alfred W. equipment is not available)? Pharma 4.0 ™ and Annex 1 Conference.

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Documentation FDA 52

The Checkup by Singlecare

DECEMBER 26, 2023

After submitting documentation, your insurance provider will review your requested medical services to determine if they’ll help cover your MRI’s partial or total costs or if you’ll be responsible for out-of-pocket costs.

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Insurance Insurance Coverage Hospitals Mayo Clinic 64

pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

The Checkup by Singlecare

OCTOBER 30, 2023

It’s important to note that this article doesn’t provide a complete list of all escitalopram interactions. Carefully read these documents as they contain important safety information, including information about interactions. This article does not provide a complete list of all escitalopram interactions.

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Communication Dosage Documentation 52

The Checkup by Singlecare

DECEMBER 1, 2023

Benjamin Feingold presented a hypothesis at the annual meeting of the American Medical Association suggesting that hyperactivity in children could be linked to the consumption of artificial food coloring, according to an article published in the journal Neurotherapeutics. FDA (2023) Is Red Dye 40 safe?

Labelling 52

Labelling FDA Documentation 52

ISPE

SEPTEMBER 1, 2023

Backup and Disaster Recovery To ensure continued data availability, the CSP should have a fully documented backup and disaster recovery plan that outlines backup frequency, primary and backup server locations, automated recovery methods, security measures for backups, and recovery point objectives (RPO).

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Communication Documentation 98

ISPE

MARCH 29, 2023

The Culture Club: Wrapping it up - Part 4 of 4 Trudy Patterson Wed, 03/29/2023 - 10:55 iSpeak Blog iSpeak The Culture Club: Wrapping it up - Part 4 of 4 Michelle Vuolo Levi Schenk Andre L. While working together during this journey, we found this article 1 that relates the Demming principles to today’s world. Walker, CPIP Brandi M.

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Documentation 96

European Pharmaceutical Review

JANUARY 10, 2024

This article discusses the complexity of microbiome-based medicinal products and the novel challenges being encountered to characterise and measure this complexity in a robust manner as they progress through the different stages of clinical development that can delay the progress of products to the market. cited 2023 Dec];336(6086):1325–9.

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Immunization Documentation 52

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. Rao Nicole Granda Alvarez Paul T. Lopolito Steven M. 1 US Food and Drug Administration.

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Method Validation Documentation Packaging Compounding 52

The Checkup by Singlecare

NOVEMBER 14, 2023

Examples of narcotic pain medications include: Vicodin (hydrocodone/ acetaminophen) Tylenol #3 (acetaminophen/ codeine) Ultram (tramadol) Roxicodone (oxycodone) Diphenhydramine-food interactions Diphenhydramine does not have any well-documented cases of interactions with food. A pharmacist or doctor can provide a complete list too.

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Labelling Dosage Compounding Medication Labelling 52

The People's Pharmacy

MAY 8, 2023

” Its investigation into foreign FDA inspections is shocking (April 19, 2023): “A ProPublica analysis of FDA inspection data as of April shows that the agency’s inspections of overseas drug manufacturers, located mostly in India and China, has dropped precipitously even as the number of manufacturers has remained relatively steady.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The Thyroid Pharmacist

JULY 14, 2023

In this article, you will learn about: How LLLT works Existing LLLT research Some uses and benefits of LLLT for thyroid health Laser therapy in clinical settings and LED devices for at-home use Can Thyroid Tissue Really Regenerate? I want to share some information about LLLT with you and discuss some interesting research.

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Dosage FDA Immunization Documentation 97

ISPE

JULY 6, 2023

ICH Q13 and What Is Next for Continuous Manufacturing Trudy Patterson Thu, 07/06/2023 - 06:51 Features July / August 2023 ICH Q13 and What Is Next for Continuous Manufacturing Gabriella Dahlgren, PhD Douglas B. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

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Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

NOVEMBER 1, 2022

All of this energy has been channeled by the International Board into a rewriting of the ISPE Strategic Plan for 2023–25 with a “more confident position: Shaping the Future of Pharma.”. Disclaimer : This article contains an abridged, unofficial summary of an FDA regulator’s presentation at a conference that has not been vetted by the agency.

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FDA Insurance Chemotherapy Documentation 98

ISPE

JULY 10, 2023

ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Trudy Patterson Mon, 07/10/2023 - 15:37 Technical July / August 2023 ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Martin Heitmann, FRM Stefan MÜNCH Brandi M. The response by ChatGPT is marked as ChatGPT.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MAY 11, 2023

Enhanced Intervention Detection in Aseptic Fill Using AI/ML Trudy Patterson Thu, 05/11/2023 - 10:32 Technical May / June 2023 Enhanced Intervention Detection in Aseptic Fill Using AI/ML Michelle Vuolo Christoph Koeth Robert J. Vials are rejected or discarded when critical zone intrusion is detected during operator interventions.

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ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

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Documentation FDA 98

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. In 2023, the FDA released final internationally harmonized guidance Q13 Continuous Manufacturing of Drug Substances and Drug Products.

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FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

Trudy Patterson Mon, 09/11/2023 - 06:10 Features September / October 2023 Air Speed Qualification: At Working Position or Working Level? This article provides background knowledge from literature and data from experiments to enhance the discussion. Air Speed Qualification: At Working Position or Working Level? m/s up to 0.54

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Documentation FDA Packaging Communication 52

ISPE

MAY 11, 2023

™ Roadmap Trudy Patterson Thu, 05/11/2023 - 13:25 Technical May / June 2023 Methodology to Define a Pharma 4.0™ ™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. Methodology to Define a Pharma 4.0™

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Packaging Documentation Communication Data Entry 52

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. 7 June 2023. Accessed 14 April 2023. Updated January 2023. McQueen Nina S.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 9, 2023

This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for estimating the recovery time to a particulate challenge per ISO 14644-3. To estimate the infiltrated door flows, design documentation can be used.

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Documentation Communication 52

ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Brown Megan E.

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Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 8, 2023

The document is based on a number of reports from the EU Commission and aims to ensure citizens’ trust in AI systems. AI Technical Documentation and GAMP ® 5 In GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) 2 , Article 11 1 describes the technical documentation needed.

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