ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. Case Study One: Packaging Materials The first case study looks at developing more sustainable packaging materials and reducing the size of packaging materials. Let’s use the example of the packaging for medicines.

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DiversifyRx

NOVEMBER 24, 2023

If you think that doesn’t happen nowadays, here’s an article about recent counterfeit HIV medications. This tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement. It also enables precise tracking and tracing of each drug package.

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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.

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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.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The original article can be found HERE. The DSCSA Adventure continues. Identifiers All products received must contain a product identifier.

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ISPE

JANUARY 11, 2023

1 , 2 This article explores the life-cycle approach to cleaning topical drugs and cosmetics with attention to the cleaning design phase and leveraging this information, including lab studies and pilot runs, for qualifying and monitoring the cleaning process. 1 US Food and Drug Administration.

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ISPE

SEPTEMBER 11, 2023

This article provides background knowledge from literature and data from experiments to enhance the discussion. The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 x, a free and open-source computational fluid dynamics (CFD) software package. m/s up to 0.54 m/s to 1.0

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ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

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ISPE

MARCH 7, 2023

This article explores effective management and oversight processes for accelerated delivery of large-scale programs of work. We hope this article inspires the following considerations: Has my company set the right level of ambition to help combat climate change? that apply to the scope of activities undertaken by their organization.

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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., 16 Health Canada.

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The Checkup by Singlecare

MARCH 10, 2025

In this article, well take a closer look at semaglutide, its costs, and alternatives that may be offered. Learn more from our article on how to get Wegovy covered by insurance. Your healthcare provider will need to provide documentation to support your request for coverage. Is semaglutide covered by insurance?

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients.

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pharmaphorum

JANUARY 18, 2022

Primary Packaging material designers. Secondary packagers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Overview of the workshop: The workshop is aimed to provide an introduction to the key elements of the Medical Device Regulation that Companies affected by article 117 need to consider.

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The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud. The Food and Drug Administration brags that: “The U.S. Here’s the kicker.

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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.

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Board Vitals - Pharmacist

NOVEMBER 8, 2022

Step 4: Applying and integrating the evidence “ As clinicians, we need to be confident in our decision-making,” writes Shannon Casey in a recent Medpage article. Once clinicians have translated their research and skills into practice, they need to learn how to measure, quantify and document the outcomes data.

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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. Genetic Engineering and Biotechnology News. 5 October 2022.

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The Digital Apothecary

APRIL 26, 2019

Most of the time they want to pick my brain on where pharmacy is going or what could be possible, so with that being the case, I thought it would be better to put this article together that may help potentially interested parties. Even some of the most recent pitches are very similar to each other I feel. So let's get started!

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Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on.

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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. en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf 9 European Commission.

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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. Risk-Based Decision-Making ICH Q9(R1) Section 5.2

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European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

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European Pharmaceutical Review

APRIL 14, 2025

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). That proposed Directive contains a similar regulatory framework for decentralised manufacturing (see prospective Articles 142-153). But the UK framework will arrive first.

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