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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Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 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. It supports the analysis of Industry 4.0 to Industry 4.0

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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.

Medical Schools 52

Medical Schools Hospitals Packaging Documentation 52

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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Documentation FDA Packaging Communication 52

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 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. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 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

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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 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., 16 Health Canada.

Documentation 52

Documentation FDA Communication Packaging 52

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.

Documentation 52

Documentation FDA Packaging Communication 52

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 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. Risk-Based Decision-Making ICH Q9(R1) Section 5.2

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

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.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

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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