European Pharmaceutical Review

NOVEMBER 24, 2022

Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. One area in which the problem can be tackled effectively is product packaging. Quality assurances through the use of holograms.

Packaging 95

Packaging Labelling Documentation Dosage 95

pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). Sheena Macpherson.

Documentation 98

Documentation Packaging 98

The FDA Law Blog

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

FDA 64

FDA Packaging Documentation 64

Pharmaceutical Technology

MARCH 30, 2023

On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

PharmaShots

JUNE 1, 2023

We presented our first results this year at ESMO and ESMO-IO. These new results reinforce our differentiating data package for PDC*lung01. The target population of PDC*lung is initially limited to HLA-A2+ patients, as the PDC*line HLA-A2 cell line is used to load and present the selected antigens.

Immunization 40

Immunization Vaccines Health and Personal Care Stores Labelling 40

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

Packaging 52

Packaging Documentation Communication Data Entry 52

Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. CROs and sponsors use remote source document verification, as approved by the regulator pre-war. In July, approximately a third of companies had paused a trial in the country.

Packaging 52

Packaging Documentation 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. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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.

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

SEPTEMBER 11, 2023

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. link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

AUGUST 29, 2022

Such changes can include increasing batch sizes, adding manufacturing facilities, creating new product presentations, and updating analytical methods. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Common Technical Document [CTD] sections).

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

JULY 6, 2023

Operational Flexibility/Capacity Decentralized manufacturing Presently, portable end-to-end CM plants are not a widespread reality, but have been proven possible. addresses the risk-based decision-making process as a consequence of the previously defined level of formality, alongside the levels of effort and documentation.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

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. 16 8 Medicines Agency.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

SEPTEMBER 10, 2023

In these countries, a secondary packaging site change or an active pharmaceutical ingredient (API) manufacturing site addition triggers a new submission equivalent to that required for approval of a generic drug or a line extension, whereas these site changes may be filed as a notification in the US and EU. Published March 2020.

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Documentation Process Improvement Packaging Pharmaceutical Companies 98

Pharmaceutical Technology

NOVEMBER 28, 2022

A growing ageing population presents many challenges for health services globally that are already buckling under the strain of recovering from Covid-19, and wearable tech is providing a solution. We source as much of the materials as we possibly can locally, even packaging,” he notes. We have the skills. Printing is done in Glasgow.

Packaging 52

Packaging Hospitals Medical Schools Documentation 52