ISPE

SEPTEMBER 10, 2023

As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC) changes that pharmaceutical manufacturers submit after implementing improvements or optimizations.

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The FDA Law Blog

DECEMBER 8, 2022

In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g., All packaged foods served or sold on transportation carriers (e.g., 1, 2023, sesame. lampreys); Bony fish (e.g., trout); and.

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ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. 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).

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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. McQueen Nina S.

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Impact Pharmaceutical Services

SEPTEMBER 28, 2023

The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must request an exemption through an Investigational New Drug (IND) application.

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Roots Analysis

FEBRUARY 27, 2023

Off-site builds or modular construction is a powerful way to reform construction business saving more time, labor, cost and productivity mutually benefitting the manufacturer as well as the customer. Types of Modular Construction Modular Construction can be broadly categorized into two categories, namely permanent and relocatable.

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ISPE

JANUARY 10, 2023

An agile regulatory pathway to implement alternative filters and resins into manufacturing is necessary to ensure the continued supply of approved biologics. For critical filters and resins in manufacturing of biological therapeutics, each health authority typically requires approval before final product distribution using alternatives.

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Packaging FDA Communication Vaccines 52

ISPE

OCTOBER 31, 2022

Winners of these awards exemplify the ideals of FOYA and demonstrate ISPE’s dedication to enhancing patient health thru advancements in pharmaceutical manufacturing. FOYA awards were presented in the following categories: Innovation - CRISPR Therapeutics for their facility in Framingham, Massachusetts. Tony Crincoli.

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ISPE

OCTOBER 31, 2022

Winners of these awards exemplify the ideals of FOYA and demonstrate ISPE’s dedication to enhancing patient health thru advancements in pharmaceutical manufacturing. FOYA awards were presented in the following categories: Innovation - CRISPR Therapeutics for their facility in Framingham, Massachusetts. Tony Crincoli. Takeda Pharma.

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Vaccines Packaging 52

ISPE

OCTOBER 31, 2022

Winners of these awards exemplify the ideals of FOYA and demonstrate ISPE’s dedication to enhancing patient health thru advancements in pharmaceutical manufacturing. FOYA awards were presented in the following categories: Innovation - CRISPR Therapeutics for their facility in Framingham, Massachusetts. Tony Crincoli. Takeda Pharma.

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ISPE

MARCH 24, 2023

When surveyed, 92% (35/38) of respondents indicated they are willing to take additional actions in handling the single-use assemblies and/or packaging to allow for better end of life management. Packaging sorting is a simpler action that could be more easily adopted. Supplier optimizing packaging/reducing packaging waste.

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Packaging 52

pharmaphorum

OCTOBER 29, 2021

They were supported in the latest round by Alkeon Capital and Whale Rock with a $200 million secondary investment package that gives them a stake in the firm. MSK conditions have become a key target for the digital health sector, and Hinge Health is just one company active in this category.

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Packaging 52

ISPE

MARCH 15, 2023

While the term sustainability encompasses a wide scope of goals, in examining manufacturing environmental sustainability we address reducing environmental burdens and progressing to more circular economies throughout the product and manufacturing process life cycle. Green Manufacturing for the Pharmaceutical Industry.”

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ISPE

MARCH 14, 2023

1 The growing applicability of SUT in manufacturing of biopharmaceuticals has led to large increases in the demand for Single-Use components and assemblies. The Disposables CoP received feedback from small to large firms (>1000 employees) in a survey of the industry’s manufacturers.

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ISPE

MARCH 8, 2023

However, few studies have analyzed contamination trends to enable a more effective risk-based approach to control contamination in the manufacture of medicinal products. The number and breakdown by contaminants/impurities are provided in Table 1.

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Compounding Compounding Pharmacies Packaging FDA 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Common Technical Document [CTD] sections).

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Documentation FDA Communication Packaging 52

ISPE

MAY 9, 2023

When companies pursue drug registration in these markets, the need for additional country-specific documents—such as certificates of pharmaceutical products (CPPs), Good Manufacturing Practice (GMP) certificates, site master files, and various types of declarations—may deter or delay progress and prevent timely patient access to drugs.

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Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.

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ISPE

OCTOBER 27, 2022

This platform technology is being adopted by growing ranks of large pharmaceutical manufacturers via licensure and acquisitions and by dozens of innovators. There has been significant global interest in investment to rapidly expand commercial and clinical manufacturing capacity. 1 Moumné, L., Marie, and N. Crouvezier.

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pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients. Silica microtaggants.

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ISPE

MARCH 29, 2023

One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.

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Documentation Dosage Packaging Communication 52

ISPE

JULY 6, 2023

In recent years, global pharmaceutical supply chains, still based on traditional batch- and intermediates-based manufacturing, were overwhelmed by their own vulnerabilities and inefficiencies, and were stressed to the brink of failure as a result of the SARS-COV-2 pandemic. It is recognized as a key process intensification approach.

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ISPE

OCTOBER 27, 2022

Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for classic product biopharmaceuticals. C sponsors currently address numerous emerging pharmaceutical entities, as well as manufacturing platforms, modes, and scale. At-scale manufacturing operations and flow. Stephen Judd.

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ISPE

JANUARY 11, 2023

Robbins 1 January 2023 Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M. mg residue).

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The Checkup by Singlecare

FEBRUARY 8, 2024

Zyrtec is also in the same category as other nonsedating antihistamine allergy pills such as Claritin (loratadine) and Allegra (fexofenadine). Generic cetirizine is made by various pharmaceutical manufacturers. Zyrtec was approved by the United States Food and Drug Administration (FDA) in 1995. mL or 5 mL once daily or 2.5

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ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. These are a heterogenous class of GHG emissions associated with purchased goods and services to manufacture and distribute a given product.

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European Pharmaceutical Review

OCTOBER 2, 2023

Silvia Forroova, Director of partnerships & sustainability, Informa Markets, commented: “We are very excited to be back in Barcelona, one of Europe’s premier biotech and pharma manufacturing hubs. At the heart of pharma, we provide the vital connections that will underpin growth in pharma manufacturing in the next few years.

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Packaging 99

The FDA Law Blog

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

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European Pharmaceutical Review

SEPTEMBER 15, 2023

For its 20 th anniversary, more than 180 entries across 12 categories have been narrowed down to determine the finalists the upcoming CPHI Pharma Awards. To recognise the influx of innovation across the pharmaceutical industry, three new categories are included in this year’s awards. Are you coming to the CPHI Barcelona 2023?

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Packaging 113

Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. Procurement methods, at any health system level, typically comprise the following categories: restricted tender, open tender, direct procurement, competitive negotiation, and international and local shopping.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

The FDA Law Blog

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). and Banco Bilbao Vizcaya Argentaria S.A

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European Pharmaceutical Review

FEBRUARY 22, 2023

These] data give us confidence to move forward with multiple programmes in parallel…and to expand manufacturing scale-up,” shared Imran. “We The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. the enteric coating and the capsule dissolve.

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Pharmaceutical Technology

OCTOBER 23, 2022

Arbitrary limits given as milligrams of exposure to residues per device were simply prescribed based on the physical contact time allowed for each category of device. It is therefore essential that EO sterilized articles are subjected to sufficient aeration to remove such residues prior to final packaging by manufacturers.

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Packaging 40

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. PDC*line can also be easily manufactured, as the cell source is independent of patients, and the drug product is shortly available for the patients.

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Immunization Vaccines Health and Personal Care Stores Labelling 40

The Thyroid Pharmacist

JULY 29, 2022

Indoor sources include flame retardants, upholstery, flooring and manufactured wood products, cleaning agents, etc. In this study, 25 “fragranced” products including laundry detergents, fabric softeners, dryer sheets, air fresheners and the like (many were top sellers within their product category) were tested. Heavy Metals.

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