European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety. Register your details to read more The post How ready are you?

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.

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Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111

Packaging Labelling Documentation Dosage 111

Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

Packaging 40

Packaging Documentation Vaccines 40

pharmaphorum

JANUARY 12, 2022

Those packages include S4DX’ Satellite app for sample management, imito’s medical image and documentation handling software, decide’s GlucoTab insulin dosing tool, CardioSignal for monitoring cardiac rhythms, and SteadySense’s continuous temperature measurement tool SteadyTemp.

Hospitals 128

Hospitals Patient Care Packaging Documentation 128

European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 96

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. AI-supported spectroscopy delivers superior pharmaceutical packaging QC The post European regulators prepare for AI in pharma appeared first on European Pharmaceutical Review.

Packaging 105

Packaging Documentation 105

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

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

Pharmaceutical Technology

JULY 15, 2022

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

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Insurance Documentation Packaging 131

The FDA Law Blog

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. There are those who are willing to read through the more extensive package consisting of all the reviews.

Documentation 59

Documentation FDA Packaging 59

Pharmaceutical Technology

SEPTEMBER 5, 2022

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.

Documentation 52

Documentation Packaging Labelling Pharmaceutical Companies 52

pharmaphorum

FEBRUARY 10, 2021

It will also produce policy documents and information packages for patients, doctors and senior management in companies, Other workstreams could include computational strategies to make such simulations more powerful and efficient, new curricula to educate the workforce on the development and use of the technologies.

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Packaging Documentation Hospitals 76

The FDA Law Blog

JULY 10, 2023

In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). When referencing documents within the AI response, cite location within the 510(k) supplement (e.g., Attachment number) and document name or description as appropriate.

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FDA Documentation Packaging Communication 75

The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA 59

FDA Labelling Packaging Documentation 59

Pharmaceutical Technology

MAY 17, 2023

Marketing Packages Taking part in the Excellence Awards offer your company many benefits including being able to tell the market, new and prospective clients about your achievement. For full details on the benefits, the scale of our audience and the marketing packages on offer please download the RESEARCH GUIDE.

Packaging 52

Packaging Documentation 52

pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages.

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Documentation Vaccines Packaging Pharmaceutical Companies 98

Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

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Documentation Packaging Vaccines 59

Omnicell

JANUARY 10, 2023

Stephanie Gallagher, PharmD, MBA Senior Clinical Product Marketing Manager, Omnicell Imagine if Amazon lost one out of every 10 packages. So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? Or the airlines lost 10% of passenger bags.

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Sterile Compounds Compounding Omnicell Documentation 52

The Checkup by Singlecare

MARCH 6, 2023

“However, since children’s dosing recommendations may vary between Benadryl products, it’s best to check the package label for dosing instructions to ensure appropriate and safe dosing,” says Dr. Johnson-Arbor. Dosing for the topical versions of Benadryl will differ, so always follow package instructions or consult your healthcare provider.

Health and Personal Care Stores 98

Health and Personal Care Stores Packaging Documentation Dosage 98

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.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Packaging 45

Packaging Labelling FDA Documentation 45

Impact Pharmaceutical Services

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

Documentation 59

Documentation FDA Packaging 59

The Checkup by Singlecare

MARCH 10, 2025

Certain insurance plans (such as ones from Blue Cross Blue Shield and United Healthcare ) may cover Ozempic but require prior authorization for coverage, meaning the prescriber needs to provide information such as blood tests or documentation to prove a treatment is medically necessary. affected by a shortage).

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Compounding Insurance Insurance Coverage FDA 52

DiversifyRx

OCTOBER 20, 2022

’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient. Their parents can pick up the tests from you and send them in their next care package. Do not just autofill all these at-home tests and ship them out if the patients do not want them.

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Insurance Packaging Documentation Communication 98

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. Many organizations already have documented process maps.

Packaging 52

Packaging Documentation Communication Data Entry 52

The Checkup by Singlecare

FEBRUARY 28, 2024

When applying for Medicaid in Pennsylvania, applicants must submit documentation to prove their U.S. Medical services covered Health services covered by Pennsylvania Medicaid vary slightly between eligibility groups, with children receiving the most comprehensive benefit package. citizenship, refugee, or lawful non-citizen status.

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Packaging Documentation Hospitals Insurance 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 40

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

pharmaphorum

NOVEMBER 27, 2020

The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments. Teva introduced its generic modafinil product to the UK at half the price and Cephalon responded with an infringement lawsuit alleging infringement of its patents.

Packaging 52

Packaging Documentation 52

DiversifyRx

NOVEMBER 24, 2023

This tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. It also enables precise tracking and tracing of each drug package.

Independent Pharmacies 40

Independent Pharmacies Packaging Documentation FDA 40

The FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Meeting package content, timing of submission, and directions for submission are also covered by this Guidance.

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FDA Packaging Documentation 59

Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation FDA Packaging Labelling 40

Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation FDA Packaging Labelling 40

ISPE

JANUARY 10, 2023

This can be found seven times in the entire document. aseptic processing line, filling zone, stopper bowl, open primary packaging or for making aseptic connections under the protection of first air).". In the new EU GMP Annex 1, the consideration of first air plays an important part.

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Packaging Documentation 96

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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FDA Packaging Documentation 64

Pharmaceutical Technology

SEPTEMBER 8, 2022

Packaging. • The information contained within the download document is intended for pharmacists, pharmaceutical executives, sales managers, manufacturers, business development managers, pharmaceutical sales representatives, and any other individual involved in the pharmaceutical compounding sector. Excipients. Lab batch production.

Compounding 40

Compounding Compounding Pharmacies Sterile Compounds Dosage 40