XTalks

MAY 5, 2022

Based on the science from the researchers who established the framework of modern Paleolithic nutrition, the program aims to provide guidance for the food industry by codifying Paleo Diet standards and making them available to manufacturers, retailers and other partners. billion by 2027, growing at a compound annual growth rate (CAGR) of 3.6

Packaging 98

Packaging Packaging Licensing Licensing 98

XTalks

JULY 26, 2024

In today’s rapidly evolving food industry, enterprise resource planning (ERP) systems for food manufacturers are essential. They ensure efficiency, compliance and profitability. Wherefour , a leader in ERP solutions, is transforming and simplifying how food and beverage companies manage production and compliance.

Compliance 52

Compliance Manufacturing Production Packaging 52

Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. International Standards and Classifications Compliance doesn’t end with the EU GMP certifications.

Packaging 52

Packaging Packaging Regulation Pharma Packaging 52

Pharma Packaging Solutions

NOVEMBER 8, 2024

Medical device packaging plays a key role in ensuring the safety, efficacy, and integrity of medical devices from the point of manufacture to the end-user. At Tjoapack, we are a premier provider of top-tier medical device packaging services. The packaging must adhere to guidelines set by authorities such as the FDA and EU GMP.

Packaging 52

Packaging Packaging Pharma Packaging Compliance 52

Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing. Advanced manufacturing technology and expertise in formulation sciences and process development are critical.

Manufacturing 130

Manufacturing Production Pharma Companies Development 130

Pharmaceutical Technology

JANUARY 20, 2023

While using renewable energy for manufacturing will help with green credentials, some producers are also considering continuous manufacturing. This is a more efficient alternative to batch manufacturing, combining multiple production stages into a single, continuous production line.

Manufacturing 356

Manufacturing Clinical Trials Clinical Trials Production 356

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

Pharma Packaging Solutions

NOVEMBER 1, 2024

At Tjoapack, we are your premier provider of private label pharmaceutical packaging solutions. The Appeal of Private Label Pharmaceuticals Private label pharmaceuticals, also known as store brands or own brands, are products manufactured by one company but sold under the brand name of a retailer or another company.

Packaging 52

Packaging Packaging Pharma Packaging Branding 52

XTalks

JANUARY 29, 2025

Philadelphia, PA PCI Pharma Services (“PCI”), a leading global contract development and manufacturing organization (CDMO) specializing in complex biopharma therapies, has announced a monumental investment exceeding $365 million.

Drug Delivery 52

Drug Delivery Production Packaging Packaging 52

Pharma Packaging Solutions

SEPTEMBER 15, 2022

Pharmaceutical packaging companies play a critical role in the pharmaceutical industry. Thus, choosing a packaging company to partner with is a very important decision. Here are a few things to consider when selecting a pharmaceutical contract manufacturing company. Regulatory Compliance. Capabilities.

Packaging 52

Packaging Packaging Contract Manufacturing Pharma Packaging 52

Pharma Packaging Solutions

JUNE 9, 2023

Quality medical device packaging is crucial for the health and well-being of countless people all around the world. With such an important job to do, it’s essential that the medical device packaging you choose for your product is up to the task. Here are a few factors to take into consideration when selecting medical device packaging.

Packaging 52

Packaging Packaging Pharma Packaging Compliance 52

Camargo

NOVEMBER 15, 2021

FDA Publishes ICH Guidelines on Continuous Manufacturing. The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.” Batch steps include filter drying, milling, and packaging.

Development 187

Development Manufacturing Production Packaging 187

Roots Analysis

APRIL 20, 2022

This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. . 3] Some of the advantages offered by pharmaceutical secondary packaging have been depicted below. Company Competitiveness Analysis.

Packaging 52

Packaging Packaging Marketing Production 52

Advarra

SEPTEMBER 8, 2022

Many companies use good automated manufacturing practice (GAMP), while others choose to focus on the Part 11 requirements and write validation procedures for their company to follow. After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance.

Compliance 52

Compliance Regulation Packaging Packaging 52

XTalks

OCTOBER 12, 2022

Once every two years, food manufacturers must undergo the US Food and Drug Administration (FDA) registration renewal process to ensure and uphold food safety. Agents, owners or operators of food manufacturing facilities must go through the FDA registration renewal process before the deadline. If not, the registration will be rejected.

Manufacturing 52

Manufacturing Packaging Packaging Production 52

pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

Manufacturing 98

Manufacturing Pharma Packaging Production Packaging 98

XTalks

JULY 19, 2024

The term “daily value” is central to understanding the Nutrition Facts label, a staple on nearly every packaged food product in the US since 1994. In practice, this involves collaboration between the FDA, the USDA and food manufacturers. Packaging also plays a role.

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Packaging Packaging Compliance Production 91

Pharma Packaging Solutions

NOVEMBER 11, 2024

At Tjoapack, we are your reliable provider of comprehensive medical device kitting services, customized to meet the unique needs of healthcare providers and manufacturers. By providing all required components in one package, medical device kitting reduces the duration of procedures and improves overall productivity.

Packaging 52

Packaging Packaging Compliance Pharma Packaging 52

Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Pharma in Brief

DECEMBER 3, 2020

The proposed amendments to the FDR will allow COVID-19 products that were previously approved under the Interim Order for Drugs and Vaccines to apply for a notice of compliance ( NOC ) using a similar streamlined regulatory process. Manufacturers would be required to provide bilingual labelling under certain circumstances.

Vaccination 98

Vaccination Vaccine Drugs Manufacturing 98

Cloudbyz

MAY 11, 2023

Investigational Product and Comparator Costs The costs of manufacturing, packaging, labeling, and shipping investigational products and comparators can add significantly to clinical trial expenses. These costs may also involve audits, inspections, and any corrective actions required to address compliance issues.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

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 Packaging Compliance Manufacturing 45

FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

Production 40

Production Compliance Manufacturing Regulation 40

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

FDA Law Blog

FEBRUARY 21, 2024

It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. Subpart B – Supplemental Provisions Subpart B – Supplemental Provisions, adds requirements related to control of records (new § 820.35) and device labeling and packaging controls (new § 820.45).

Regulation 59

Regulation Manufacturing Packaging Packaging 59

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT.

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Containment Manufacturing Production Regulation 130

pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Delve into the considerations for material components for the development of primary packaging. Speakers Include: Sebastian Stening, Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer. Michael Becker, Packaging Engineer, Boehringer Ingelheim.

Drugs 52

Drugs Packaging Packaging Drug Delivery 52

FDA Law Blog

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.

Packaging 52

Packaging Packaging Production Manufacturing 52

XTalks

AUGUST 15, 2024

Despite concerns, current evidence does not show significant migration of these particles from plastic food packaging into foods and beverages. They enhance the ability to trace the history, location and application of items, which is vital for quality control and regulatory compliance.

Contamination 52

Contamination Compliance Packaging Packaging 52

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

FDA Law Blog

MARCH 6, 2022

It is very common for a medical device manufacturing facility both to be certified as compliant with ISO 13485 and to have quality system procedures designed to comply with the FDA’s QSR. The gap between QSR requirements and ISO standards has created confusion for companies that focused compliance only on ISO certification.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

Drugs 52

Drugs Containment Packaging Packaging 52

FDA Law Blog

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

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Genome Genomics Manufacturing Production 102

The Pharma Data

AUGUST 7, 2020

CluePoints provides clinical studies with risk management support package during Covid-19. Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “The response to our complimentary risk assessment package has been fantastic. Dr. Francis S. Download the e-book here. Source link.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. and the EU are very similar.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

Clinical Supply 52

Clinical Supply Gene Therapy Gene Development 52

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40