XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container closure systems are highly regulated by health agencies. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing.

Packaging 98

Packaging Packaging Containment Production 98

Outsourcing Pharma

NOVEMBER 10, 2021

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

Packaging 69

Packaging Packaging Pharma Packaging Manufacturing 69

pharmaphorum

JUNE 10, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry.

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Packaging Packaging Manufacturing Pharma Packaging 52

Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.

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Generic Drugs Drugs Contamination Manufacturing 87

XTalks

OCTOBER 7, 2022

As awareness grows around the world about the problem of food waste, one culprit is being scrutinized: best before dates on food packaging. While food and beverage manufacturers have used the labels for decades to estimate peak freshness, consumers are confused about date codes, often causing more food waste than necessary.

Packaging 97

Packaging Packaging Manufacturing Production 97

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

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Manufacturing Sales Packaging Packaging 130

Pharma Packaging Solutions

NOVEMBER 4, 2024

In the complex world of pharmaceutical packaging, selecting the right blister packaging supplier is a critical decision that can significantly impact product presentation, protection, and compliance. At Tjoapack, we are a leading provider of blister packaging solutions designed to meet the unique needs of the pharmaceutical industry.

Contract Packaging 52

Contract Packaging Packaging Packaging Compliance 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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Contamination Manufacturing Containment Production 130

XTalks

MARCH 23, 2022

Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. . Respondents cited packaging as the top area brands should focus on if they want to increase purchase intent.

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Manufacturing Production Branding Packaging 119

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

XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Additional production would be performed at other facilities for final packaging. million, respectively.

Manufacturing 98

Manufacturing Vaccination Vaccine Drugs 98

Pharma Packaging Solutions

AUGUST 2, 2022

If you have ever taken any kind of medication, be it prescription or over the counter (and you almost certainly have), then you’re probably familiar with blister packaging. Blister packaging is extremely common in the pharmaceutical industry, thanks to its many benefits. Another benefit of blister packaging is convenience.

Packaging 52

Packaging Packaging Pharma Packaging Regulation 52

XTalks

SEPTEMBER 24, 2020

In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. Related: FDA Issues First Injunction of its Product Safety Rule. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

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Regulation Hormones Containment Packaging 94

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

Camargo

OCTOBER 20, 2021

The regulatory strategy for developing such products needs to be well-designed and should factor in both adaptability and the manufacturing process to minimize overall program risk. However, not every combination product can be classified so easily, and the OCP must follow certain work-flows and regulations to reach a decision.

Production 206

Production Regulation Drugs Development 206

XTalks

JUNE 20, 2024

This rule would mandate front-of-package nutrition labeling, which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back. The team discusses which design would be most effective and wonders whether this rule would promote healthier choices.

Packaging 59

Packaging Packaging Protein Manufacturing 59

Outsourcing Pharma

NOVEMBER 10, 2021

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

Packaging 52

Packaging Packaging Manufacturing Production 52

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

Marketing 173

Marketing Sales Manufacturing Drugs 173

Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

Packaging 40

Packaging Packaging Production Manufacturing 40

pharmaphorum

AUGUST 12, 2022

Embracing Continuous Manufacturing. Continuous manufacturing could be the solution. Unlike batch manufacturing, where drug production is segmented into a series of slow-moving steps, continuous manufacturing relies on a fully integrated process that runs uninterrupted from beginning to end.

Manufacturing 59

Manufacturing Production Drugs Regulation 59

pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. Sheena Macpherson. The algorithms used in healthcare are becoming more complex as well.

Production 98

Production Regulation Manufacturing Packaging 98

XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

Allergies 98

Allergies Packaging Packaging Containment 98

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

Regulation 52

Regulation Compliance Manufacturing Packaging 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

Camargo

JANUARY 12, 2022

INTERACT meeting discussions may focus on topics such as the design of IND-enabling toxicity studies, complex manufacturing technologies or processes, and the development of innovative devices to be used with drug or biologic products. Receipt of Background Package. Response Time. calendar days). At the time of the meeting request.

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Production Gene Therapy Packaging Packaging 169

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

Production 130

Production Containment Packaging Packaging 130

XTalks

SEPTEMBER 17, 2020

Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

Production 98

Production Contamination Cosmetics Bacteria 98

XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements.

Allergies 98

Allergies Manufacturing Contamination Production 98

XTalks

JULY 26, 2024

In today’s rapidly evolving food industry, enterprise resource planning (ERP) systems for food manufacturers are essential. The Importance of ERP Systems for Food Manufacturers ERP systems are crucial for the food and beverage industry. .” These features make Wherefour an essential tool for food manufacturers.

Compliance 52

Compliance Manufacturing Production Packaging 52

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

Regulation 45

Regulation Production Cosmetics Sales 45

Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

Marketing 130

Marketing Sales Manufacturing Drugs 130

XTalks

APRIL 14, 2022

Laura has more than 30 years of experience implementing food safety and quality control programs for packaging, processing, retail operations and food service. Laura has worked with global manufacturers and retailers in the implementation of their workplace and food safety programs.

Manufacturing 98

Manufacturing Regulation Packaging Packaging 98

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

XTalks

JULY 27, 2022

Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. Several other customers said they received leaking bottles of rotten-smelling sauce in the mail, with approximately 50 packages being impacted.

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FDA Approval Packaging Packaging Production 98

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59

pharmaphorum

NOVEMBER 26, 2020

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation. As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right.

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Vaccination Vaccine Life Science Regulation 105