XTalks

JULY 25, 2024

They enhance the ability to trace the history, location and application of items, which is vital for quality control and regulatory compliance. For instance, if a contamination is detected, the platform can pinpoint the affected batches and locations, enabling swift recalls. One primary reason is regulatory compliance.

Compliance 52

Compliance Contamination Production Manufacturing 52

XTalks

JULY 26, 2024

These tiny particles, primarily from environmental contamination, can infiltrate the food supply. Microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised. Macroplastics and microplastics are growing concerns within the food industry.

Contamination 52

Contamination Regulation Packaging Packaging 52

XTalks

AUGUST 26, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. In this episode of the Xtalks Food Podcast, Sydney talks about how lead contamination in food can arise and what the FDA is doing to monitor lead levels.

Contamination 52

Contamination Branding Compliance Regulation 52

pharmaphorum

JUNE 8, 2022

Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0

Compliance 52

Compliance Contamination Manufacturing Production 52

pharmaphorum

SEPTEMBER 23, 2020

The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation. Workshop B 13.30 – 17.30

Contamination 52

Contamination Compliance Containment Regulation 52

The Pharma Data

JANUARY 13, 2021

Avoid risking the quality of water in manufacturing practice, subsequent product process delays and compliance issues with this handy guidebook. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark.

Compliance 52

Compliance Manufacturing Regulation Contamination 52

The Pharma Data

JANUARY 6, 2021

. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Meet compliance regulations and conductivity measurements. Ensure water system control. Download Your Copy.

Compliance 52

Compliance Manufacturing Regulation Contamination 52

Pharma Packaging Solutions

NOVEMBER 8, 2024

Tjoapack employs advanced materials and sealing technologies to ensure that the packaging provides an effective barrier against contaminants. Regulatory Compliance Compliance with regulatory standards is essential in medical device packaging. The packaging must adhere to guidelines set by authorities such as the FDA and EU GMP.

Packaging 52

Packaging Packaging Pharma Packaging Compliance 52

Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. GDP is Key to Maintaining Compliance Want to instill confidence in your GxP?

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. Enter cleanrooms-on-demand….

Manufacturing 98

Manufacturing Pharma Packaging Production Packaging 98

FDA Law Blog

NOVEMBER 30, 2022

The purpose of the PAI was to determine whether the facility has a quality system that was designed to achieve sufficient control over the facility and commercial manufacturing operations and evaluate the facility’s Good Manufacturing Practice (GMP) compliance.

FDA Approval 72

FDA Approval Manufacturing Compliance Contamination 72

Pharma Packaging Solutions

SEPTEMBER 8, 2022

As the main line of defense between a drug and its environment, primary packaging must be able to prevent contamination and chemical alterations. . It is often necessary for both regulatory compliance and consumer protection. . Once a drug has undergone primary packaging, secondary packaging can begin.

Packaging 52

Packaging Packaging Drugs Pharma Packaging 52

XTalks

AUGUST 11, 2023

Healthcare facilities management roles can be categorized into distinct areas: Operations, Maintenance, Security, Compliance and Facility Development. With a pronounced emphasis on healthcare, the company delivers all-encompassing solutions backed by technical expertise, aiming to fortify product safety and sanitation against contamination.

Compliance 96

Compliance Contamination Production Marketing 96

Pharmaceutical Technology

JUNE 14, 2023

Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. Many small and mid-cap companies lack the expertise for regulatory compliance and high containment facilities and thus seek to outsource NMEs (New Molecular Entities) requiring special handling.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130

XTalks

FEBRUARY 21, 2022

The company also said that quality control is a crucial aspect of the manufacturing process, which is why it will help to ensure the identity, composition, strength, purity (including the absence of product- and process-related impurities) and absence of microbiological contamination of each batch that is produced.

Vaccine 105

Vaccine Vaccination Production Manufacturing 105

FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

Containment 45

Containment Contamination Manufacturing Compliance 45

XTalks

AUGUST 3, 2023

In a statement released after the decision, Johnson & Johnson said it will appeal the ruling, saying LTL launched its bankruptcy case “in good faith and in strict compliance with the Bankruptcy Code.” And in determining financial distress, “observing smoke may not be enough — one must see flames,” Kaplan wrote.

Compliance 98

Compliance Contamination Research Life Science 98

pharmaphorum

OCTOBER 7, 2020

FDA regulator and founder of Barragan BioConsulting, where she offers Regulatory and Compliance consulting services to pharmaceutical companies globally. During my presentation, I will discuss about humans as ecosystems and how they pose a source of contamination risk during the manufacture of biopharmaceuticals.

Contamination 52

Contamination Production Manufacturing Compliance 52

The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Reviewing nitrosamine contamination. Continuous professional development. Upcoming in Regulatory Focus What’s coming in May?

Development 52

Development Contamination In-Vitro Production 52

FDA Law Blog

NOVEMBER 9, 2023

food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. Like The Marvelettes , FDA is tired of wondering when its mail will arrive and “waitin’ so patiently” for importers to achieve compliance. Comments on the proposed rule can be submitted here until January 30, 2024.

Regulation 52

Regulation Compliance Contamination Containment 52

FDA Law Blog

JULY 18, 2023

CGMP deviations caused 56 recalls, and excipient manufacturers performed 51 recalls due to contamination. FDA’s PHE-focused testing found more troubles with sanitizers, as all the non-compliant COVID tests came from hand sanitizer products that were either subpotent or contaminated with impurities.

Manufacturing 52

Manufacturing Production Contamination Drugs 52

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. This is extremely important for injectable medications.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

FDA Law Blog

OCTOBER 31, 2021

The product or packaging is part of, and in compliance with, a program established on or after January 1, 2022, governing the recyclability of that product or packaging and the director of CalRecycle determines that it will not increase contamination of curbside recycling or deceive consumers.

Packaging 52

Packaging Packaging Containment Production 52

Roots Analysis

APRIL 15, 2024

It is worth noting that, any discrepancies encountered at this stage of manufacturing can lead to microbial contamination, subsequently resulting in loss of product, long development timelines and substantial financial burden for the drug developers, owing to the high cost of cell-derived raw materials.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Pharmacy Checkers

DECEMBER 12, 2019

A majority of inspections resulted in findings of non-compliance. In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. -based inspectors who go overseas, 66 remained unfilled.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Roots Analysis

JANUARY 12, 2023

However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure. The key steps involved in the supply chain of cell therapies manufacturing are presented below.

Manufacturing 40

Manufacturing Production Contamination Medicine 40

Roots Analysis

MAY 24, 2024

These autoinjectors offer several advantages, including simplified drug administration process, safer injection, reduced risk of contamination and minimized maintenance ( due to elimination of cleaning and sterilization steps ). This is extremely important for injectable medications.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

The Pharma Data

NOVEMBER 18, 2020

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes. and improve public health.

Regulation 52

Regulation Compliance Contamination Marketing 52

FDA Law Blog

JUNE 17, 2024

Of the 94 quality-related Warning Letters, 80% were issued to manufacturers of OTC drugs—over half of which manufactured either hand sanitizer or products that could be contaminated with diethylene glycol (DEG) or ethylene glycol (EG). FDA issued 94 Warning Letters in FY2023, approaching its previous high from FY2019.

Manufacturing 59

Manufacturing Drugs Production Contamination 59

Delveinsight

SEPTEMBER 8, 2021

Another task for Pharma Consultants is Pharmacovigilance that is relatable to the collection, detection, assessment, monitoring, and prevention of adverse effects with biologicals, they also work in the area of resolving contamination issues. Pharma Consultancy Modus Operandi. Market Assessment & Operational Sales.

Marketing 52

Marketing Production Sales Life Science 52

Roots Analysis

SEPTEMBER 20, 2023

However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure. Contamination is a key concern when it comes to manufacturing cell therapy products.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

The Pharma Data

FEBRUARY 18, 2022

In partnership with local quality control testing labs, BioNTech will help to ensure the identity, composition, strength, purity, absence of product- and process-related impurities, as well as the absence of microbiological contamination of each produced batch. The first BioNTainer is expected to arrive in Africa in the second half of 2022.

Manufacturing 40

Manufacturing Vaccine Vaccination Production 40

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

Cloudbyz

AUGUST 19, 2024

Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. Regulatory compliance: Labels must comply with the regulations of the country in which the device is marketed, including language requirements, symbols, and content.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Pharmaceutical Technology

MARCH 30, 2023

At the start of this year, the World Health Organisation (WHO) said that more than 300 children had died in The Gambia, Indonesia and Uzbekistan in 2022 in deaths linked to contaminated medicine. The medicines – over-the-counter cough syrup – were contaminated with ethylene glycol (EG) and diethylene glycol (DEG).

Compliance 130

Compliance Manufacturing Contamination Medicine 130

FDA Law Blog

MAY 19, 2023

Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance. Within 60 days and continuing for 3 years, sponsors will be required to include the results of that testing in the device’s labeling along with details about the samples used for the testing.

Reagent 40

Reagent Genetics Contamination Marketing 40

XTalks

MAY 13, 2022

E&L testing is performed to substantiate that packaging materials will not contaminate the drug product over a product’s shelf life. These compounds thus become a part of the drug matrix. As such, E&L studies are designed to evaluate the package material and drug compatibility. > umbrella).

Packaging 98

Packaging Packaging Containment Production 98