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.

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The Pharma Data

JANUARY 6, 2021

Discover five good manufacturing practices for water monitoring and sanitization for pharmaceutical use. 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. Download Your Copy.

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Compliance Manufacturing Regulation Contamination 52

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.

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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.

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XTalks

AUGUST 15, 2024

These tiny particles, primarily from environmental contamination, can infiltrate the food supply. In this episode of the Xtalks Food Podcast, Sydney talks about how microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised.

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Roots Analysis

JANUARY 12, 2023

The focus of stakeholders has now shifted to optimizing the cell therapies manufacturing process. For the success of cell-based therapies , an effective manufacturing platform and a robust supply chain model is imperative. The key steps involved in the supply chain of cell therapies manufacturing are presented below.

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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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.

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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. In more serious instances, sponsors might see their products recalled entirely.

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Roots Analysis

SEPTEMBER 20, 2023

The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is worth noting that manufacturing process biologics and cell therapies is considerably complex when compared to small molecule drugs. The key steps involved in the supply chain of cell therapy manufacturing are presented below.

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The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer.

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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. Tjoapack employs advanced materials and sealing technologies to ensure that the packaging provides an effective barrier against contaminants.

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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.

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FDA Law Blog

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. CGMP deviations caused 56 recalls, and excipient manufacturers performed 51 recalls due to contamination.

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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.

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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.

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FDA Law Blog

JUNE 17, 2024

The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog. Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA).

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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. Why do I write “exact same”?

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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?

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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.

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Delveinsight

SEPTEMBER 8, 2021

A group of experts specialized in the field of pharmacology deals with clinical/non-clinical testing, biologic design and manufacturing, regulatory agency interactions, submission preparation, and so on. From discovery to development and production of any biological product, aid in decision making is given by Pharma Consultants.

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XTalks

MAY 13, 2022

Manufacturers must conduct various tests such as stability and extractables and leachables (E&L) testing for packaging materials and enclosures to meet safety and efficacy guidelines. E&L testing is performed to substantiate that packaging materials will not contaminate the drug product over a product’s shelf life.

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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.

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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).

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Cloudbyz

AUGUST 19, 2024

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market.

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FDA Law Blog

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

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Pharmaceutical Technology

MAY 17, 2023

In addition to revolutionising diabetes care, insulin has become an essential component of biopharmaceutical manufacturing, where its growth-supplementing ­­­properties are relied on to enhance commercially available cell culture media and achieve higher yields of target therapeutic proteins. One big challenge is contamination.

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Pharmaceutical Technology

JULY 21, 2022

This minimises many sources of variability and contamination, which enhances sample accuracy and reproducibility by avoiding dead volumes, carryover and peak distortion. The SimplicityChrom CDS Software integrates the analytical workflow to offer an intuitive user experience when meeting compliance and traceability requirements.

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The Pharma Data

MARCH 29, 2022

an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Food and Drug Administration (FDA) announced today that Bravo Packing, Inc.,

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Pharmaceutical Technology

APRIL 27, 2023

This makes the requirement to establish a reliable and robust manufacturing process with clear scalability and compliance goals a priority. Every stage of development should result in a reproducible, safe drug product with no cross contamination from one batch to another. This is what SUT offers.”

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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pharmaphorum

AUGUST 4, 2022

For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches. Furthermore, by simulating real-life scenarios, AR offers the chance for staff in the pharma industry to practice complex operations without the associated risks.

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FDA Law Blog

NOVEMBER 22, 2022

coli contamination. On November 15, as part of the Agency’s implementation of the Food Safety and Modernization Act (FSMA), FDA released the f ood traceability final rule , which aims to reduce the occurrence of foodborne illnesses by enabling FDA to more efficiently identify and remove potentially contaminated food from the market.

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pharmaphorum

DECEMBER 23, 2022

The drug was rejected by the US regulator earlier this year a few months after the programme was placed on a clinical hold amid concerns about the drug’s manufacturing, specifically issued related to the possibility of sub-visible particulate contamination from the borosilicate glass vials that were originally used to produce the drug.

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The Pharma Data

APRIL 27, 2022

As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study , Toxic Elements in Food and Foodware program and sampling assignments,” said Susan Mayne, Ph.D.,

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Roots Analysis

OCTOBER 16, 2023

It involves the separation of unwanted particles from biological materials to obtain contaminant free products. This technique is commonly used in biologics manufacturing to remove cells, cell debris, and other large particles from the product. Particle Removal: This is the primary function of these filtration systems.

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FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

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