FDA Law Blog

DECEMBER 13, 2021

In 2017, in an effort to lighten the burden for affected parties, FDA proposed to extend compliance dates until at least Jan. Despite opposition, FDA finalized the proposal to extend the compliance dates in March 2019. susceptibility of the produce to surface adhesion or internalization of contaminants); Environmental conditions (e.g.,

Compliance 52

Compliance Contamination Regulation Development 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 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

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 Compliance Manufacturing 45

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.,

Manufacturing 52

Manufacturing Contamination Cosmetics Regulation 52

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.

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Packaging Packaging Drugs Pharma Packaging 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

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

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.

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Manufacturing Contamination Production Drugs 52

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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Contamination Production Manufacturing Packaging 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

Worldwide Clinical Trials

JUNE 13, 2024

The study focused on several key factors: DNA Yield and Quality Sample Stability Assay Outcomes Patient Compliance DNA Yield and Quality The study found that blood samples typically yield a higher quantity of DNA compared to buccal swabs. Buccal swabs had a compliance rate of 95%, compared to 69% for blood samples.

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Medicine DNA Compliance Clinical Trials 182

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

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.

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Compliance Contamination Research Life Science 98

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

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.

Development 90

Development Manufacturing In-Vitro Compliance 90

Advarra

MARCH 31, 2023

IBC review ensures compliance with biosafety guidelines, issued by the National Institutes of Health (NIH) as well as the Centers for Disease Control and Prevention (CDC) , intended to protect the health and safety of research personnel as well as the community and environment around the research site.

Engineer 52

Engineer Genetics Clinical Research Research 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

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

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.

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Vaccination Vaccine Production Manufacturing 105

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

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.

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Manufacturing Production Contamination Gene Therapy 40

The Pharma Data

OCTOBER 30, 2020

Representatives of the legal department and the Department of Compliance, Risk Management, and Ethics (CRE) briefed the members on their roles and responsibilities. The Ethics Officer from CRE provided the Members and Advisers with an overview of the WHO Declaration of Interest process. Surveillance and Contact Tracing 6.

Regulation 52

Regulation Vaccination Vaccine Compliance 52

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

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.

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Manufacturing Production Vaccination Vaccine 40

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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Compliance Contamination Production Marketing 96

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

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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Compliance Production Contamination Engineer 130

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….

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Manufacturing Pharma Packaging Production Packaging 86

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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Drug Delivery Contamination Drugs Production 40

Drug Discovery World

JULY 11, 2024

Download this interactive infographic to: Discover ways to navigate your contamination, compliance, reproducibility, monitoring and scalability challenges Identify which critical factors and equipment you should consider to help succeed in a GMP environment Unlock access to an extensive collection of helpful resources The post Overcome your cell and (..)

Gene Therapy 52

Gene Therapy Gene Contamination Compliance 52

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.

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Drug Delivery Containment Contamination Production 40

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.

FDA Approval 52

FDA Approval Contamination Marketing RNA 52

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

Roots Analysis

OCTOBER 16, 2023

It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Biopharmaceutical filtration systems are designed to remove impurities and contaminants, to improve safety, purity and shelf life of the product. Particle Removal: This is the primary function of these filtration systems.

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Bacteria Production Contamination Protein 40

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

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 Compliance 71