pharmaphorum

JANUARY 30, 2023

Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.

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XTalks

NOVEMBER 23, 2023

Salmonella Outbreak from Poultry — The US A widespread Salmonella outbreak linked to contaminated poultry affected thousands across multiple states this year. It also encouraged a citizen petition to make it illegal to sell poultry contaminated with any one of 31 strains of Salmonella. Coli Daycare Outbreak — Canada In September, an E.

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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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Manufacturing Production Contamination Gene Therapy 40

XTalks

APRIL 11, 2024

Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Manufacturing Hormones Contamination Contract Manufacturing 40

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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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each module contains six standard sized containers, which measure 2.6

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Containment Contamination Compliance Manufacturing 45

pharmaphorum

FEBRUARY 3, 2022

Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches. Uncover principles in best-practice and the benefits of a robust contamination control strategy. Who Should Attend?

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XTalks

AUGUST 25, 2023

The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens. But how does this differ from government-set standards?

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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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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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pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. 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

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XTalks

AUGUST 12, 2020

Thomson International, a company based out of Bakersfield, California, has recalled red, yellow, white and sweet yellow onions shipped from May 1, 2020 until now due to potential Salmonella contamination. of Bakersfield, California, USA, or any products made with these onions. More about Salmonella.

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pharmaphorum

JANUARY 24, 2022

The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. Assess engineering containment controls, from isolators and barriers to fully automated lines.

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Containment Engineer Contamination Manufacturing 52

XTalks

JULY 12, 2023

Despite its prevalent use in the broader food industry, fish bone detection still poses a challenge because fish bones have low density, contain minimal minerals and are incredibly thin, making them difficult to find. Historically, the main reason for installing X-ray equipment was metal contaminant detection.

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The Pharma Data

DECEMBER 30, 2020

30, 2020 — A hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, according to the U.S. In addition, the recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse is being expanded after manufacturer Sunstar Americas learned of 29 infections. WEDNESDAY, Dec. Shane Erickson Inc.

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Contamination Containment Production Bacteria 52

Pharma Packaging Solutions

AUGUST 3, 2023

Material All medical device packaging should be manufactured using materials that are both known and traceable. Additionally, the materials used should be non-toxic, odorless, and non-leaching to prevent any possible contamination of the device the packaging is designed to contain.

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Packaging Packaging Pharma Packaging Contamination 52

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

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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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pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development.

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XTalks

APRIL 14, 2023

“We voluntarily and proactively made the decision to pull some of our plant-based chicken products off store shelves and out of distribution because of an issue we discovered at our co-manufacturer,” Impossible Foods said in a company blog post. While this is a very atypical situation, this action was the obvious and right decision to make.”

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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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The Pharma Data

DECEMBER 30, 2020

Adding to the list of sketchy hand sanitizers and mouthwashes, a hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, CBS News reported Tuesday. Also, the recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse is being expanded after manufacturer Sunstar Americas learned of 29 infections.

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Pharma in Brief

AUGUST 9, 2021

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

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Pharmaceutical Technology

NOVEMBER 17, 2022

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Flexible containment solutions for potent APIs. Partnering with containment experts.

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Roots Analysis

APRIL 19, 2022

Upstream processing primarily involves the use of single-use bioreactors, sensors, filters, media bags and containers, while in downstream processes, single-use technology is used for chromatography, centrifugation, filtration, sampling system and connectors. [1] 1] The history of bioprocessing technology is mentioned below.

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Find Me Cure

SEPTEMBER 21, 2021

Many older homes still contain asbestos, putting residents at risk. Common asbestos-contaminated building materials are: Asbestos ceiling tiles. If your home was built before the 1980s, it may contain asbestos materials. Mines and manufacturers processed asbestos, turning the fibrous mineral into different forms.

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Licensing Licensing Containment Contamination 40

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. delivery Sale Zovirax Cold Sore Treatment Cream, Tube 2 g Zovirax contains aciclovir, an anti-viral treatment; always read the label Fights the cold sore virus Works at the tingle and blister £6.19 −£1.60 £4.59 What is Zovirax cream?

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XTalks

JANUARY 25, 2023

The Abbott baby formula plant was reportedly contaminated with Cronobacter sakazakii , a germ that can be found in dry foods and cause blood infections and meningitis in infants. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner?

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Bacteria Contamination Production Regulation 52

Drug Discovery World

JANUARY 19, 2023

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). coli cell bank that contains the plasmid. coli residual contaminants as well as product-related impurities.

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The Pharma Data

DECEMBER 28, 2020

With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”. Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-Looking Statements.

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Drug Discovery World

AUGUST 10, 2022

And as researchers study all of these factors, they are also discovering that CAR T cell development and manufacturing require a new approach to quality control to ensure their safety and efficacy. The challenge of manufacturing CAR T cells. Developing the first CAR T cell therapy.

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Manufacturing Gene Genome Genomics 98

XTalks

AUGUST 10, 2020

The report found that some food packaging, including burger boxes, wrappers, disposable bowls, and bags for french fries, sides and desserts — used at popular restaurants such as McDonald’s, Sweetgreen, and Wendy’s — may contain potentially hazardous PFAS chemicals. McDonald’s Big Mac clamshell container also appeared to be PFAS-treated.

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Packaging Packaging Contamination Containment 98

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

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