Pharmaceutical Technology

DECEMBER 8, 2022

This process is used to manufacture pharmaceutical products with low molecular weights in large batches within a short timescale. The chemical synthesis process enables various chemical modifications to be made in order to enhance the activity of the drug produced. Chemical synthesis solutions. Free Webinar. By ILC Dover.

Containment 245

Containment Contamination Manufacturing Production 245

XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

Production 98

Production Contamination Cosmetics Bacteria 98

Fierce Pharma

DECEMBER 27, 2023

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes.

Contamination 93

Contamination Production Drugs 93

Pharmaceutical Technology

MAY 2, 2023

FirstLine® is Datwyler’s most advanced manufacturing standard and production environment, combining new levels of quality and innovation with guaranteed reliability. The discovery of large quantities of nitrosamines in many drugs has led to a high number of product recalls, and new regulatory guidelines have quickly followed.

Packaging 130

Packaging Packaging Production Contamination 130

XTalks

MARCH 25, 2022

The affected medications include six lots of Accuretic tablets and batches of two authorized generics of the drug distributed by Greenstone that include one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/hydrochlorothiazide tablets.

Contamination 95

Contamination Drugs Production Manufacturing 95

Pharmaceutical Technology

JANUARY 6, 2023

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art. Without proper precautions, knowledge gaps can occur and important details may be overlooked when a product is transferred from one site to another. Simplicity matters.

Production 130

Production Manufacturing Development Bioequivalency 130

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

Packaging 98

Packaging Packaging Drugs Generic Pharmaceutical 98

Fierce Pharma

APRIL 10, 2024

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

Contamination 87

Contamination Manufacturing Production Drugs 87

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. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

STAT News

MARCH 31, 2023

Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a Food and Drug Administration inspection report obtained by STAT.

Contamination 105

Contamination Manufacturing Production Drugs 105

XTalks

AUGUST 12, 2024

The presence of lead in food remains a critical concern for the US Food and Drug Administration (FDA). Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods.

Contamination 105

Contamination Compliance Regulation Production 105

Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

Drugs 100

Drugs Packaging Packaging Production 100

STAT News

JANUARY 10, 2023

Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.

Contamination 105

Contamination Regulation Manufacturing Production 105

XTalks

AUGUST 4, 2023

The Trader Joe’s recall situation has garnered significant attention in the past week, as the popular retail chain declared three different product recalls during the last week of July. The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks.

Production 72

Production Contamination Manufacturing Licensing 72

XTalks

JUNE 14, 2022

The US Food and Drug Administration (FDA) found the 0.3 FL OZ (9 mL) nasal spray bottles to be contaminated with the bacteria, Providencia rettgeri. Previous and emerging research on this bacterium has associated it with intrinsic multi-drug resistance and nosocomial infections (also referred to as hospital-acquired infections).

Contamination 52

Contamination Bacterium Bacteria Branding 52

STAT News

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. Continue to STAT+ to read the full story…

Contamination 98

Contamination Manufacturing Regulation Production 98

STAT News

APRIL 3, 2023

We hope your journey today is meaningful and productive. Your tips and insights help the world go around… Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated , according to a U.S.

Manufacturing 97

Manufacturing Contamination Research Production 97

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.

Contamination 98

Contamination Containment Production Packaging 98

XTalks

JULY 22, 2021

Pfizer is recalling three more lots of its smoking cessation drug Chantix (varenicline) after having issued a voluntary recall of the drug earlier this month due to carcinogen concerns, bringing the total number of affected lots to 12. As a result, there are currently shortages of the drug in the US. mg and 1 mg doses.

Drugs 98

Drugs Doctors Doctor Branding 98

BioSpace

FEBRUARY 3, 2021

From packaging errors and contaminants to serious adverse effects, there are many reasons why products in the life sciences industry get recalled. Here’s a look at some of the latest drug and medical device recalls.

Contamination 72

Contamination Life Science Packaging Packaging 72

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use.

Regulation 98

Regulation Drugs Manufacturing Production 98

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

Containment 130

Containment Development Drugs Contract Manufacturing 130

Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. With operator intervention being a primary source of contamination, finding ways to reduce human contact has been an ongoing challenge and goal in aseptic filling.

Regulation 130

Regulation Contamination Manufacturing Production 130

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.

Contamination 78

Contamination Production Bacteria Nurses 78

Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs. Finding solutions.

Containment 130

Containment Manufacturing Production Contract Manufacturing 130

Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. Alternatively, they can come as a product component of formulations such as cleaning agents and polymers. Particle analysis on a micro-scale is a significant topic in several fields of application.

Contamination 130

Contamination Filler Bioavailability Production 130

XTalks

NOVEMBER 22, 2022

Last week, the US Food and Drug Administration (FDA) issued its final rule on Requirements for Additional Traceability Records for Certain Foods , which includes food traceability protocols for a variety of food products susceptible to contamination. Related: Here’s How the FDA is Making it Easier to Trace Foods.

Contamination 98

Contamination Manufacturing Production Drugs 98

pharmaphorum

JANUARY 30, 2023

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field.

Contamination 52

Contamination Manufacturing Production Containment 52

XTalks

JULY 26, 2021

Traditional meat production faces a wide array of safety concerns, from slaughterhouse sanitation to foodborne illnesses and much more. But just because plant-based meat production doesn’t involve slaughterhouses or mass production lines, doesn’t mean it is immune from safety concerns. Ultra-Processed.

Protein 98

Protein Contamination Allergies Bacteria 98

Pharma Packaging Solutions

SEPTEMBER 8, 2022

It’s extremely essential to protect pharmaceutical products from damage during shipping and distribution, as faulty medication could have disastrous consequences for consumers. That’s why the drug packaging process is so important, and must be carried out correctly. Primary packaging is the first step in the drug packaging process.

Packaging 52

Packaging Packaging Drugs Pharma Packaging 52

Pharmaceutical Technology

NOVEMBER 15, 2022

Manufacturers are actively looking at ways they can improve drug delivery through well-designed parenteral packaging systems, and the choice to deploy prefilled syringes for more and more injectable drug products is a key part of this push. Prefilled syringes offer a number of advantages over the more traditional glass vial.

Packaging 130

Packaging Packaging Vaccination Vaccine 130

Roots Analysis

JANUARY 27, 2025

These therapies have emerged as viable alternatives to traditional treatment options, including small molecule drugs. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs. This figure presents the cell therapy manufacturing steps.

Manufacturing 40

Manufacturing Contamination Production Gene Therapy 40

pharmaphorum

AUGUST 11, 2022

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

Sales 105

Sales Contamination Marketing Production 105

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). While this act is intended to make it easier for consumers with food allergies to identify potential allergens in the products they purchase, many believe it falls short.

Allergies 98

Allergies Manufacturing Contamination Production 98

XTalks

APRIL 12, 2022

the owner of Kinder Chocolate, Nutella and Tic Tacs, among other brands, is voluntarily recalling its Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats basket, due to possible Salmonella contamination. Ferrero U.S.A., In France, 21 cases of the same strain have been reported so far, eight of whom were hospitalized.

Production 98

Production Contamination Bacteria Regulation 98

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

Packaging 52

Packaging Packaging Drugs Generic Pharmaceutical 52

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

Manufacturing 130

Manufacturing Production Containment Contamination 130