LifeProNow

MARCH 10, 2023

million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health.

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Labelling Packaging Controlled Substances 130

FDA Law Blog: Biosimilars

JULY 22, 2024

Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” s John W.M. s John W.M. You can register for the conference here. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

Packaging 59

Packaging Labelling 59

GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Different products should not be packaged in proximity unless physical segregation exists. Please look at the labeling operation in the picture below.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

PharmaShots

APRIL 5, 2023

Udenyca is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation The approval was based on the comprehensive analytical data package, along with a PK, PD, and immunogenicity study. The results showed that 1171 out of 1605 patients were originator-naïve, retention rates @1yr.

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Biosimilars Packaging Labelling Hospitals 49

Express Pharma

JUNE 2, 2023

As part of these efforts, the government has implemented regulations mandating API (active pharmaceutical ingredient) manufacturers and pharma brands to incorporate barcoding on product packaging. This regulatory step is aimed at preventing falsified medicines from entering the market.

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Adverse Reactions Packaging Documentation Dosage 103

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Biosimilars Packaging Labelling Drug Development 130

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting.

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Communication Packaging Labelling 68

PharmaShots

MARCH 1, 2023

osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss The submission was based on the comprehensive analytical and clinical data package, incl. It will be available as a 300mg concentrate for solution for infusion’ Related Post: Insights+ Key Biosimilars Events of January 2023

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Biosimilars Packaging Labelling 40

Pharmaceutical Technology

JUNE 18, 2025

Subjects who conclude the trial will be qualified for an open-label extension trial. By GlobalData Learn more about Strategic Intelligence The study is assessing the safety and efficacy of 15 mg or 30 mg of the therapy against a placebo, administered once daily for 12 weeks to those with genetically and phenotypically defined MELAS.

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Communication Hospitals Packaging Labelling 52

pharmaphorum

JANUARY 30, 2023

More specifically on the current situation, they added, “Recently, shortages have been exacerbated by geopolitical events or trends, such as the war in Ukraine, the energy crisis, high inflation rates, as well as the recent surge of COVID-19 cases in China.” Indeed, China plays a crucial role in the supply of antibiotics.

Generic Medicine 104

Generic Medicine Packaging Labelling 104

GMPSOP

FEBRUARY 25, 2023

Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Sampling is carried out on intermediate processed materials and tested to ensure those are formulated correctly, free from contamination and qualified for filling and packaging. as their visual aids.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Pharmaceutical Technology

JUNE 23, 2025

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Like Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections, giving it market advantage. Sign up for our daily news round-up!

Biosimilars 52

Biosimilars Pharmaceutical Manufacturing Communication Hospitals 52

FDA Law Blog: Biosimilars

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

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Labelling Packaging 45

pharmaphorum

AUGUST 19, 2020

Reggie Foster , Senior Director Labelling, Logistics & Packaging, Kite: a Gilead Company. Our community of supply chain experts are looking forward to connecting with you in the digital world, including: Christopher Baldwin , Supply Chain Director, Cell & Gene Therapy¸ GSK.

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Packaging Labelling 52

Quality Matters

AUGUST 3, 2023

They comprise interconnected webs of local and global ingredient suppliers, manufacturers, packagers, distributors, providers, and regulators. active ingredients, excipients, other raw materials) Packaging materials (e.g., ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g.,

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

RX Note

OCTOBER 5, 2023

Medication Error The term "medication error" is used to describe any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer. Use Tall Man lettering Use additional warning labels for LASA medicines.

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Health and Personal Care Stores Labelling Packaging Compounding 52

Pharmaceutical Technology

JANUARY 15, 2023

Using the manufacturing contract-related data collated from PharmSource reports, and news from the GlobalData Pharma Intelligence Center, Pharmaceutical Technology has collated some of the key regulatory events from late November to late December that will likely impact manufacturing volumes, and stakeholders that will likely be affected.

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Labelling Packaging Communication Diabetes 52

RX Note

DECEMBER 16, 2023

Introduction Medication error is any preventable event that may harm patient. I did not identify any errors on medication label and the quantity prepared. Also, similar packaging design across medication strengths can lead to inadvertent selection errors, potentially impacting patient safety. Sertraline 100 mg OD.

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Labelling Dosage Medication Labelling Packaging 52

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. No serious adverse events were reported.

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Biosimilars Diabetes Immunization Immunity 105

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 28, 2024

Deviations are unusual or unexplained events that can potentially impact product quality, system integrity, or personal safety. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. What is deviation?

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

AUGUST 23, 2022

The tool can also be used for any other quality and compliance issues where a risk event is repetitive and a quality decision is urgent. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)?

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

MARCH 8, 2024

Out of trend results What is the origin of out of specification events? The court ruled that any individual OOS event should be investigated, and if a laboratory error cannot be identified, the batch will fail the test. Each tablet has the label claim of 100mg (w/w). Access to exclusive content for an affordable fee.

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Documentation Dosage Pharmaceutical Manufacturing Packaging 52

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021.

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Adverse Reactions Packaging Labelling Diabetes 52

Quality Matters

APRIL 26, 2023

FDA are co-hosting the APEC Medical Product Supply Chain Dialogue as a signature event of the U.S. While much has happened since USP’s CoE designation – including the COVID-19 pandemic, advances in technology, and geopolitical realignment in the region – science-based regulatory cooperation remains a key focus for APEC stakeholders.

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Prescription Filling Generic Medicine Packaging Labelling 52

GMPSOP

MARCH 17, 2023

In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. A fresh lot of unprinted cartons was issued for printing.

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Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

MARCH 4, 2023

Quality risk management involves the art and science of identifying, analyzing, assessing, and managing uncertain events. Events that can impact product quality or compliance with registered dossier throughout a product’s life. In most cases, these questions need to be asked before a risk event would potentially occur.

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Documentation Communication Method Validation Packaging 52

Pharmaceutical Technology

JUNE 13, 2025

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Credit: © AbbVie Inc. All rights reserved.

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Labelling Communication Hospitals Vaccines 52

LifeProNow

JANUARY 18, 2025

At data cutoff in May 2024, safety and tolerability data presented at ESMO demonstrated a low occurrence of Grade 3 or higher treatment-related adverse events (TRAEs) (9 percent); five patients had TRAEs leading to discontinuation (6 percent) and no treatment-related deaths were reported.

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Packaging Labelling 100

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. These regulations recognize that product quality can be significantly impacted if manufacturing and packaging have taken place.

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Labelling Packaging Documentation Inventory Control 52

Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients.

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Packaging Biosimilars Labelling Vaccines 105

Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. In an overview, the event comprised a business programme packed with sessions, roundtables and panel discussions.

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Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 105

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. – According to the CDC , adverse drug events cause around 1.3

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Health and Personal Care Stores Labelling Packaging Documentation 52

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items.

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Health and Personal Care Stores Labelling Immunization Immunity 66

Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.

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Labelling Communication Hospitals Vaccines 52

PharmaTech

JUNE 6, 2025

In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling. MS provides mass information allowing identification of N-glycan compositions.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

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Pharmacy Technician Diabetes Compounding Pharmacies Pharmacy Management 26