FDA Law Blog: Biosimilars

MARCH 8, 2023

Acknowledgement 3 notifies the submitter that the submission was either successfully loaded into CDRH’s adverse event database or that the submission contained errors, which will be specified in the letter. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

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Packaging Communication 57

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

Packaging 62

Packaging Communication 62

Viseven

JUNE 12, 2023

APAC Pharma Challenges — The Viseven Event Summary, April 2023 Digital maturity, personalized customer engagement, and data-driven marketing have been accepted and implemented in Europe and the US for a few years. As of 2022, APAC accounts for 57% of Phase I clinical trials and 49% of Phase II clinical trials worldwide.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 52

pharmaphorum

MARCH 16, 2022

Part 1 of this article discussed the massive disruptions to medical events caused by the COVID-19 pandemic and how attendees’ preferences have shifted as things have shaken out. In the pharmaceutical industry digital marketing is nothing new, but in the context of onsite-and-online events it is. How to make it in the new normal.

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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., Global supply chains are complex and vulnerable to disruption.

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

pharmaphorum

NOVEMBER 27, 2022

Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication. This increase in complexity has left the industry wide open to supply chain shocks from events such as the pandemic, regional conflict, trade disputes, and cyber-attacks.

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Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

National Association of Boards of Pharmacy

JULY 19, 2024

This means it is unlikely event the largest dispensers will be ready given there is only around four months until the end of the stabilization period on November 27 th , 2024. So, what does this all mean for DSCSA implementation for the dispenser community? Gathering transaction information for recalls at the package level.

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Pharmacy Technician Documentation Communication Packaging 45

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. Individual blame logic aims at finding the guilty individuals.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. Regions which were once the sources of raw materials may be plagued by adverse weather events, hindering production and causing inflated costs. What are the Main Pharmaceutical Procurement Methods?

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Packaging Pharmaceutical Companies Pharmaceutical Companies Dosage 52

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

PharmaKinnex

AUGUST 23, 2022

Primarily because of a fact that the pharmaceutical industry has known for some time—constant, honest, and meaningful communication with prescribers is lacking in the post-pandemic world. Fewer Networking & Industry Trade Show Events. Why you may ask? Are Pharma Sales Representatives “Over?”

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Communication Packaging 52

GMPSOP

AUGUST 28, 2023

When the raw materials, components, and packaging materials arrive from the supplier, the first thing you should do is verify the goods match with records such as purchase order and delivery docket. It is important to assign in-house lot numbers for every container received next to the supplier’s lots of raw materials or packaging materials.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

PharmaState Academy

FEBRUARY 29, 2024

Communicating the value proposition through various channels such as physician detailing, patient education materials, and digital marketing campaigns. Engaging in competitive intelligence gathering through industry conferences, trade shows, and networking events to stay abreast of industry developments and competitor strategies.

Health and Personal Care Stores 52

Health and Personal Care Stores Hospitals Communication Customer Service 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

epicur

AUGUST 8, 2023

It often starts with communication. Product Shortages Product shortages are inevitable and variable, stemming from product recalls, labor shortages , unavailability of necessary packaging, or active pharmaceutical ingredients (APIs). Make sure you check in with colleagues, notice signs of stress, and offer help.

Compounding 52

Compounding Documentation Compounding Pharmacies Packaging 52

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)? process change, product recall, labelling change, adverse event/safety reporting)?

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

RX Note

DECEMBER 16, 2023

Introduction Medication error is any preventable event that may harm patient. This incident highlights the potential dangers of unconventional medical abbreviations in prescription communication. Also, similar packaging design across medication strengths can lead to inadvertent selection errors, potentially impacting patient safety.

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Labelling Dosage Medication Labelling Packaging 52

Quality Matters

MAY 23, 2023

Furthermore, 38% of Americans have been exposed to an event where someone received a substandard or counterfeit prescription medication from an online source, according to the ASOP survey. For example, his group analyzed antibiotics purchased online and the potential safety risks specific to that treatment category.

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. 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. No, this will be a violation of good laboratory practice.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

OCTOBER 16, 2022

Master Manufacturing Instructions and Master Packaging Instructions). Skill Booster Good documentation practice in memos and emails If a memo to file must be used to record an event, issue data or other information, the following requirements should be met: i. It’s challanging, it’s refreshing and it’s FREE.

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Documentation Data Entry Communication Packaging 40

European Pharmaceutical Review

JUNE 24, 2022

These events led to the publication of the EU Pharmaceuticals Strategy in 2020, 1 which, in addition to a range of other activities, aims to ensure the regulatory system for human medicines is future? It is too early to say because we have not seen the whole package of measures yet. About the author. References. European Commission.

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Compounding Drug Development Drug Pricing Dosage 105

GMPSOP

JULY 31, 2023

– High-Speed Tablet/Capsule Counting Machines (Critical for accurate counting and packaging of tablets and capsules). Alarm and safety test: Acceptance Criteria: The autoclave’s alarms should activate and safety interlocks should function correctly when triggered by predefined events or conditions.

Documentation 52

Documentation Dosage Labelling Data Entry 52

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. How to Use Take 1-2 capsules of GI Detox after exposure to a reactive food, or in the event of food poisoning.

Health and Personal Care Stores 96

Health and Personal Care Stores Immunity Immunization Compounding 96

RX Note

FEBRUARY 23, 2023

G6PD Deficiency - Explaining G6PD Deficiency Ramadan - Medications during Ramadan fasting Adverse Drug Reactions Adverse Drug Reactions - All adverse reactions are adverse drug event Pharmacovigilance - To detect unreported ADRs Drug Allergy - Management vary based on the signs and symptoms Medicine-induced Discolouration - Red?

HIV Treatment and Prevention Agents 75

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Packaging Vaccines Labelling Communication 59

Pharmaceutical Technology

JANUARY 20, 2023

Wildfires, floods, landslides, and drought, often in places unused to such extreme weather events, are causing a global shift in public health issues and can quickly lead to a humanitarian crisis. Pharma manufacturing can also be affected by extreme weather events, such as storms. Please check your email to download the Whitepaper.

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Pharmaceutical Companies Pharmaceutical Companies Packaging Communication 142

Pharmaceutical Technology

MARCH 22, 2023

Impact of global events moving forward Despite government incentives to bring down energy costs, Gupta predicts that API manufacturers will continue to look for alternative sites outside the EU to maintain profit margins. The question is whether rising inflation levels and major global events will allow for development and innovation.

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Pharmaceutical Manufacturing Packaging Communication Diabetes 105

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

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

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Drug Development Compounding Dosage Packaging 98

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Please check your email to download the Webinar.

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Drug Development Packaging Communication 52

Pharmaceutical Technology

NOVEMBER 28, 2022

We source as much of the materials as we possibly can locally, even packaging,” he notes. When we need new packaging, it is really simple to get and it is quick. Building up data over time also allows for pinpointing when any health fluctuations occur and the monitoring of any changes. We have the skills. Printing is done in Glasgow.

Hospitals 52

Hospitals Packaging Medical Schools Documentation 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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Packaging Chemotherapy Labelling Communication 52