GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Pharmacy Joe

MAY 1, 2024

Subscribe on iTunes , Android , or Stitcher The label of “penicillin allergic” usually sticks to a patient’s medical record forever. The documented allergy was severe in nature for 13% of patients, moderate for 43%, and unknown for 44%.

Inpatient 98

Inpatient Medical Records Documentation Labelling 98

Pharma Marketing Network

MARCH 18, 2025

Best For: Thought leadership, industry networking, and professional event promotions. Avoiding misleading claims or unapproved off-label promotions. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Labelling 52

FDA Law Blog: Biosimilars

MAY 8, 2023

a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

Documentation 98

Documentation Labelling 98

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. – Please make sure that proper documentation is maintained and corrective action is undertaken.

Documentation 52

Documentation Dosage Pharmaceutical Manufacturing Packaging 52

GMPSOP

JUNE 28, 2024

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

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

pharmaphorum

FEBRUARY 25, 2021

We attended the Rare Disease Day Virtual Parliamentary Event to find out. This enables rapid assessment and decision making for requests that fall outside commissioned services, including off-label treatment. How has rare disease care changed over the last few years? And what might we expect from the next five?

Documentation 111

Documentation Labelling 111

Pharmacy Joe

FEBRUARY 26, 2025

The study was an open-label, multicenter, randomized controlled trial in 9 Australian Emergency Departments. Secondary outcomes included serious adverse events. There were no differences in serious adverse events between groups either. This difference was not statistically significant.

Hospitals 52

Hospitals Inpatient Documentation Labelling 52

GMPSOP

AUGUST 23, 2022

Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. Assessing validation failures/deviations 4. All written and updated by GMP experts.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

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. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

FEBRUARY 25, 2023

Finished product samples are drowned from packed products to check if the labels are applied correctly, batch number and expiry dates are correct and legible. You will also check printed labels that are affixed on primary containers display correct information (e.g., Additional documents included each month.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Pharmaceutical Technology

OCTOBER 13, 2022

In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. On 22 September, the MHRA expanded the label to include the use for sleep-onset insomnia in children with ADHD. No significant adverse events were reported.

Labelling 59

Labelling Dosage Documentation 59

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. Beyond the FDA, other institutions have documented what industry standards should look like in assessing RWD in a regulatory context. Furthermore, ECAs are well-documented in the post-approval setting.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

On July 7, 2023, armed with these new procedures, CDER notified Oncopeptides that it proposed expedited withdrawal of Pepaxto because the postapproval study failed to verify clinical benefit and because Pepaxto was not shown to be safe or effective under its conditions of use (the documents discussed herein are published in the docket here ).

Documentation 59

Documentation Labelling Drug Development 59

RX Note

JUNE 4, 2023

Introduction Once, I received a query from a ward nurse: If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge? What does a cool place on the product label mean? Read the label to know the recommended storage temperature range.

Drug Storage 52

Drug Storage Labelling Medication Labelling Documentation 52

pharmaphorum

OCTOBER 4, 2022

The FDA explains that regardless of the complexity of the software and whether or not the software is proprietary, the output or labelling should provide HCP users with adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation. Criteria for regulation.

Documentation 105

Documentation Labelling Communication 105

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Documentation 45

Documentation Labelling Communication 45

GMPSOP

MARCH 17, 2023

Additional documents included each month. – Status control: implementing status labels to clearly identify workflow status such as issues, returns, rejects and reworks of components to prevent mix ups. Additional documents included each month. Preventive action is taken to fix the cause of a problem before it can happen.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 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. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Communication Method Validation Packaging 52

Quality Matters

AUGUST 3, 2023

ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g., This risk assessment effort is not a one-time event but rather a periodic, recurring process for communicating and reviewing risks,” noted USP’s Horacio Pappa, Ph.D., active ingredients, excipients, other raw materials) Packaging materials (e.g.,

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Viseven

NOVEMBER 17, 2022

They provide information about the following: Off-label usage Publications Safety information Independent medical education. As a result of these developments, companies are trying to manage contact centers and create accurate response documents effectively. What do medical affairs teams do? .

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Additional documents included each month.

Labelling 52

Labelling Packaging Documentation Inventory Control 52

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 64

Labelling Communication Documentation 64

The Happy PharmD

OCTOBER 26, 2022

All events that jeopardized a patient’s safety, such as those involving falls, wrong surgical sites, clinical alarm mishaps, and other safety-related problems could result in a sentinel event. They were called sentinel events because of the immediate need for attention to address these errors. Every case was a sentinel event?

Hospitals 52

Hospitals Pharmacy Technician Labelling Medical Records 52

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 Additional documents included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

PharmaTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

LifeProNow

APRIL 9, 2023

These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. of patients. of patients. of patients.

Adverse Reactions 100

Adverse Reactions Labelling Documentation 100

pharmaphorum

SEPTEMBER 15, 2020

The external part of this is ensuring agility around adapting customer messages to meet the market needs with ‘quick-turn’ content updates that react to the events of today and tomorrow.”. The mindset that accomplished this needs to be retained,” Jeremy says.

Communication 130

Communication Documentation Labelling Vaccines 130

FDA Law Blog: Biosimilars

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

Labelling 59

Labelling Adverse Reactions Vaccines Documentation 59

pharmaphorum

DECEMBER 14, 2022

.” The experts reviewed data from the GALACTIC-HF trial, conducted when Cytokinetics was partnering the drug with Amgen, in which the drug met its primary objective of reducing cardiovascular death or heart failure events compared with placebo in HFrEF patients, cutting the combined rate by 8%. with omecamtiv mecarbil from 39.1%

Documentation 52

Documentation Labelling 52

PharmD Live

FEBRUARY 17, 2022

Acute cardiac injury has been a well-documented feature of infection with SARS-CoV-2, which causes COVID-19 among patients requiring hospitalization. It is well understood that patients who experience acute cardiac events or chronic uncontrolled hypertension are at a significantly increased risk of developing heart failure, for example.

Hospitals 52

Hospitals Diabetes Documentation Labelling 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Two device manufacturers received Warning Letters for QSR violations (QSR is FDA’s label for cGMP requirements applicable to medical device manufacturers). market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated. Terragene S.A., Terragene S.A., Shah, M.D.,

Documentation 59

Documentation Labelling 59

GMPSOP

JULY 31, 2023

These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results. Installation qualification verifies and documents that all critical aspects of equipment installation adhere to predetermined specifications and manufacturer’s recommendations.

Documentation 52

Documentation Dosage Labelling Data Entry 52

The Thyroid Pharmacist

JULY 29, 2022

But massive wildfire events like the ones in Colorado are both a cause and symptom of climate change. Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

AEs can be caused by using medicinal products within or outside the terms of their marketing authorisations (such as off-label therapeutic use, overdose, misuse, abuse or medication errors), as well as from occupational exposure.

Data Entry 52

Data Entry Vaccines Documentation Labelling 52