European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 98

Documentation Pharmaceutical Manufacturing 98

European Pharmaceutical Review

FEBRUARY 22, 2023

Key features of the PDA TR 90 report The document addresses the evolution of contamination control principles towards a holistic approach. The document has 14 sections and five appendices. Ultimately, the new CSS document can help the pharmaceutical manufacturing sector to develop and implement a successful CCS.

Documentation 98

Documentation Pharmaceutical Manufacturing 98

ID Stewardship

OCTOBER 14, 2024

In this article a pharmacist with experience in writing and publishing provides 5 quick tips for pharmacy residents preparing manuscripts Authored By: Timothy P. BCPS, BCIDP Article Posted October 2024, First Released in the June 2024 IDstewardship Newsletter Tip 1: Start by picking an article type and journal The article type (e.g.,

Documentation 52

Documentation Communication 52

Pharma Leaders

MARCH 30, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 1, 2022

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

GMPSOP

AUGUST 8, 2023

Transferring Analytical Test Methods in GLP Laboratories Pharmaceuticals quality assurance & validation procedures GMPSOP Transferring Analytical Test Methods in GLP Laboratories The purpose of this article is to establish a documented process for the transfer of analytical methodology. Additional documents included each month.

Documentation 40

Documentation 40

Drug Channels

OCTOBER 3, 2024

The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing , not declining. Click here to see our original post from May 2024.

Documentation 52

Documentation 52

pharmaphorum

MAY 25, 2022

Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. The codes still apply. End of the host country. Follow the path of most resistance.

Documentation 105

Documentation Communication Pharmaceutical Manufacturing Labelling 105

ALiEM - Pharm Pearls

APRIL 5, 2023

Does this come at the expense of your documentation? What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I usually text them if it’s after shift, or talk to them on shift about their documentation. What is your favorite book or article on teaching? Definitely.

Documentation 130

Documentation Hospitals 130

Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Express Pharma

JULY 11, 2024

It also streamlines creative and video transformation while effectively engaging healthcare professionals (HCPs), patients and payers Future-ready medical content value chain: Generative AI capabilities are revolutionising the medical content value chain.

Documentation 105

Documentation 105

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

Documentation 59

Documentation Customer Service Health and Personal Care Stores Communication 59

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

GMPSOP

MAY 31, 2024

This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. – General guidance for validation document format. 12 or 24 months). .

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

ID Stewardship

OCTOBER 28, 2022

In this article a PGY2 Infectious Diseases Pharmacy Resident discusses social media as a resource for pharmacy residency recruitment, providing insights for both programs and candidates. . Article Posted 28 October 2022. While I strongly recommend reading the article, below are a few of the key takeaways. Authored by: Hunter O.

Documentation 98

Documentation 98

Pharmacy Joe

OCTOBER 2, 2024

A recent review article published in AJHP detailed the role of toxin inhibition to treat C. Clindamycin is given a strong recommendation by the IDSA to be added to penicillin for treatment of documented group A streptococcal necrotizing fasciitis. diff, Staph aureus, and Strep infections.

Inpatient 95

Inpatient Documentation 95

European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety. Register your details to read more The post How ready are you?

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

ALiEM - Pharm Pearls

MARCH 8, 2023

Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. What is your favorite book or article on teaching?

Documentation 147

Documentation Hospitals 147

European Pharmaceutical Review

DECEMBER 21, 2022

Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation. This article proposes a tentative approach for a minimum standard requirement for the WGS and bioinformatics analysis of LBPs. Download and read more now… .

Documentation 111

Documentation 111

pharmaphorum

JULY 14, 2022

Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Full list: [link].

Documentation 52

Documentation Vaccines 52

Pharmacy Joe

APRIL 26, 2023

In this episode, I’ll discuss an article about IV push piperacillin-tazobactam. Subscribe on iTunes , Android , or Stitcher Article Safety and tolerability of i.v. There were no infusion-related reactions including phlebitis or IV site reactions that were documented. Episode 812: Can You IV Push Piperacillin/Tazobactam?

Inpatient 105

Inpatient Documentation 105

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111

Dosage Inpatient Packaging Documentation 111

GMPSOP

JULY 23, 2023

If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. Installation qualification verifies and documents that all critical aspects of equipment installation adhere to predetermined specifications and manufacturer’s recommendations.

Documentation 52

Documentation Method Validation Packaging Labelling 52

Pharma Leaders

JUNE 27, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

JUNE 22, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 10, 2023

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

Documentation 98

Documentation 98

Pharma Leaders

MAY 19, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

MAY 17, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Diabetes 52

Diabetes Documentation 52

Pharma Leaders

MAY 12, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Drug Development 52

Drug Development Documentation 52

Pharma Leaders

MAY 11, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

MAY 9, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

MAY 8, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

MAY 5, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

MAY 3, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

MAY 1, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

APRIL 18, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Pharma Leaders

APRIL 14, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52