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

Pharma Leaders

MARCH 21, 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

MARCH 20, 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

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

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

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 100

Documentation Pharmaceutical Manufacturing 100

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 91

Documentation 91

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

ID Stewardship

MARCH 12, 2023

In this post a top 10 list of journal articles to read during an infectious diseases pharmacy rotation is provided. Articles included here are some of my favorites. Not being included in this list does not reflect a lack of quality and certainly there are many robust articles that could be added. Authored by: Timothy P.

Medication Guidelines 118

Medication Guidelines Documentation Labelling Hospitals 118

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

European Pharmaceutical Review

JULY 7, 2022

In an article published in the Journal of GXP Compliance , Moldenhauer explained what can be learned from the observations for a vaccine production facility published in a redacted FDA 483 Report as an example. One cannot just assume that a repair has no effect on the production,” with the rationale for change and impact decision documented.

Documentation 96

Documentation Vaccines 96

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

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

National Association of Boards of Pharmacy

APRIL 3, 2024

Prepare the records or documents that will be needed for your on-site visit and develop a plan to access them efficiently. In this article, we will discuss each of the above steps and provide detailed information to help your organization prepare for an inspection, survey, or review. Conduct a mock inspection or survey.

Documentation 45

Documentation 45

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 101

Documentation 101

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 95

Documentation 95

GMPSOP

NOVEMBER 19, 2023

The scope of this article applies to all regulated medicinal products manufactured at a GMP site that undergo annual product quality review. The content of this article does not supersede or replace any local or international regulatory requirements. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

pharmaphorum

JUNE 3, 2021

This article appears in our digital magazine Deep Dive: Market Access 2021. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Leela Barham takes stock. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 98

Documentation 98

RX Note

APRIL 21, 2023

Insert Page Number To start inserting page number, you can either double click header or footer section of the document, a new tab of "Header & Footer". You may tick on " Different First Page" if the document includes cover page. This will make your article writing much easier and smoother.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 17, 2023

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending.

Documentation 84

Documentation 84

The Honest Apothecary

MAY 5, 2023

In a Forbes article on this topic the author observers “Day-to-day failure to follow through is costing managers long-term credibility with their employees. Fixing Bad Follow-Through The first step to fixing poor follow-through as a leader is to, beginning today, document everything you are expected to do in writing. That is it.

Documentation 100

Documentation 100

European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

Adverse Reactions 74

Adverse Reactions Documentation Medical Schools Packaging 74

Pharma in Brief

APRIL 26, 2021

The FCA also continues to encourage Parties to file their non-confidential documents by email, [2] and to refer to the e-filing guide, Requirements and Recommendations For Filing Electronic Court Documents in the Federal Court of Appeal. Guerreiro and David Yi for their help in drafting this article. [1]

Documentation 52

Documentation 52

RX Note

MARCH 28, 2024

Under Regulation 16 , all registers, records, book, prescriptions, signed orders and other documents shall be kept for a period of 2 years from the data on which the last entry is made.

Documentation 52

Documentation Drug Storage Compounding 52

GMPSOP

DECEMBER 24, 2023

This article will focus on G(C)LP due to its significance in everyday laboratory operations. Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

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 52

Dosage Inpatient Packaging Documentation 52

ALiEM - Pharm Pearls

MARCH 22, 2023

” What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I like to open an email while I sign my charts and take notes to send to learners; particularly if I notice a pattern of difficulty with documentation. Do you feel departmental flow and metrics adversely affect teaching?

Hospitals 130

Hospitals Documentation Medical Schools 130

Pharmaceutical Technology

JULY 19, 2022

In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, 19 (1.3%) referred to cloud computing.

Omnicell 98

Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 98

Fuld & Company Blog

MARCH 28, 2024

” We went through a massive pile of over 5,000 documents, including scientific studies, patents, blog posts, news articles, and information from company websites, to come up with solid advice for our client.

Documentation 52

Documentation 52

GMPSOP

FEBRUARY 28, 2024

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.

Documentation 98

Documentation Packaging Pharmaceutical Manufacturing Compounding 98

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020). Article 63 Euractiv (26 September 2023). Article 63 PGEU (2023). European Commission (26 April 2023).

Packaging 82

Packaging Documentation Communication Pharmaceutical Companies 82

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. The GAMP 5 Second Edition includes: Six completely new appendices.

Documentation 85

Documentation Pharmaceutical Companies Pharmaceutical Companies 85

pharmaphorum

SEPTEMBER 29, 2022

The FDA has issued multiple guidance documents over the past several years in an attempt to illustrate what is and what is not a medical device, what is subject to enforcement discretion, and what the FDA actively regulates. More information about this process may be found in FDA’s 513(g) Guidance Document. not a medical device, ii.

Documentation 104

Documentation 104

Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

Documentation 52

Documentation Compounding Pharmaceutical Manufacturing 52

pharmaphorum

JANUARY 28, 2022

The messages were requested via a freedom if information request by journalist Alexander Fanta of netzpolitik.org, who was following up an article in the New York Times last year which suggested “personal diplomacy” had played a big part in the EU’s order for 1.8 billion doses of Pfizer and BioNTech’s vaccine.

Vaccines 64

Vaccines Documentation 64

Fuld & Company Blog

NOVEMBER 13, 2023

Each article provides a concise, strategic viewpoint designed to inform and guide your business decisions. Practicing War Games at UC Irvine’s business school AI is transforming the private equity deal lifecycle, from document review to data analysis.

Documentation 52

Documentation 52