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 96

Adverse Reactions Documentation Medical Schools Packaging 96

Pharma Marketing Network

MAY 9, 2025

This article uncovers the hidden elements of market access success, revealing what it takes to move from FDA approval to formulary inclusion, provider buy-in, and patient adoption. A value document submitted to payers outlining clinical data, economic models, and patient impact to support formulary inclusion. What is an AMCP dossier?

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Packaging Documentation Communication 52

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. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020).

Packaging 98

Packaging Documentation Communication Pharmaceutical Companies 98

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

GMPSOP

OCTOBER 26, 2022

According to cGMP, validation in pharmaceutical industry can be defined as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” Additional documents included each month.

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Documentation Method Validation Packaging Pharmaceutical Companies 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). .

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Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

SEPTEMBER 22, 2022

Acceptable Quality Limit is used to make an informed decision whether to accept or reject an incoming packaging components lot by assessing the lot size and types of defects found during a pre-determined level of inspection. Additional documents included each month. All written and updated by GMP experts. Checkout sample preview s.

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Packaging Documentation Labelling 52

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

Pharmaceutical Manufacturing 78

Pharmaceutical Manufacturing Packaging Documentation 78

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.

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Documentation Method Validation Packaging Labelling 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.

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Dosage Inpatient Packaging Documentation 52

GMPSOP

FEBRUARY 15, 2024

This article is to help all personnel maintain a state of alertness to make sure that the plant housekeeping is always kept at the peak of efficiency. They should place all discarded cardboard, paper, and corrugation from the Packaging Dept. Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines.

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Documentation Labelling Compounding Packaging 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. You must document all sampling procedures and plans in use.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 28, 2024

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. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

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.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

MARCH 17, 2023

Table of Contents If you are looking for literary help to write an actionable procedure on corrective and preventive action for your workplace or school, this article will be a good place to start. Additional documents included each month. The entire unused packaging lot which was quarantined was returned to the supplier.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

JUNE 16, 2023

In this article, we will briefly discuss some essential elements of analytical method transfer, industry best practices, method transfer strategies, method transfer process workflow, and necessary considerations for a seamless transition. Additional documents included each month. All written and updated by GMP experts. Subscribe b.

Documentation 52

Documentation Dosage Communication Method Validation 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.

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Documentation Method Validation Packaging Data Entry 40

National Association of Boards of Pharmacy

JULY 19, 2024

Gathering transaction information for recalls at the package level. Document the date and the number of relevant full-time equivalent employees (FTEs) for each parent company pharmacy. Conducting product verifications for suspect and illegitimate products. FDA recommends this be based on the November 2024 expected employee filings.

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Pharmacy Technician Documentation Communication Packaging 45

GMPSOP

DECEMBER 6, 2024

This article explores how to prevent chemical spills, respond to and manage spills, dispose of contaminated materials, report spills, and assign responsibilities to the spill response team. Additional documents included each month. Additional documents included each month. Additional documents included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

Proxsys Rx

APRIL 19, 2024

Two potential 340B developments for 2024 In an article dated January 5, the subscriber-only website 340B Report projected that “In 2024, congressional gridlock and election year dynamics will likely slow momentum on any comprehensive 340B program reform package.” If you’d like to read the ruling’s additional 19,209 words, Click Here.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

GMPSOP

DECEMBER 10, 2023

Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates, registration numbers, barcodes, etc. Commonly used packaging materials are cartons, inserts, leaflets, printed foil, etc.

Packaging 40

Packaging Health and Personal Care Stores Labelling Documentation 40

Express Pharma

JUNE 23, 2025

Most projects fail not in the lab, but in study design, regulatory interpretation, and documentation. This article explores why E&L studies go wrong and how to build a submission-ready package from protocol to final report. The reason?

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Packaging Dosage Documentation Biosimilars 65

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

GMPSOP

MARCH 3, 2024

Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. Additional documents included each month. What are the examples of cross contamination in pharmaceutical industry?

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging 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.

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Documentation Packaging Pharmaceutical Manufacturing Compounding 98

GMPSOP

NOVEMBER 15, 2024

Stability testing ensures that the manufactured products remain safe, pure, and effective throughout their shelf life if they are kept in specified packaging and under environmental conditions. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Checkout sample preview s.

Packaging 59

Packaging Dosage Documentation Labelling 59

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Pluta Nishant B.

Compounding 52

Compounding Dosage Labelling Drug Development 52

pharmaphorum

JANUARY 18, 2022

Primary Packaging material designers. Secondary packagers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Overview of the workshop: The workshop is aimed to provide an introduction to the key elements of the Medical Device Regulation that Companies affected by article 117 need to consider.

Packaging 52

Packaging Documentation Drug Development Vaccines 52

GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

European Pharmaceutical Review

APRIL 14, 2025

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). That proposed Directive contains a similar regulatory framework for decentralised manufacturing (see prospective Articles 142-153). But the UK framework will arrive first.

Hospitals 52

Hospitals Documentation Packaging Communication 52

GMPSOP

MAY 17, 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 52

Documentation Packaging Pharmaceutical Manufacturing Compounding 52

The Thyroid Pharmacist

JULY 29, 2022

In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Check out my article on mold toxicity to learn more about reducing mold in your home. (I How airborne toxins can affect the thyroid.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

Quality Matters

JUNE 14, 2023

Beyond addressing proper documentation, storage, and transportation, GDPs incorporate appropriate mitigation strategies to control the foreseeable risks. An expanded rationale for the revision was included in a related Stimuli article. Also open for public comments is new General Chapter Qualification of Storage Areas.

Dosage 52

Dosage Packaging Documentation Hospitals 52

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. The Court noted that many of the documents excluded by the FC were not confidential and could be disclosed, and remitted the matter for redetermination on several issues (see here ). Introduction.

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Documentation Labelling Vaccines Packaging 52

GMPSOP

JULY 31, 2023

In this article, we will explore what operational qualification entails, its importance, and FDA requirements. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

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Documentation Dosage Labelling Data Entry 52

Board Vitals - Pharmacist

NOVEMBER 8, 2022

Step 4: Applying and integrating the evidence “ As clinicians, we need to be confident in our decision-making,” writes Shannon Casey in a recent Medpage article. Once clinicians have translated their research and skills into practice, they need to learn how to measure, quantify and document the outcomes data.

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Medical Schools Hospitals Inpatient Packaging 52

GMPSOP

AUGUST 28, 2023

This article is crafted with real-life experiences and insights to help you fine-tune your material handling processes, optimize efficiency, and ensure compliance while working at the warehouse. 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