European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

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European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. Work has already begun with the ongoing public consultation on the AI reflection paper, open until the end of 2023. The plan was prepared by the Big Data Steering Group (BDSG), a joint initiative between HMA and EMA.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Labelling Packaging Documentation 45

Pharmaceutical Technology

MAY 17, 2023

Marketing Packages Taking part in the Excellence Awards offer your company many benefits including being able to tell the market, new and prospective clients about your achievement. For full details on the benefits, the scale of our audience and the marketing packages on offer please download the RESEARCH GUIDE.

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Packaging Documentation 52

European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. The PFAS regulatory challenge As a result, in the EU, a joint PFAS Restriction Proposal under REACH was submitted in 2023, aiming for a full ban on all PFAS by 2028/2030.

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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.

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Pharmaceutical Manufacturing Packaging Documentation 78

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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Quality Matters

NOVEMBER 27, 2023

While the FDA has not yet received reports of eye infections associated with these 29 products, the agency published a draft guidance in October 2023 titled “ Quality Considerations for Topical Ophthalmic Drug Products ,” marking the first instance of the FDA providing specific guidance for this product category.

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Express Pharma

MARCH 16, 2025

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Regulatory bodies in the U.S. Finally, reshoring and localised production emerged as key strategies for improving supply chain resilience.

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Express Pharma

SEPTEMBER 19, 2024

Following a successful edition in 2023, analytica Anacon India and India Lab Expo along with Pharma Pro&Pack Expo are set to make their mark in Hyderabad, the pharma hub of India, from September 26-28. This year’s event will be the largest edition to date, featuring over 500+ technology suppliers from 14+ countries.

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Packaging Documentation 105

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. References European Commission, (26 April 2023). European Commission, (28 June 2023) “Access to essential services: key challenges for the most vulnerable – report” Euractiv (26 September 2023). Euractiv (6 October 2023).

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Packaging Documentation Communication Pharmaceutical Companies 98

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Documentation Packaging Communication Customer Service 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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Labelling Packaging Documentation 59

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

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Documentation Packaging Method Validation Process Improvement 52

Big Molecule Watch

JANUARY 5, 2024

The proposed schedule also provides dates for document discovery and depositions. The Complaint identifies the case as related to Regeneron’s prior pending aflibercept BPCIA case against Samsung, filed on November 22, 2023. Three utility patents and five design patents alleged to be infringed by SB15 packaging and syringe cap: U.S.

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Packaging Documentation Biosimilars 49

GMPSOP

JUNE 28, 2024

Additional documents included each month. In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. Packaging/labeling/Misbranding: 41 warnings vi. Additional documents included each month. All written and updated by GMP experts.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

Pharmaceutical Technology

APRIL 14, 2023

Although the organisation previously shared a draft version of the report in February, the revised document features new details on the drugs’ potential fair pricing. Obeticholic acid will be in the spotlight when an approval package for its use in NASH will be discussed at a Gastrointestinal Drugs Advisory Committee meeting on May 19.

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Packaging Documentation 52

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., josh.levin@usp.org Thu, 08/03/2023 - 15:43 Supply Chain

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Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 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.

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Documentation Method Validation Packaging Data Entry 52

RX Note

JUNE 5, 2023

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

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GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

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Documentation Method Validation Packaging Labelling 52

epicur

AUGUST 8, 2023

It was a busy first six months of 2023 for veterinary professionals and practices, and the rest of the year isn’t likely to slow down. The system lists what you can order for office stock and will provide the documentation necessary for patient-specific orders if the guidance requires it. Watch it On-Demand 2.

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Compounding Documentation Compounding Pharmacies Packaging 52

Integra X Files

DECEMBER 19, 2022

The document also requires plans to provide a transition period for non-formulary drugs to ensure beneficiaries have continuous access to required medications. In its LTC Guidance Document, CMS instructs plans to make efforts to reach out to LTC pharmacies to advise them of network pharmacy participation.

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Nursing Homes Documentation Dosage Packaging 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

European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. Sustainable pharma packaging: breaking down the barriers to adoption Over two years it resulted in approximately 52,000 inhalers being returned, equating to approximately 305 tonnes of CO 2. 2023; 11 (17), 6510-6522. 2023; 33:5. 2023; 33(1): 24. Cited 2024August].

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Packaging Community Pharmacies Documentation Pharmaceutical Companies 52

GMPSOP

DECEMBER 24, 2023

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. These rules are globally agreed to, but local differences remain. All written and updated by GMP experts.

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Documentation Method Validation Packaging Data Entry 40

GMPSOP

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer? Additional documents included each month. Subscribe b.

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Documentation Dosage Communication Method Validation 52

National Association of Boards of Pharmacy

JULY 19, 2024

In recent weeks, FDA has also made it clear that they do not intend to extend the 1 year Stabilization Period that was announced in August 2023. 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.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Packaging Documentation Labelling Communication 59

Quality Matters

NOVEMBER 11, 2022

FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers. Contaminants can come from a drug substance, excipients (a drug’s inactive ingredients), solvents or water used in the process, product degradation during storage, or even in a product’s packaging.

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Packaging Documentation Compounding Diabetes 52

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Proxsys Rx

APRIL 19, 2024

Between late 2019 and the end of 2023, ProxsysRx’s 340B Support program went from Zero to more than $500 million in savings generated for the hospitals and health systems we serve. What we’ve learned. What it means for your 340B program. Nevertheless, notes Chance, “There’s a lot going on in the regulatory area at the state level.”

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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.

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Packaging Health and Personal Care Stores Labelling Documentation 40

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. Analytical Validation (ICH, 2023).

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Dosage Drug Development Documentation Biosimilars 52

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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