pharmaphorum

JUNE 10, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry.

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FDA Law Blog: Biosimilars

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. On March 20-21, Counsel John W.M.

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Express Pharma

DECEMBER 11, 2024

The All India Pharmaceutical Association Consortium (AIPAC) is set to launch its maiden programme, aimed at empowering pharmaceutical professionals, particularly from MSMEs (Micro, Small & Medium Enterprises), to foster skill development and scientific excellence in the pharmaceutical sector. how did it evolved?

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Nursing Homes Pharmaceutical Manufacturing Department of Veterans Affairs Dosage 97

pharmaphorum

DECEMBER 16, 2022

There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations. There is hope for greater sharing of data in the early stages of a potential pandemic event. Reacting faster.

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European Pharmaceutical Review

OCTOBER 20, 2022

Annex 1 states that “at least one representative sample is included every day that the water is used for manufacturing processes” Another important aspect of grab sampling is the frequency, which is up to the pharmaceutical company to determine. Inspection Technical Guide – Water for Pharmaceutical Use.

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pharmaphorum

AUGUST 25, 2020

Anyone in the UK who has any concerns about the activities of any pharmaceutical company can raise them with the PMCPA and be confident that it will be investigated under the auspices of a memorandum of understanding with the MHRA, backed up by UK law. That has contributed to improving the perception of the industry and of HCPs.

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Viseven

SEPTEMBER 14, 2023

Unexpected geographic factors Many pharmaceutical companies relying on global markets for drug materials are particularly vulnerable to shifting geopolitical situations. For instance, depending on sources in tariff-affected countries can substantially increase a pharma company’s operational expenses.

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GMPSOP

MARCH 8, 2024

Out of trend results What is the origin of out of specification events? In the early 1990s, the Food and Drug Administration (FDA) inspected a major generic manufacturer in the US and identified concerns with failing test results. The manufacturer challenged the FDA’s view, ending in the US District Court.

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GMPSOP

JUNE 28, 2024

Deviations are unusual or unexplained events that can potentially impact product quality, system integrity, or personal safety. The fundamental difference between a planned and unplanned deviation is that the planned deviation is raised intentionally to improve a system, while the unplanned deviations are unexpected events or incidents.

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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. Sometimes, pharmaceutical manufacturers employ surface profilometry to assess the roughness of stainless-steel equipment.

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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. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process. Checkout sample preview s.

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PharmaShots

FEBRUARY 27, 2023

The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.

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Pharma Marketing Network

JUNE 11, 2020

So whether you’re an advertiser or an event coordinator or a supplier in the industry, most of them have pretty active blogs. And, you know, in just a couple of weeks since we relaunched, we had about 50, some pharmaceutical companies visiting. Don Langsdorf (EHS): 141 different pharma companies from around the world.

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GMPSOP

JULY 31, 2023

The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

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GMPSOP

MARCH 30, 2024

” You can play with a simple Run chart and Control chart calculator and learn how to determine out-of-specification and out-of-trend events. If no action is taken, the manufacturing process should not be used. Production control chart What is reconciliation in pharmaceuticals? Additional documents included each month.

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GMPSOP

APRIL 3, 2024

Repacking in a pharmaceutical warehouse Some warehouses in pharmaceutical manufacturing may decide to repack larger containers of raw materials into smaller order quantities. – Ensure an action plan exists in the event temperatures become compromised. – Demonstrate performance in the event of a power failure.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Moreover, US Pharmacopeia issued the first-ever Medicine Supply Map to find and quantify risks in upstream pharmaceutical supply chains across the country.

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Pharmaceutical Technology

DECEMBER 19, 2022

While the ripple effect of such an event is expected across sectors, in the pharmaceutical arena, small and mid-sized enterprises (SMEs) are predicted to be heavily impacted as the economic downturn affects plans to raise capital, amongst other things. JP Morgan predicts that the US unemployment rate could rise to 4.3%

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Drug Patent Watch

DECEMBER 17, 2024

The Evolving Role of CDMOs in the Pharmaceutical Industry Gone are the days when CDMOs were mere service providers. Today, they’re strategic partners in drug development and manufacturing, offering end-to-end solutions that can make or break a pharmaceutical company’s success.

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