GMPSOP

AUGUST 14, 2023

How to perform periodic review of systems and processes in pharmaceuticals? Pharmaceuticals quality assurance & validation procedures GMPSOP How to perform periodic review of systems and processes in pharmaceuticals? No issue with product sterilization. Doesn’t it sound like an ideal world?

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Documentation Pharmaceutical Manufacturing Packaging 52

European Pharmaceutical Review

OCTOBER 6, 2023

India’s membership is “the latest step in the USP’s and PDG’s commitment to expand access to PDG quality standards by approximately 1.3 According to the PDG, in recent years it has addressed emerging drug quality issues such as the potential for impurities and reaching consensus on harmonisation of select pharmacopoeial standards.

Pharmaceutical Manufacturing 86

Pharmaceutical Manufacturing 86

European Pharmaceutical Review

APRIL 17, 2023

A report on automation in the biopharma industr y has shown that the market is projected to grow at a compound annual growth rate (CAGR) of 5.7 Factors impacting the automation in the biopharma industry market The report found that 75 percent of pharmaceutical organisations want to use automated solutions more frequently.

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Dosage Compounding 89

European Pharmaceutical Review

OCTOBER 18, 2023

Features of the new line for syringes include the latest automated systems and quality control measures, ensuring the highest levels of safety, efficiency, and product integrity. The research predicted the global aseptic fill finish market will grow at a compound annual growth rate (CAGR) of seven percent between 2023-2035.

Packaging 91

Packaging Compounding 91

GMPSOP

MAY 17, 2024

GMP cleaning and sanitation practices in pharmaceuticals Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST GMP cleaning and sanitation of pharmaceutical equipment and facilities account for almost one-third of all production activities, if not more.

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Documentation Packaging Pharmaceutical Manufacturing Compounding 52

European Pharmaceutical Review

APRIL 3, 2024

Research by Roots Analysis predicts the pharmaceutical contract manufacturing market will value $140 billion by 2030. As such, the sector is expected to grow at a compounded annual growth rate (CAGR) of 6.5 This is due to these companies looking to meet to the varied needs of pharmaceutical developers, according to the authors.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Compounding 52

European Pharmaceutical Review

JUNE 30, 2023

Demand for process analytical technology ( PAT ) is being driven by the growing adoption of automation and digitalisation in sectors such as pharmaceutical industry, a report by Market.us Between 2023 and 2032, this market is estimated to have an compound annual growth rate (CAGR) of 13.8 billion in 2032, the report suggested.

Compounding 89

Compounding 89

GMPSOP

FEBRUARY 15, 2024

Good housekeeping practices in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Good housekeeping practices include establishing cleaning procedures and schedules to ensure washrooms and toilet facilities are properly maintained. Who is responsible for housekeeping? in the compactor.

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Documentation Labelling Compounding Packaging 52

FDA Law Blog: Biosimilars

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. That leaves 60% that manufacture at least one application product. After the U.S.,

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

GMPSOP

MARCH 30, 2024

Line clearance procedure and reconciliation in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST What is line clearance? Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

European Pharmaceutical Review

MAY 3, 2023

A market report has shown that the digital biomanufacturing market is anticipated to grow at a compound annual growth rate (CAGR) of 11 percent between 2023-2035, driven largely by digital transformation. These factors have led to industry 4.0 technologies. In bioprocessing 4.0,

Compounding 89

Compounding 89

European Pharmaceutical Review

DECEMBER 15, 2022

At least one million people living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), mainly Africa, are set to benefit from Eli Lilly and Company and manufacturer EVA Pharmaceutical’s new collaboration delivering a sustainable supply of high-quality, affordable human and analogue insulin to this population.

Diabetes 75

Diabetes Packaging Communication 75

pharmaphorum

JANUARY 30, 2023

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field. Network with the industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insights.

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Documentation Drug Development 52

European Pharmaceutical Review

JULY 25, 2023

A report from Market Research Biz has illustrated that the small molecule active pharmaceutical ingredient (API) market is expected value around $284.7 A compound annual growth rate (CAGR) growth of 5.9 For example, monoclonal antibodies are gaining prevalence in the pharmaceutical market. billion by 2032. billion in 2022.

Compounding 76

Compounding Generic Medicine Drug Development Diabetes 76

pharmaphorum

SEPTEMBER 28, 2022

We are delighted to announce SAE’s 11th Annual Pharmaceutical Microbiology Europe Conference taking place in London, UK on the 16-17 January 2023. Microbiology remains an essential tool for the detection of microorganisms present in biopharmaceutical and pharmaceutical batches. Event Hashtag: #MicrobiologyEurope.

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European Pharmaceutical Review

JULY 14, 2022

Pfizer’s Hospira is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100ml Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain samples. The full details are listed below: Products.

Hospitals 88

Hospitals 88

GMPSOP

MARCH 20, 2024

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount? Use buffer solutions with known pH values (e.g.,

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

European Pharmaceutical Review

OCTOBER 24, 2022

Adaflex, the UK’s first melatonin product for six to 17 year-olds diagnosed with ADHD and insomnia (where sleep hygiene measures have been inadequate), is now available in the UK. Its data identified half of GPs are reluctant to prescribe these products, meaning prescription responsibilities are instead placed with overstretched specialists.

Labelling 69

Labelling Pharmaceutical Companies Pharmaceutical Companies 69

European Pharmaceutical Review

JUNE 14, 2023

A report has stated that the pharmaceutical sterility testing market is expected to grow in value from $0.636 billion in 2023 to $1.0223 billion by 2032. This process is being conducted at all stages of production in the pharmaceutical and biopharmaceutical industries to help prevent product contamination, according to the report.

Compounding 52

Compounding 52

European Pharmaceutical Review

OCTOBER 1, 2022

Sharing data across borders ensures access to safe tissues and cells for human application is ethical and supply quality is adequate, said the Council in a statement. The post Sharing data on human tissue availability across EU appeared first on European Pharmaceutical Review.

Communication 89

Communication 89

European Pharmaceutical Review

JANUARY 27, 2023

It is a vital part of medical logistics, especially as the global pharmaceutical industry shifts towards the production of biopharmaceutical products, such as biologics and other temperature-sensitive molecules. The post Eli Lilly to help fund cold chain initiative appeared first on European Pharmaceutical Review.

Diabetes 84

Diabetes Communication 84

European Pharmaceutical Review

AUGUST 1, 2022

According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. The joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published a third workplan, setting actions to be delivered by 2025.

Documentation 89

Documentation 89

European Pharmaceutical Review

JUNE 28, 2023

million by 2030, growing at a compound annual growth rate (CAGR) of 5.57 Growth of the pharmaceutical and biotechnology industries, plus the need for accurate and precise analytical tools in drug development and quality control are influencing factors. percent from 2023 to 2030. What is driving the HPLC market?

Drug Development 78

Drug Development Compounding 78

GMPSOP

MARCH 3, 2024

What is cross contamination in pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST What’s cross-contamination? You should not be unfamiliar with it if you know how pharmaceutical facilities operate. What is cross contamination in pharmaceutical industry?

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

Syner-G

SEPTEMBER 28, 2023

The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must request an exemption through an Investigational New Drug (IND) application.

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Documentation Drug Development Packaging 59

European Pharmaceutical Review

OCTOBER 30, 2023

The treatment works by delivering a normal copy of the gene for production of FKRP proteins, Atamyo stated. First redosable gene therapy approved The post Gene therapy for rare muscular dystrophy presents preliminary promise appeared first on European Pharmaceutical Review.

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PharmaState Academy

MARCH 6, 2024

Name Email Phone Number Department State City 1 / 15 Which governmental body in India is responsible for issuing patents for pharmaceuticals? a) NITI Aayog b) Indian Patent Office c) Ministry of Health and Family Welfare d) Department of Pharmaceuticals The Indian Patent Office issues patents for pharmaceuticals in India.

Drug Pricing 52

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

FEBRUARY 21, 2023

According to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), there is an unmet medical need for new therapeutic approaches that might free patients from the burden of frequent infusions, or episodically at the time of a bleeding event.

Hospitals 87

Hospitals 87

pharmaphorum

OCTOBER 7, 2020

SMi Reports: An exclusive interview with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be speaking at the 3rd Annual Pharmaceutical Microbiology East Coast Conference released. María José (Pepa) Lopez Barragán is a former U.S.

Biosimilars 52

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 52

GMPSOP

FEBRUARY 10, 2024

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. Additional documents are included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

European Pharmaceutical Review

DECEMBER 14, 2023

Rates of VMS in Europe range from 56 percent up to 97 percent” These symptoms, also known as VMS, can have a disruptive impact on women’s daily activities and overall quality of life. Findings from the most recent study, SKYLIGHT 4, were presented at The North American Menopause Society Annual Meeting in October 2022.

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pharmaphorum

FEBRUARY 3, 2022

Harnessing existing methods and novel tools in microbial control to assure continuity in product quality and patient safety. SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference is taking place in Boston on April 27-28, 2022, with interactive workshops on April 26, 2022. Event Hashtag: #SMiPharmaMicroEC.

Documentation 52

Documentation Drug Development 52

Quality Matters

JUNE 26, 2023

The same potential benefits can apply for so-called “complex generics” (CGx), which are generic drug products that have a complex active ingredient, formulation, dosage form, route of delivery, or are part of a drug/device combination. This enables efficient regulatory processes, timely product reviews, and faster market access.

Dosage 52

Dosage Generic Medicine Labelling 52

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

Vaccines 93

Vaccines Pharmaceutical Manufacturing Communication Hospitals 93

Quality Matters

JANUARY 23, 2023

Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) to prioritize identification of upstream pharmaceutical supply chain risks. trillion, bipartisan government appropriations bill signed into law in December 2022.

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication 52

European Pharmaceutical Review

JUNE 28, 2022

billion by 2026, achieving a compound annual growth rate (CAGR) of 13.2 Downstream bioprocessing represents an expensive, complex and time-consuming step in the production of biopharmaceutical drugs. Advances in upstream cell culture techniques are also creating enormous bottlenecks in downstream separation and purification processes.

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Dosage Compounding Drug Development 97

pharmaphorum

AUGUST 24, 2020

SMi’s Pharmaceutical Microbiology East Coast Conference – A Virtual Conference with Remote Access Only. SMi’s 3rd Annual Pharmaceutical Microbiology Conference will no longer take place in Boston. SMi’s 3rd Annual Pharmaceutical Microbiology Conference will no longer take place in Boston. in Biology and Ph.D.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Compounding Immunity Immunization 52