ISPE

SEPTEMBER 8, 2023

Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER I don’t think many of us would want to subscribe to the concept of second air as appropriate. Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER Annex 1 is aligned and in harmony with the FDA’s guidance for aseptic processing from 2004.

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European Pharmaceutical Review

AUGUST 17, 2022

Steve Brooks, Manufacturing Lead at the AMR Industry Alliance (Advisor to the Alliance): AMR is multifaceted; there are many potential causes, including environmental ones. We have four focus areas for projects: access, appropriate use, manufacturing, and research and science. It is a proactive step by industry.

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ISPE

APRIL 12, 2023

Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. Digitizing and automating processes is paramount to avoiding manufacturing and regulatory delays that jeopardize patient health. The continued use of paper validation in a Pharma 4.0

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ISPE

NOVEMBER 10, 2022

Later in my career, I started to realize and apply myself to the many gaps that exist between the initial R&D of treatments and how to scale them in manufacturing to bring these products to patients. I focus my work to improve the required methods, equipment, and systems for our emerging industry to scale to meet our vision.

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ISPE

OCTOBER 27, 2022

You will get answers to the following questions: How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time? What needs to be done to properly clean equipment used in these processes?

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ISPE

OCTOBER 28, 2022

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. The Road to Advanced Manufacturing.

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ISPE

MAY 25, 2023

™ is the concept of ‘Plug and Produce’ connectivity, with a dedicated team on this topic led by Wolfgang Winter, and this part of the session will go on to provide practical insights on Pharma 4.0™ Predictive modeling is a key attribute to ensure operational excellence and a robust manufacturing process. The Pharma 4.0™

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ISPE

JULY 19, 2023

™ is now probably the most important industrial approach or pharma manufacturing, particularly for sterile and aseptic products. SmartFacturing Michelangelo Canzoneri, Global Head of Group Smart Manufacturing at Merck KGaA, Darmstadt, Germany, opened his keynote “SmartFacturing” by asking how we should manage the new normal.

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European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

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ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. This article summarizes those trends and ponders next steps in the adoption of continuous manufacturing of biologics.

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European Pharmaceutical Review

FEBRUARY 23, 2023

Given the widely reported challenges of validation and qualification of microbiological methods, as well as lab compliance and keeping up with compendial amendments, I have steered away from these topics here. Edward actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing.

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ISPE

SEPTEMBER 12, 2022

Deputy Director, Office of Manufacturing Quality. What’s the direction you see for ATMP manufacturing regulation? What controls need to be considered when patient-specific manufacturing has multiple products and different viral vectors in the same room? 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor.

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FDA Documentation Communication 52

pharmaphorum

OCTOBER 7, 2020

Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects.

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Roots Analysis

SEPTEMBER 22, 2023

These devices are equipped with advanced features like programmable dosing, connectivity to mobile apps, and safety mechanisms to ensure accurate and controlled drug delivery. The approval is granted on the basis of scientific evidence provided by the manufacturer elucidating the safety and effectiveness of the devices.

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Hospitals Dosage Chemotherapy Insurance 40

The Physician Pharmacist

OCTOBER 19, 2023

link] Our conversation with Dr. Smith covers a wide array of topics that will resonate with aspiring medical professionals and pharmacy enthusiasts alike: Applying to Medical School as a Pharmacy Applicant : Discover the unique considerations and challenges that pharmacy applicants face when making the transition to medical school.

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Medical Schools Hospitals Patient Care Community Pharmacies 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Flame retardants began to be manufactured in consumer products in the 1960s, to address fire safety regulations. TVs, mobile phones, video equipment, scanners, printers). 8] I discuss this topic in my book, Hashimoto’s Thyroiditis: Lifestyle Interventions for Finding and Treating the Root Cause. Electronics (e.g.

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Health and Personal Care Stores Labelling Immunization Compounding 55

The Thyroid Pharmacist

JULY 29, 2022

Heavy equipment. Indoor sources include flame retardants, upholstery, flooring and manufactured wood products, cleaning agents, etc. The main sources of VOCs are adhesives, paints/varnishes, upholstery, carpeting, manufactured wood products, pesticides, cleaning agents, etc. The manufacturer should provide that info.

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ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP).

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Documentation FDA Packaging Communication 52

ISPE

MARCH 15, 2023

While the term sustainability encompasses a wide scope of goals, in examining manufacturing environmental sustainability we address reducing environmental burdens and progressing to more circular economies throughout the product and manufacturing process life cycle. Green Manufacturing for the Pharmaceutical Industry.”

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ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. HC is expected to have full implementation of ICH Q12 by late 2022.

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Documentation FDA Communication Packaging 52

ISPE

MARCH 7, 2023

Research and development, manufacturing, commercial (sales and marketing) activities, and their extended supply chains including logistics are all within this scope. It may be necessary to hire subject matter experts to develop and maintain these standards and provide technical support in this fast-moving topic area. 1 United Nations.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

Pharmaceutical Technology

MARCH 6, 2023

Under the licence deal, Novartis will gain exclusive global rights for the research, development, manufacturing, and commercialisation of the candidate for all potential indications. The new JV will primarily utilise Teijin Pharma’s drug discovery research capabilities, facilities, personnel, technologies, and equipment.

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Compounding Communication 105

Pharmaceutical Technology

JANUARY 6, 2023

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. The texture and quality of any topical formulation is critical. Simplicity matters.

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Dosage Packaging Communication 52