ISPE

SEPTEMBER 11, 2023

Herein, DM refers to a manufacturing model in which many units or facilities are disseminated across different geographical areas 6 , 7 DM facilities may produce similar or identical products under a unified pharmaceutical quality system (PQS) or operate as independent units with different outputs.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

NOVEMBER 30, 2022

A key challenge in life sciences is the detrimental effect of unplanned downtime and lost batches due to unanticipated equipment failure. PPM uses machine learning algorithms to detect failure or anomaly patterns across equipment. Making Maintenance a True Asset in Pharma Manufacturing Through Digitalization. Monica Lomeli.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

APRIL 12, 2023

Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. Additionally, validating new equipment, processes, and methods with paper would have delayed opening and amplified the potential for costly manual errors. 1 Weeks, L.

Documentation 98

Documentation FDA 98

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

JULY 7, 2023

4 , 5 Other challenges reflect the cautious nature of pharmaceutical manufacturing, like risk aversion and regulatory considerations. 4 , 5 Other challenges reflect the cautious nature of pharmaceutical manufacturing, like risk aversion and regulatory considerations. Chemical Engineering Science (2021): 231. Bi, and A.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 6, 2023

Sustainability Definitions for the Pharmaceutical Industry Trudy Patterson Mon, 03/06/2023 - 10:26 Features March / April 2023 Sustainability Definitions for the Pharmaceutical Industry William G. Green Manufacturing for the Pharmaceutical Industry.” while meeting patient needs as a primary goal. 1 European Commission.

Communication 52

Communication Patient Care 52

ISPE

NOVEMBER 10, 2022

Shin Kawamata, Director at the Research and Development Center for Cell Therapy at FBRI in Kobe, Japan, is a researcher in the field of cell therapy and led the setup of the first commercial GMP facility in Japan. Pharmaceutical Engineering® recently spoke with Kawamata about his work. FBRI at Kobe.He

Documentation 98

Documentation Compounding Hospitals Immunization 98

ISPE

MARCH 7, 2023

Melton, PhD 1 March 2023 The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. 1 , 2 The effect to the pharmaceutical industry spans its end-to-end activities, including the residual impact of used and unused medicines on the environment.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

NOVEMBER 1, 2022

Zipp spoke next to welcome attendees, who she encouraged to make the most of the meeting through sessions and meeting with colleagues, noting that many key topics are being covered. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Quality, Defined.

FDA 98

FDA Insurance Chemotherapy Documentation 98

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. Highlights of the discussion follow. Collaboration.

Vaccines 52

Vaccines FDA Immunization 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Such changes can include increasing batch sizes, adding manufacturing facilities, creating new product presentations, and updating analytical methods. Michael Abernathy. 1 September 2022.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 12, 2022

Director, Office of Pharmaceutical Quality Operations. I'd like to concur that data integrity issues and poor data governance can be found in any sector of pharmaceutical manufacturing. Director, Office of Pharmaceutical Quality Operations. There is a lot of good engineering out there. Panel Participants. Alonza Cruse.

FDA 52

FDA Documentation Communication 52

ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. In cases where raw materials are single sourced, supplier manufacturing problems or product facility closures could result in manufacturing delays and/or stoppages. Regulatory Expectations.

Documentation 52

Documentation FDA Packaging Communication 52

Roots Analysis

SEPTEMBER 22, 2023

These significant benefits offered by wearable injectors, coupled with their rising demand in the pharmaceutical industry and healthcare sector, worldwide is likely to drive market growth during in the coming years. wearable injectors are integrated with smart technology that allows for programmable dosing schedules.

Hospitals 40

Hospitals Dosage Chemotherapy Insurance 40

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.

Dosage 52

Dosage Packaging Communication 52