ISPE

SEPTEMBER 10, 2023

Connor Dennis, PhD Roger Nosal 1 September 2023 As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. WHO Expert Committee on Specifications for Pharmaceutical Preparations.” Published 2021.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 1, 2023

To minimize this exposure a fully automatized line should be installed in a smart factory EtO sterilization plant, and this will be covered in the following article. Once submitted, you will receive a link via the email you provided to download the white paper. Download White Paper To download this white paper, complete the form below.

Communication 59

Communication 59

ISPE

OCTOBER 1, 2022

Once submitted, you will receive a link via the email you provided to download the white paper. ISPE will store your information in a secure environment and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you. 1 October 2022. Download White Paper.

Communication 52

Communication 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. In an attempt to address these challenges, in 2019 the ICH endorsed ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (and Annexes).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JANUARY 10, 2023

This article presents a proposed regulatory strategy to help alleviate supply risks for approved therapeutics. The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review.

Packaging 52

Packaging FDA Communication Vaccines 52

ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

OCTOBER 28, 2022

This article shows how automation engineers and client validation personnel were successful in navigating COVID-19 restrictions and overcoming previously held preconceptions about remote testing to meet end-user and regulatory requirements. In the pharmaceutical sector, the ISPE Good Automated Manufacturing Practice (GAMP) 1.

Communication 52

Communication Documentation FDA 52

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. 2 With the pharmaceutical industry being such a major contributor to the global economy and impacting the lives of so many, 3 the industry finds itself under the spotlight of expectation to give a higher priority to sustainability initiatives.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 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 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). and the impact on supply resiliency.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Intended for the purpose of displaying, analyzing, or printing medical information about a patient. ?. information about a patient. ?. Digital health technology.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Intended for the purpose of displaying, analyzing, or printing medical information about a patient. ?. information about a patient. ?. Digital health technology.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

Among the many effects the Covid-19 pandemic has had on the pharmaceutical industry is a substantial increase in the number of AEs being reported from drug trials, due to the fast-tracked development, approval and marketing of vaccines for the SARS-CoV-2 virus. To learn more about RWS’ use of MT, please visit our website.

Data Entry 52

Data Entry Vaccines Documentation Labelling 52

Pharmaceutical Technology

JUNE 22, 2023

Presented as part of the EC’s long-awaited pharmaceutical reform in late April, the scheme aims to encourage the research of novel antimicrobials by creating a system of transferable exclusivity vouchers. Årdal previously wrote about the voucher scheme in a February 2023 article published in The Lancet.

Documentation 52

Documentation Communication 52