ISPE

JULY 6, 2023

This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe. An updated draft was reviewed by the EWG members and their organizations in October 2022. Some of these potential bottlenecks are discussed in detail next.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

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. 3 (2022):593–607. October 2022. 1 (2021):48.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. This is demonstrated by the rise from $1.05 billion US in 2021 to $1.9

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

DECEMBER 1, 2023

In this article, you’ll discover: The role of vitamin D within the body The link between vitamin D deficiency and thyroid conditions How to test for vitamin D deficiency Lifestyle tips and supplements to boost your vitamin D levels What is Vitamin D? Published 2022 Mar 24. Published 2018 Aug 16. BMC Geriatr. 2022;22(1):245.

Immunization 71

Immunization Dosage Documentation 71

ISPE

AUGUST 30, 2022

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. 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). Trudy Patterson. Regulatory Landscape for Raw Materials: CMC Considerations. Jacqueline E. Milne, PhD.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MAY 10, 2023

This article discusses the main SPuMoNI accomplishments. Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Horacio Gonzalez-Velez, Ph.D.

Dosage 52

Dosage Chemotherapy Documentation Labelling 52

ISPE

SEPTEMBER 8, 2023

A team of industry leaders with expertise in advancing innovative technology and products and with experience addressing regulatory divergence was assembled in late 2022. Pharmaceutical Engineering (January/February 2022). USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8.

FDA 52

FDA Dosage Documentation Communication 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

In this article, you’ll learn: Common causes behind low libido (and how the thyroid can affect this) Why conventional approaches to low libido don’t typically work in those with Hashimoto’s Natural solutions to increase low libido in both men and women What is Libido, and What Can Affect It? There are many natural solutions.

Dosage 83

Dosage Documentation FDA Labelling 83

The Thyroid Pharmacist

JANUARY 20, 2023

For the purposes of this article, I’d love to do a deep-dive focus on adaptogenic herbs, as one way to increase our body’s resilience and lower the impact of all types of chronic stress. This article features a long list of adaptogens, each of which has fascinating and unique properties.

HIV Treatment and Prevention Agents 90

HIV Treatment and Prevention Agents Immunization Compounding Dosage 90