ISPE

SEPTEMBER 21, 2023

Gorton 21 September 2023 PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ ™ and Annex 1 Conference couldn’t be better. What Will Be Most Valuable to Attendees? The 2023 ISPE Pharma 4.0™

Documentation 98

Documentation FDA 98

ISPE

AUGUST 30, 2023

™ Community of Practice (CoP) has been instrumental in the development and issuance of guidance on the use and implementation of computerized systems in the life sciences industry. Various case studies will be presented around formality, subjectivity, decision-making, and product availability. The Pharma 4.0™ Maturity Assessment.

Documentation 98

Documentation Vaccines 98

Viseven

JANUARY 13, 2023

Evaluation of drug efficiency on a dedicated market is a complex process that requires HEOR experts to measure multiple indicators to understand the actual market value of the product. Without such an assessment, it would be too risky to launch new products into development or even enter a new market. What is HEOR Data?

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Dosage Documentation 40

ISPE

MARCH 23, 2023

This blog post also seeks to provide discussion and guidance on some other topics related to “true copy” practices as below: The correct application of second person verification in the true copy process How to compliantly destroy original copies after verification of true copy. filling in a paper-based batch record or analytical result).

Documentation 98

Documentation FDA 98

ISPE

MAY 25, 2023

It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality proposals. That is why DT is not just about implementing smart technology, but rather a shift in our quality mindset and ways of working.

FDA 96

FDA 96

European Pharmaceutical Review

FEBRUARY 23, 2023

Despite this overlap, this article addresses the main challenges for industry and firms, and those for pharmaceutical microbiologists, separately, focusing on some of the difficult and often overlooked hurdles relating to quality assurance (QA) and quality control (QC) of licensed and marketed pharmaceutical drug products.

Dosage 92

Dosage Vaccines 92

Pharmaceutical Technology

OCTOBER 14, 2022

Powder processing research and development (R&D) has its challenges, with experienced scientists and students alike coming across hurdles even when they have the best equipment. With this compaction simulation equipment, scientists can achieve in-depth material characterisation and robust formulation development.

Communication 52

Communication 52