ISPE

OCTOBER 27, 2022

Blow-fill-seal containers are commonly used for various dosage forms, what are the latest developments in this field? Project RiskSurve from FDA: a project to create a comprehensive site surveillance model consolidating data from different dimensions: what are the first learnings? What does KAIZEN for aseptic processing look like?

Dosage 98

Dosage Vaccines FDA Documentation 98

The FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system.

FDA 45

FDA Dosage 45

DiversifyRx

APRIL 4, 2024

Compounding laws and regulations are a patchwork of rules and guidelines created by the FDA, USP, and state boards of pharmacy. While states can create their own rules, according to FDA guidelines, semaglutide and tirzepatide can be compounding because they are on the FDA shortage list. There is no need to rush to higher doses.

Independent Pharmacies 40

Independent Pharmacies Compounding Compounding Pharmacies FDA 40

ISPE

DECEMBER 13, 2022

The opening keynote will feature Brook Higgins from the FDA and focus on the critical role of environmental monitoring and preventative steps to take for a strong sterility assurance program to reduce positive sterility tests. The conference will have a highly anticipated industry panel solely focusing on the revisions to Annex 1.

Dosage 52

Dosage FDA 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Advanced Manufacturing.”

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

Its Pharmaceutical Education & Research Center (PERC) is a US Food and Drug Administration (FDA)-registered, cGMP-compliant, single-source CRO equipped with the latest equipment and technologies, for most dosage forms, found in the pharmaceutical industry. 2 Research Triangle Park. As automation and Pharma 4.0

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. A final report will be provided as the basis for an ISPE workshop, with recommendations subsequently published in Pharmaceutical Engineering and other trade publications. 22 June 2023. link] 16 US Food and Drug Administration.

FDA 52

FDA Documentation Dosage Communication 52