pharmaphorum

JULY 28, 2022

That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. The extraordinary scenario of producing vaccines for a global pandemic led to a well-documented shortage of vials, stoppers, and syringes, and finding a solution is no easy task.

FDA 108

FDA Dosage Documentation Compounding 108

The Checkup by Singlecare

OCTOBER 17, 2023

Clindamycin is available in various dosage forms, including capsules, oral solution, vaginal cream and gel, topical lotion and gel, and intravenous (IV) injections administered in a hospital setting. Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. RELATED: Can antibiotics cause diarrhea?

Vaccines 52

Vaccines Dosage Documentation FDA 52

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 97

FDA Vaccines Dosage Documentation 97

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 52

FDA Vaccines Dosage Documentation 52

ISPE

OCTOBER 27, 2022

You will get answers to the following questions: How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time? SARS CoV-2 vaccines have been formulated in lipid nanoparticles.

Dosage 98

Dosage Vaccines FDA Documentation 98

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. 16 June 2020.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). A formal change control system under the company’s pharmaceutical quality system (PQS) is required to evaluate all raw material changes, with established procedures for identification, documentation, review, and approval.

Documentation 52

Documentation FDA Packaging Communication 52