Pharmaceutical Technology

NOVEMBER 25, 2022

CK Life Sciences vice-president and chief scientific officer Dr Melvin Toh said: “The cooperation with XtalPi will apply XtalPi’s AI algorithm, molecular modelling and automated experiments to speed up the R&D process, improve the success rate, and increase the efficacy of tumour vaccines.”.

Vaccines 98

Vaccines Immunization Process Improvement Compounding 98

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Journal of Pharmaceutical Sciences 109 (2020):1427–1438.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

3 (2020):e2970. 16 June 2020. Organic Process Research and Development 24, no. 10 (2020):1861–75. Pharmaceutical Engineering September/October 2020. 8 June 2020. www.amgen.com/newsroom/press-releases/2020/09/lilly-and-amgen-announce-manufacturing-collaboration-for-covid-19-antibody-therapies 60 McQueen, J.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 29, 2023

July–August 2020). 2 Regulatory Binding Elements/ECs In the proposed comprehensive QOS, a summary of pharmaceutical development information along with a table that conveys the control strategy is provided. McMahon, R. Nosal, and T. Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12.” Pharmaceutical Engineering 40 no.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

July–August 2020). 2 Regulatory Binding Elements/ECs In the proposed comprehensive QOS, a summary of pharmaceutical development information along with a table that conveys the control strategy is provided. McMahon, R. Nosal, and T. Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12.” Pharmaceutical Engineering 40 no.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020. Published March 2020. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98