European Pharmaceutical Review

APRIL 18, 2024

When measuring active pharmaceutical ingredient (API) concentrations in effluents, the limit of quantification (LoQ) of the chosen analytical method must be sensitive enough to measure anticipated effluent concentrations or risk-derived targets at the sampling point. Another important consideration is the sampling point.

Pharmaceutical Companies 82

Pharmaceutical Companies Pharmaceutical Companies 82

ISPE

MARCH 23, 2023

filling in a paper-based batch record or analytical result). Also, PICS discusses "The effort and resource assigned to data governance should be commensurate with the risk to product quality and should also be balanced with other quality resource demands." However, for higher risk data (i.e.,

Documentation 98

Documentation FDA 98

ISPE

NOVEMBER 10, 2022

We are missing data in the required formats to apply advanced analytics on significant parameters and from QC data that would aid us to continuously optimize the product and process over time. In our business, final product testing slows the shipping of products to patients who may be waiting for the treatment.

Documentation 98

Documentation Compounding Hospitals Immunization 98

ISPE

SEPTEMBER 11, 2023

Emerging Technologies and Recent Applications Agility, flexibility, and reproducibility of a biomanufacturing operating model are enabled and empowered by a variety of advanced technologies including, but not limited to, single-use technology (SUT), process analytical technology (PAT), continuous manufacturing (CM), POD, and Pharma 4.0™

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

Upon receipt, incoming raw materials should be tested against specifications that include critical attributes, analytical procedures, and acceptance criteria. The PMDA classifies such a change as a partial change application requiring prior approval if the acceptance criteria or test is registered in M1.2. Relaxing acceptance.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MAY 9, 2023

There are so many other biotech and pharma companies in this region that all the necessary departmental needs are here, including manufacturing technicians, facility mechanics, process and automation engineers, supply chain, validation specialists, and those experts in QA and QC.” 2 Research Triangle Park. 2 Research Triangle Park.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Cellular products directed towards personalised medicine have short manufacturing cycles, small batch sizes, demanding analytical methods, and short shelf lives.

Vaccines 128

Vaccines FDA Research Laboratories Documentation 128