ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2022. 7 March 2023. Regulatory Focus.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Although they have been historically overlooked as a key element, raw materials are a critical component at every stage of the drug manufacturing processes. Burke, PhD. 1 September 2022.

Documentation 52

Documentation FDA Packaging Communication 52