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

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). September 2006. www.fda.gov/media/71023/download 50 Yu, L. AAPS Journal 16, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. 1 June 2006. 16 8 Medicines Agency.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52