ISPE

SEPTEMBER 11, 2023

Processes 9, no. September 2014. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. 4 (2014):771–83. 3 (2021):457. doi:10.3390/pr9030457 28 Parenteral Drug Association. PDA Technical Report No.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

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. Common Technical Document [CTD] sections).

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Documentation FDA Communication Packaging 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Green Building Council, 2014. 30 July 2014. 7 An integrative (vs. Green Manufacturing for the Pharmaceutical Industry.” 7 December 2017. Green Building Council. LEED Core Concepts Guide.

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Packaging Labelling Health Compliance Process Improvement 52