ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

Documentation 52

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ISPE

OCTOBER 27, 2022

As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging. You may unsubscribe from these ISPE communications at any time. Getting More from Facilities. Cell & Gene Therapy. Unlock Access to Member-Only Content.

Process Improvement 98

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ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

MARCH 6, 2023

solvent selection, inhaler propellant replacement, and packaging design) to employee travel and commute policy (e.g., recycled content in packaging, reduction of packaging weights). You may unsubscribe from these ISPE communications at any time. This could range from product and process design decisions (e.g.,

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

MARCH 7, 2023

Representatives from R&D, manufacturing and supply, and commercial should all be included at the top-level forum, along with the main functions needed for delivery such as the sustainability group, engineering, procurement, legal, and corporate communications. Communicating keynote successes will help encourage engagement and support.

Health and Personal Care Stores 52

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ISPE

SEPTEMBER 11, 2023

In a 2009 Pharmaceutical Engineering® magazine article, Mason, McGarvey, and Spearman reported air speed measurements and air flow patterns in conventional cleanrooms with obstacles in the room, which caused obstruction of the unidirectional air flow. x, a free and open-source computational fluid dynamics (CFD) software package.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 27, 2022

Different engineering disciplines, such as architectural and process piping, may use different software packages, which can then be combined into a single coordinated model. You may unsubscribe from these ISPE communications at any time. Accessed 11 August 2022. Unlock Access to Member-Only Content. Company Name.

Packaging 52

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. You may unsubscribe from these ISPE communications at any time. Common Technical Document [CTD] sections). Regulatory.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. You may unsubscribe from these ISPE communications at any time. Company Name.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 10, 2023

In these countries, a secondary packaging site change or an active pharmaceutical ingredient (API) manufacturing site addition triggers a new submission equivalent to that required for approval of a generic drug or a line extension, whereas these site changes may be filed as a notification in the US and EU. Commission Regulation (EC) No.

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