ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

JANUARY 10, 2023

The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. Four proposed data packages and submission strategies follow.

Packaging 52

Packaging FDA Communication Vaccines 52

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

Process Improvement Packaging Dosage Compounding 98

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

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

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

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

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

Packaging Communication Immunization Vaccines 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.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98