ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns. Biological (Viral and Microbial) Risk Progression.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

JANUARY 8, 2023

Furthermore, these outputs can support communicating the functioning of the algorithm and how it is embedded in operational procedures in an audit situation. In this process, documentation regarding the decisions made is important to justify the model and explainability mechanism selection in an audit context.

Communication 52

Communication Documentation FDA 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. You may unsubscribe from these ISPE communications at any time.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. Leave this field blank

Documentation 52

Documentation FDA Communication 52

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 You may unsubscribe from these ISPE communications at any time. m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 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. You may unsubscribe from these ISPE communications at any time.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

MARCH 15, 2023

There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. You may unsubscribe from these ISPE communications at any time. Leave this field blank

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

SEPTEMBER 10, 2023

Existing regulatory frameworks In the 1950s and 1960s, the WHO published documents outlining how countries should set up a regulatory framework to control pharmaceuticals and ensure the safety of their subjects. You may unsubscribe from these ISPE communications at any time. The proposals are consistent with WHO GRP. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98