ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published June 2008. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 12, 2022

And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. In the event that first air is inadvertently interrupted, it should lead to a documented evaluation of the contamination hazard posed to the aseptic operation. It can be in production or quality control.

FDA 52

FDA Documentation 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

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. Published 2008. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns. 5 European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. Published June 2008. 22 June 2023. EMA/321483/2020.

FDA 52

FDA Dosage Documentation Communication 52

ISPE

MARCH 7, 2023

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published June 2008. Press Release. 30 November 2022. link] 6 European Medicines Agency. Committee for Medicinal Products for Human Use. 27 January 2022.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 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