European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

European Pharmaceutical Review

JUNE 24, 2022

FDA briefing documents that address these reformulation strategies should include a description of the formulation design strategy that is employed to minimise the formation of NDSRIs in the drug product, including supporting manufacturing information and, at a minimum, three months of accelerated stability data demonstrating control of NDSRI.

FDA 52

FDA Documentation Compounding 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 26, 2022

EU human tissues and cells directive 2004/23/EC; 7. 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. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , The assessment may also identify perception concerns.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

NOVEMBER 30, 2022

Nik helped to create ISPE Guidance Documents and training materials including a Critical Utility GMP Compliance Training Course based off of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It. Nik has been a member of ISPE since 2004.

Documentation 52

Documentation Compounding Dosage 52

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. September 2004. September 2004. 3 , 27 Advantages POD increases manufacturing flexibility, speed, and consistency. 2 (1 May 2005).

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Health authorities have divergent classifications for changes in terms of risk to product quality and documentation/data requirements. Burke, PhD. 1 September 2022.

Documentation 52

Documentation FDA Packaging Communication 52