GMPSOP

JANUARY 29, 2025

Fundamental requirements of GMP compliant software The critical objectives for developing a quality management software application are to make the quality concern investigations processes faster, more reliable, accurate, secure, and permanent for future reference. – Appropriate controls over systems documentation.

Documentation 94

Documentation Process Improvement Pharmaceutical Manufacturing 94

RX Note

JUNE 15, 2025

The raw generic name itself is not used as the document key ID, since it can be lengthy and may include special characters that could lead to ID mismatches or errors in URL-based routing. NOTE: The spreadsheet should have clear headers that correspond to the fields you want to create in Firestore documents.

Documentation 40

Documentation Process Improvement 40

Syner-G

SEPTEMBER 20, 2023

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. Download The Case Study The post Process improvements and in-person monitoring help U.S. Challenge Syner-G was contracted by a U.S.

Process Improvement 40

Process Improvement Pharmaceutical Companies Pharmaceutical Companies Documentation 40

European Pharmaceutical Review

AUGUST 3, 2023

The optimised framework aims to overall, drive higher product quality and improved patient safety. Summarising recommendations and best practices for CAPA process improvement, this whitepaper uses data collected from a pilot suggested in the MDIC’s initial whitepaper that proposed the framework.

Documentation 52

Documentation Process Improvement 52

Fuld & Company Blog

SEPTEMBER 20, 2023

Streamlined document review: AI-powered platforms revolutionize document reviews by automatically categorizing and analyzing vast volumes, streamlining due diligence, and potentially improving accuracy and depth.

Documentation 52

Documentation Process Improvement 52

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. Trending will help identify product and process improvements. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

Syner-G

SEPTEMBER 15, 2023

Both processes are evolving to enhance product development and output. Upstream processing advancements encompass fed-batch processes , improved cell culture media, advanced feeding strategies, and tailored bioreactor control.

Drug Development 59

Drug Development Documentation Process Improvement Compounding 59