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

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

MARCH 17, 2023

Additional documents included each month. – Process monitoring: regular monitoring and analyzing data related to the manufacturing process, such as production rates, quality metrics, and environmental factors, to identify trends or potential issues and take action as needed. Additional documents included each month.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 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

Express Pharma

OCTOBER 31, 2024

Though you have never seen a patient you start feeling happy when the patient is improving. If the patient has any adverse event you also get as worried as them. People may not be dealing with patients, but somebody who is doing case processing of an adverse event, must not look at it only as a document to fill in data.

Drug Development 105

Drug Development Hospitals Process Improvement Documentation 105