Remove Compounding Remove Data Entry Remove Events
article thumbnail

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

Once the target is identified, researchers work to develop a compound that can interact with it. After a promising compound has been identified, it’s tested in preclinical models to evaluate its safety and efficacy. AI also helps in interactions with patients, as it can be used for automating patient recruitment and data collection.

article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

How to perform operational qualification – step by step

GMPSOP

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). Also, it can be integrated with other external interfaces. are functioning as expected.

article thumbnail

Typical GMP documentation in a quality control laboratory

GMPSOP

Data management policy : This policy governs activities for data entry, storage, and retrieval to ensure the integrity of laboratory results. Record keeping policy : this policy outlines procedures for documenting laboratory activities, including data, results, and observations.