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Typical GMP documentation in a quality control laboratory

GMPSOP

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

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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. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

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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.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

This can be achieved by implementing electronic systems with built-in controls to maintain data integrity, audit trails and access controls. Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital.

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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. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results. are functioning as expected.