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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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VIATRIS (Mylan & Up-John Pfizer) -Openings for Regulatory Affairs Department -Apply Now

Pharma Pathway

(Merger between Mylan Laboratories & Up-John Pfizer) URGENT Opening @ VIATRIS for Regulatory Affairs- Injectables | Exp: 2-7 Years | Bangalore | Send Resumes to HR Department: Regulatory Affairs -Injectables Qualification : Masters in Pharmacy is mandatory Experience : 2 – 7 years Designation : Executive/ Assistant Manager Key responsibilities: (..)

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Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.

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Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.

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Overview of GLP requirements on everyday laboratory operations

GMPSOP

Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month. All sampling procedures and plans must be documented. All written and updated by GMP experts.

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Considerations for safety data migration methods

European Pharmaceutical Review

Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon. Once all cases have been entered and reviewed and any discrepancies resolved, the data transfer is considered complete and a data migration summary report should be issued.

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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.