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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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How to implement good documentation practice in a GMP regulated plant

GMPSOP

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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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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Data Integrity in the Pharmaceutical & Life Sciences Industry

Viseven

Data integrity isn’t a software, service, or product; it encompasses various solutions contributing to improved data maintenance and quality. Importance of Data Integrity in the Pharma Industry It takes just one wrong data entry, breach, or incident for patients and clients to lose your trust.

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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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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.