Monthly Archives: December 2015

Electronic Document Management System [EDMS]

Like procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken … Continue reading

Posted in Drug regulatory and guidelines, QMS, quality assurance | 1 Comment

Data Integrity (Part-III) (Some Major Observations)

Observation 1 Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed … Continue reading

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Data Integrity Part-II (Laboratory)

Most companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of … Continue reading

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Data Integrity -Part-I

The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and … Continue reading

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