Are you evaluating their capabilities prior to using them? An API facility recently received this 483 observation:  …..Contract laboratories are not evaluated to ensure GMP compliance. Specifically, your firm has repeatedly demonstrated that you have no assurance in the capability of your contract laboratories to perform testing that ensures compliance... Are you evaluating their capabilities prior to using them? An API facility recently received this 483 observation:  …..Contract laboratories are not evaluated to ensure GMP compliance. Specifically, your firm has repeatedly demonstrated that you have no assurance in the capability of your contract laboratories to perform testing that ensures compliance...

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Do you have a well defined program to ensure your employees know what they are looking for during a visual inspection? A company recently received this 483 observation:    …..Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions. Specifically,... Do you have a well defined program to ensure your employees know what they are looking for during a visual inspection? A company recently received this 483 observation:    …..Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions. Specifically,...

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By Executive Assistant

Have you established in-process hold times? A company recently received this 483 observation:  …..Deviations from production time limits are not documented. Specifically, excursions in hold time are not investigated, trended or otherwise evaluated for product impact.  There have been multiple hold time excursions for multiple drug products.  Your firm's Annual... Have you established in-process hold times? A company recently received this 483 observation:  …..Deviations from production time limits are not documented. Specifically, excursions in hold time are not investigated, trended or otherwise evaluated for product impact.  There have been multiple hold time excursions for multiple drug products.  Your firm's Annual...

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By Executive Assistant

Are you all using the "Administrator" password? A company recently received this 483 observation:  ….Computerized systems do not have sufficient controls to prevent unauthorized access or changes to data. Specifically, unique user identifications have not been established for computerized systems used in the QC Laboratory.  All personnel share the “Administrator”... Are you all using the "Administrator" password? A company recently received this 483 observation:  ….Computerized systems do not have sufficient controls to prevent unauthorized access or changes to data. Specifically, unique user identifications have not been established for computerized systems used in the QC Laboratory.  All personnel share the “Administrator”...

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By Executive Assistant

Did you requalify your equipment when the repairs were completed? A company recently received this 483 observation:  …..Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance. Specifically, the firm failed to adequately requalify (i.e. temperature distribution) stability chambers and stability room... Did you requalify your equipment when the repairs were completed? A company recently received this 483 observation:  …..Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance. Specifically, the firm failed to adequately requalify (i.e. temperature distribution) stability chambers and stability room...

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By Executive Assistant
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