Friday, December 24, 2010

Supporting Analytical Documents, Recording Result & Review Of Documents

Supporting Analytical Documents, Recording Result & Review Of Documents


4.1        The review shall ensure for the following at the time of reviewing the documents.

4.2        Filling of all the relevant details in record of analysis (Green sheet) and certificate of analysis.

4.3       Specification number is correct and current.

4.4        All the tests as per the specification are performed.

4.5        Correct use of standard and its potency alongwith AR No. of standard used.

4.6        Correct use of HPLC / GC columns.

4.7        All print-out, chromatograms duly signed and dated are attached with record of analysis.

4.8        Instrument number is mentioned in record of analysis for all the applicable tests.

4.9        Correct normality is used.

4.10      Correct KF factor is used.

4.11      Correct units of measurements are mentioned.

4.12      The review shall also ensure for following.

4.13      No overwriting and use of erasing fluid.

4.14      Cross outs are initialed and dated alongwith justification wherever applicable.

4.15      Rounding off of the results is done as per SOP “Rounding off of the analytical results”

4.16      Signature of analyst(s) and date wherever applicable.

4.17      Corrective of calculations.

4.18      Corrective of transfer of data from Record of Analysis to other relevant documents and Certificate of Analysis.

4.19      Justification for discarding the data (if any).

4.20      After going through the abovementioned requirements, the reviewer shall put his/ her signature and                        date on record of analysis.

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