PROCEDURE FOR ANALYSIS

The following is the manner in which various departments send an intimation to Q.C. when any analysis is required.

a)         When a consignment of raw materials is received by Stores, intimation is sent to Quality Control Department on a Goods Received  (G.R.)  Note

b)         Whenever manufacture of any bulk drug or formulation is  complete, ‘Test Request’ (T.R.) Forms are sent by Production Departments to the Quality Control Department as an intimation for sampling.

c)         The Production Department for all intermediates and in-process samples sends technical Information T.I. sheets Samples are sent by the Production Department  alongwith the T.I. sheets.

1                    After receiving the G.R. notes/T.R. forms/T.I. sheets, make entries in the relevant Analytical Reference  Number register, assigning an A.R. Number to each batch.

2                    Collect samples of the material/product form the Production  Department/Stores, and keep these in the designated placed.   Affix Under Test labels on the containers.

Refer to the sampling checkliste for individual items  .

3                    Check the individual samples for their physical uniformity,  eg. color, nature,      appearance, etc.

Refer to the General Analytical methods.

4                    If they pass the preliminary examination, pool these together to form a composite  

            sample.

5.         Withdraw a quantity from the composite sample to keep as  ‘Reserve Sample’, equivalent to 2 analyses .

6.         Carry out the analysis on the 3rd portion of composite sample.

7.         Record all details of tests carried out ( like weights,  volumes, dimensions, normalities, absobencienes and other  readings ) on the reverse side of the Analytical Report/Q.C. copy of the T.I. sheet.

8.         Record the results/conclusions on the front of the same sheet or generated on a computer.  Attach all spectra and other,  printed data pertaining to the tests to the Analytical Test Report.

9.         Have all calculations checked by a second chemist.

10.       Indicate on the Analytical Test Report and GR note copy whether the same complies with its specifiction or not by stamping the words ‘Passed’ or ‘Rejected’ except in case of samples accompanying T.I. sheets where only results are to be reported.   Give reasons in case of rejections.

11.       Enter the status of the material in the relevant Analytical Reference Number Register (Passed, Rejected or Reported).

12.       Prepare the ‘Passed’ or ‘Rejected’ labels and get these affixed under your supervision, in such a manner that the yellow  portion of the ‘Under Test’ label is completely covered. Passed/ Rejected labels should be put on every container.

13.       Retain the Analytical Report and one copy of the G.R. Notes and send the remaining copies to the Stores.

        When a material has to be retested for any reason, ‘Quarantine’ labels are affixed by the Stores/Production over the’Passed labels and T.I. sheet is sent to the Q.C. by the concerned     department.

14.              Re-analyse the material as above and insure fresh ‘Passed’ ‘Rejected labels.