sop for monitoring of reprocessing of products
To lay down the procedure for monitoring of Reprocessing of product.
Quality Control Officer / Quality Assurance Officer.
Quality Assurance Manager
4.1 Procedure of reprocessing is applicable to products for domestic market.
No reprocessing shall be carried for export market.
4.2 Check and ensure that recovery to be added in the fresh recovery
batch is not more than 3 months old.
4.3 Ensure that the batch wise recovery to be added to the fresh recovery
batch is the same as recovered and reconciled primarily batch wise.
4.4 Ensure that manufacturing date of the batch is given of the month in which it is reprocessed.
4.5 The expiry of the batch shall be given as shortest as of the batch holding shortest expiry.
4.6 Ensure that the total calculated quantity of recovered blend is correct
4.7 Carry out line clearance at startup of each stage of processing as per SOP on line clearance.
4.8 Ensure that the correct integrated sieve is being used for sifting of the granule as specified in BMR.
4.9 Collect the samples of the blended granules and submit it to quality control for analysis along with BMR.
4.10 Check the result of analysis and follow the recommendation of quality control for further processing of the batch.
4.11 If the result of analysis is approved by quality control then affix ‘Approved “ label
to product bin for clearance. if any addition of active ingredient is recommended then
allow to production for addition of the same and collect the sample after addition of
the required material and blending.
4.12 Again submit the sample to quality control for analysis and follow pt. n. 4.10 & 4.11.
4.13 If the reprocessing in carried for the product first time , evaluate the stability of
the product at accelerated stability study condition of 40 °C and 75 % RH.
4.14 The product shall remain in hold till one month accelerated stability data is
found well within the acceptance criteria of accelerated stability studies.
4.15 The new reprocessed product shall be released only after completion of one
month of accelerated stability study , but the study shall be continued for
duration as per stability protocol.
4.16 Ensure that leftover of the reprocessed batch is destroyed and neither
stored as recoverable nor added to any other batch
4.17 Monitor and control the complete operation of manufacturing.
RH = Relative Humidity
6.0 REFERENCES/ ANNEXURES