sop for monitoring of reprocessing of products


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


Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel


sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

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