sop for monitoring of reprocessing of products
1.0 OBJECTIVE
To lay down the procedure for monitoring of Reprocessing of product.
2.0 RESPONSIBILITY
Quality Control Officer / Quality Assurance Officer.
3.0 ACCOUNTABILITY
Quality Assurance Manager
4.0 PROCEDURE
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.
5.0 ABBREVIATIONS:
RH = Relative Humidity
6.0 REFERENCES/ ANNEXURES
NIL
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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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