PRECAUTIONS DURING PRODUCTION ACTIVITY
v Dispensing of all the raw materials should be
done in dispensing area, which should be maintained
v Clean, dust free and hygienic to prevent
contamination. Dispensed raw material should be labeled and
v Signed by store, production and QA person to
ensure correct quantity. Follow SOP of Dispensing of
v Raw Materials (As per SOP No.).
v Ensure that all the cleanable filters are
cleaned as per their schedule.
v All the dispensed raw materials should be
moved in double lined poly bags duly labeled and then to be
v Stored in the SS dispensing box and label shall be affixed (As per SOP No.).
v Manufacturing process or any operation in the
manufacturing process should not be started until the prescribed environmental
conditions are within limits. Follow SOP of Monitoring of Temperature and
Relative Humidity (As per SOP No.).
v Filtration, filling and sealing activity shall
be carried out under sterile conditions.
v Use Nose Mask, Hand Gloves and Safety Goggles
etc. protective apparels to prevent contamination from human body as well as to
protect from micronized dust particles of the material being handled during the
entire operation.
v Entire operation shall be carried out as per
the above stated precautions and in BMR. No deviation is permitted. If at all
violation of the standard procedure is to be made prior authorization is
necessary so that if the new procedure is beneficial, the standard procedure
can be modified according to change control procedure (As
per SOP No.). and handling of temporary change procedure (As per SOP No.)
v Make neat and clean records, sign the records
only after ensuring the operation has been carried out. Do not
obliterate the mistake, instead cross the wrong reading. Follow SOP of GDP (As
per SOP No).
PACKAGING
CONDITIONS AND PRECAUTIONS
v Entire operation shall be carried out as per
GMP and SOP of Packing of Batch (As per SOP).
v Make neat and clean records, sign the records
only after ensuring the operation has been carried out.
v Do not obliterate the mistake, instead cross
the wrong reading. Make the correct entry and then sign or write initial with the date and reason
for correction, if possible. Follow SOP of GDP (As per SOP No.).
v Utmost care to be exercised for dispensing of
printed packaging materials.
v Packaging process or any operation in the
packaging should not be started until the prescribed
v Environmental conditions are within limit.
Follow SOP of Monitoring of Temperature and Relative
v Humidity (As per SOP No).
v Entire operation shall be carried out as per
the above stated precautions and in BPR. No deviation is permitted. If at all
violation of the standard procedure is to be made prior authorization is
necessary so that if the new procedure is beneficial, the standard procedure
can be modified according to change control procedure (As per SOP No). And
handling of temporary change procedure (As per SOP No).
Scrap
generated of rejected labels during packaging operation shall be destroyed.
PACKAGING PROCEDURE AND IN-PROCESS CONTROLS
Packaging Procedure:
v
Send all
the optically good vials to the packing department.
v Ensure that all secondary / tertiary packaging
materials like Cartons, Labels, Box labels, Literatures of
v Previous product / batch are removed before
taking new batch.
v After receiving the printed label
from packaging material store.
v Start the packing of the batch as per SOP No.
v QA person shall withdraw the control samples (As
per SOP No) and stability samples (As per SOP No.) (whenever applicable)
randomly at the start, middle and at the end of packing of batch.
v At the end of the packaging, packing
supervisor shall give Intimation docket of finished product with
v Sample to QC through IPQA person for analysis.
v After release of batch from QC, the batch
shall be transferred from quarantine area to approved area
v In FG warehouse.
v QA person shall collect samples from FG (As
SOP No.) quarantine on intimation or as per planning of stability schedule.
v Affix label on bottom right corner of
corrugated box with a stamp mentioning the quantity.
v In-process Controls:
v In-process checks
shall be done as per SOP No.
v Check labeling quality every hour and In-process checks of shippers every
hour.
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