To provide a procedure for the operation of the manufacturing area, the procedure for a sampling of raw material, a procedure for the operation of the filling area, and the Operation of the packaging area. Procedure for overprinting of packaging materials.
SCOPE
Covers the operation of the manufacturing area in the Liquid department for product changeover.
RESPONSIBILITY
Production Chemist,
Production In-charge
ACCOUNTABILITY
Production Manager
PROCEDURE
Before the commencement of a batch, check for the cleanliness of the area. Check for the status label on the equipment.
Ensure that the correct material is brought into the manufacturing area with a correct passing label. Check the primary changes & secondary changes of workers while entering the manufacturing area.
Check for the cleanliness of the workers like a clean apron, footwear gloves, etc. Ensure that the Purified water is checked by the Q. C. department.
Check the air changes that occurred in the manufacturing area, allowable to start the manufacturing. Carry out the manufacturing process as given in the B.M.R.
To provide the procedure for the sampling raw material.
SCOPE
Covers the sampling of raw materials in the factory.
RESPONSIBILITY
Store In-charge, Q. C. Chemist.
ACCOUNTABILITY
Store Manager.
PROCEDURE
On receipt of goods, the raw material store will inspect them physically.
He will tally with a delivery memo.
A raw material supervisor will segregate all the containers lot or batch-wise.
The raw material supervisor will affix sticker labels on each and every
container.
The raw material supervisor will prepare GOODS RECEIPT NOTE batch or lot wise.
GOODS RECEIPT NOTE will be handed over to Quality Assurance Chemist
He will enter the Goods receipt note in the ENTRY BOOK with the necessary
details.
Entry will be done on FIRST COME, FIRST BASIS.
Check container details against its GOODS RECEIPT NOTE.
If discrepancies, inform to raw material store in charge and
Quality Assurance In charge. After consultation, make necessary corrections in
Goods Receipt Notes and get it authenticated. Inform Q.C Dept. to arrange for
sampling.
Affix the ON-TEST sticker on each and every container.
Draw the sample as per sampling S. O. P.
Draw Sufficient and Representative samples using suitable clean sampling
devices such as Spatula, S. S. Sampler, Scoop, etc.
Make a COMPOSITE sample taking an equal quantity of the sample.
Make two sets of composite samples one for CONTROL SAMPLE and another
for testing.
Forward testing sample to Q.C. Laboratory and preserve CONTROL SAMPLE.
LABEL the sample appropriately i.e.
Name of the material
Batch/lot number
Manufacturing and expiry date
Goods receipt number
Quantity received & date
Manufactured by.
Get the container tied and sealed after sampling.
Light-sensitive and hygroscopic material is to be protected during
sampling and special care is to be taken. Such samples are to be immediately
sealed and kept in a light-resistant sample container.
Mark SAMPLED & initial it and put a date on the container from which the sample is drawn.
If the drug meets the specification affix the APPROVED and if not OUT OF SPECIFICATION
/ REJECTED label on containers.
Advise the Raw Material Store Supervisor to transfer the Drug in the respective area of APPROVED and OUT OF SPECIFICATION / REJECTED.
Get the sampling device cleaned thoroughly using a suitable solvent and then dematerialize
water. Blow it to dry and use it for the next sampling.
SAMPLING OF LIQUID.
Use clean (sterilized or wiped with isopropyl alcohol for
microbiological analysis) corning glass hollow tubes or corning bottles or another
suitable device.
Collect samples from the Top, Middle, and Bottom layers of the container.
Observe for any contamination of the liquid. It is noted down.
If the liquid is in a TANKER or BULK LOAD, collect representative samples from each compartment/
container.
Allow it to unload if it is approved and mark APPROVED on those drums
that are filled from approved tanker material.
Avoid inhalation of vapours. Use hand gloves, face hood, etc. safety
measures during sampling.
Other points are the same as previous.
Preserve the Control Sample till one year after the expiry of the raw
material.
Mark SAMPLED & initial it and put a date on the container from which the sample is drawn.\
To provide a procedure for the Operation of the filling area
SCOPE
Covers the operation of the filling area in the Liquid department
for product changeover.
RESPONSIBILITY
Production chemist, Production In-charge.
ACCOUNTABILITY
Production Manager
PROCEDURE
Before the commencement of a batch, check for the
cleanliness of the area.
Check for the temperature of the area and record it in the
Batch Manufacturing Record.
Check for the status label on the equipment.
Check for the cleanliness of the workers like a clean apron,
footwear gloves, etc.
Ensure that the Liquid to be filled is passed by the Q.C.
department.
Carry out the filling process as per the S.O.P
Any rejected bottles are kept in a separate crate and labelled.
To provide a procedure for the operation of the parking area.
SCOPE
Covers the operation of the parking area in the Liquid department
for product changeover.
RESPONSIBILITY
Production chemist, Production In-charge.
ACCOUNTABILITY
Production Manager
PROCEDURE
Before the commencement of a batch, check for the
cleanliness of the area.
Check for the status label on the equipment.
Check for the cleanliness of the workers like a clean apron,
footwear gloves, etc.
Ensure that the chemist checks the packing materials used
for batches.
Any rejected packing materials are kept in a separate crate and
labelled.
Check that the labelling machine, turntable, and checking unit
are in working condition.
To provide a procedure for the overprinting of packaging materials.
SCOPE
Covers the procedure for overprinting of packaging material.
RESPONSIBILITY
Overprinting operator, Packing chemist, I. P. Q. A. Chemist
ACCOUNTABILITY
Store Manager.
PROCEDURE
The text i.e. Batch Number, Manufacturing Date, and Expiry Date are supplied by the packing chemist to the overprinting section. A specimen of the text overprinted is verified by the production chemist rechecked by the packing chemist and finally by the quality control department.
The signed specimen of the overprinted text is preserved
in the overprinting section. The same text is recorded, signed, and kept in B.M.R.
After the completion of the overprinting, the full quantity of packaging
supplies is stored to remove blank, misprinted, and distorted ones. The sorted quantity is kept in the packing area, segregated to avoid any mix-up of B. No.
or of the same colour packing supplies. Overprinted text is approved by quality
control.
The rejected quantity is reconciled and disposed of under the supervision of the production supervisor. When complete overprinting is done, the area and equipment are cleaned and stereos are destroyed in the presence of the line supervisor.