SOP for Operation of the Manufacturing Area

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 vapors. 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 labeled.

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, footwears gloves, etc.

Ensure that the chemist checks the packing materials used for batches.

Any rejected packing materials are kept in a separate crate and labeled.

Check that the labeling machine, turntable, and checking unit are in working condition.

To provide a procedure for 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 color 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.