STANDARD OPERATING PROCEDURE FOR CLEANING OF PACKING EQUIPMENTS

1. OBJECTIVE          

    To describe the procedure for cleaning of packaging equipments.

2. SCOPE      

    The procedure is applicable to cleaning of all the equipments used in packing.

3. RESPONSIBILITY

Operator: To follow as per the written down procedure.

Packing Supervisor: To monitor and execute the written down procedure.

Head of Department: Implementation of the procedure

4. DEFINITIONS:

Nil

5. REFERENCES.

    S.O.P. Guidelines

6. PROCEDURE

6.1.      Before starting the packing of product, powder/dust shall be removed from the equipments

            by using a vacuum cleaner.

6.2.      By means of vacuum cleaner, poly-bag sealers shall be cleaned followed by wiping with a

            clean dry lint-free cloth.

6.3.       Cleaning of hand counters, plastic tubs, aluminum trays shall be done by using 0.5 %

             Sodium Lauryl Sulphate solution and then washed with potable water followed by purified

             water and then finally wipe with clean dry lint free cloth.

6.4.       Cleaning of weighing balances  :

         6.4.1.     Check and ensure that the mains are put off before starting cleaning.

         6.4.2.      By means of vacuum cleaner spilled powder/dust shall be removed.

         6.4.3.     Thorough cleaning of the balances shall be done with a dry lint free cloth. 

 7. RECORD                         : 

    Batch Manufacturing Record

 8.     Revision History

STANDARD OPERATING PROCEDURE FOR RECONCILIATION OF THE PACKING MATERIALS

1. OBJECTIVE

To describe the procedure for the accountability of the packing materials used for packing of a product.

2. SCOPE

The  procedure  is  applicable  for  reconciliation  of  the  packing  materials  after completion  of packing.

3. RESPONSIBILITY

Operator: To follow as per the written down procedure.

Packing Supervisor: To monitor and execute the written down procedure.

Head of Department: Implementation of the procedure

4. DEFINITIONS:

Nil

5. REFERENCES.

S.O.P. Guidelines

6. PROCEDURE

6.1. To know the quantities of all packing materials used after completion of a batch, below mentioned details are recorded in BMR.

6.1.1. Actual quantity issued.

6.1.2. Actual quantity used.

6.1.3. Quantity wasted or rejected on line.

6.1.4. Quantity  returned  to  Stores

6.1.5. Quantity of control  samples.

6.1.6. Quantity of reference sample.

6.1.7. Total of the above from 6.1.2  to  6.1.6.  which shall be equal to the quantity as per 6.1.1.  

7. RECORD                         : 

    Batch Manufacturing Record

8. Revision History

STANDARD OPERATING PROCEDURE FOR PACKING OF BULK PRODUCTS

1. OBJECTIVE          

To describe the procedure about the packing of bulk tablets.

2. SCOPE      

The procedure is applicable for packing of bulk tablets.

3. RESPONSIBILITY

Operator: To follow as per the written down procedure.

Packing Supervisor: To monitor and execute the written down procedure.

Head of Department: Implementation of the procedure

4. DEFINITIONS:

Nil

5. REFERENCES.

S.O.P. Guidelines

6. PROCEDURE

6.1. Before starting the packing, the packing area shall be checked for proper cleaning.

6.2. Obtain line clearance from QA for starting of packing.

6.3. Only one product shall be taken for packing at a time.

6.4. Check that the labels on the bulk containers for the Product Name, Batch Number etc., is

        matching with the printed packing materials.

6.5. Ensure the  approval of bulk tablets from Quality Control.

6.6. Check that all packing materials issued are approved by Quality Control.

6.7. The  packing area shall have a status label containing Product Name, Batch Number,

       Manufacturing Date and Batch Size.

6.8. Packing supervisor shall be instructed to check whether the personnel involved in the

       packing area are properly wearing nose masks, hand gloves, Head caps etc.,

6.9. Before packing the tablets are to be  dedusted and inspected.  Counted tablets are

       collected in poly bags and sealed immediately.

6.10. Sealed poly bags are packed in jars along with all the packaging materials like packing

         insert,  Silicagel, Tagger seal  etc.,  or follow the instructions as per the Batch

         Manufacturing Record.

6.11. Close the jars with the lid

6.12. Jars are labeled with the approved labels.

6.13. Labeled jars are put in the corrugated shipper, seal it with the BOPP tape and label the

         shipper accordingly.

6.14. Quality Assurance chemist shall check randomly quantity and quality of the tablets packed

         in a jar.

6.15. All  packaging materials issued are as per the packing materials indent and reconciled and

        details are recorded in the BMR.

7. RECORD                         : 

    Batch Manufacturing Record

8. Revision History

STANDARD OPERATING PROCEDURE FOR CLEANING OF PACKAGING AREA

1. OBJECTIVE          

To describe the procedure for cleaning of packing areas.

2. SCOPE      

This procedure is applicable for the cleaning of Bulk packing area / Strip packing area / blister

packing area / Strip sealing area/ blister sealing area.

3. RESPONSIBILITY

Operator: To follow as per the written down procedure.

Packing Supervisor: To monitor and execute the written down procedure.

Head of Department: Implementation of the procedure

4. DEFINITIONS:

Nil

5. REFERENCES.

S.O.P. Guidelines 

6. PROCEDURE

6.1.     Cleaning of bulk packaging area:

6.1.1.   By means of dry cloth and vacuum cleaner dust shall be removed from all the doors,

windows, door joints, wall and wall corners and glass beadings.

6.1.2.   Thorough cleaning of floor is done by using cotton/synthetic wet mop with one percent liquid

soap solution followed by 5% disinfectant solution.  Floor cleaning shall be done four times a

day/product change over using this procedure. Temperature and relative humidity should be recorded three times a day, for all the areas, wherever required.

6.1.3.   Spillage of the materials in packaging area shall be removed from time to time.

6.1.4.   As soon as the packing of the product is completed, packing area shall be cleaned before

starting packing of the other product, so that cross contamination of the product is prevented.

6.1.5.   Enter the temperature, relative humidity and cleaning details in the log sheet: QAD/nnn:znn/rz

6.2.     Cleaning of Strip sealing area:

6.2.1.   By means of dry cloth and vacuum cleaner dust shall be removed from all the doors,

windows, door joints, wall and wall corners and glass beadings.

6.2.2.   Thorough cleaning of floor is done by using cotton/synthetic wet mop with one percent liquid

soap solution followed by 5% disinfectant solution.  Floor cleaning shall be done four times a

day/product change over using this procedure. Temperature and relative humidity should be recorded three times a day, for all the areas, wherever required.

6.2.3.   Spillage of the materials in strip sealing area shall be removed from time to time.

6.2.4.   As soon as the strip sealing of the product is completed, strip sealing area shall be cleaned

before starting strip sealing of the other product, so that cross contamination of the product is

prevented.

6.2.5.   Enter the temperature, relative humidity and cleaning details in the log sheet: QAD/nnn:znn/rz

6.3.    Cleaning of Blistering area:

6.3.1.   By means of dry cloth and vacuum cleaner dust shall be removed from all the doors, windows

door joints, wall and wall corners and glass beadings.

6.3.2.   Thorough cleaning of floor is done by using cotton/synthetic wet mop with one percent liquid

soap solution followed by 5% disinfectant solution.  Floor cleaning shall be done four times a

day/product change over using this procedure. Temperature and relative humidity should be recorded three times a day, for all the areas, wherever required.

6.3.3.   Spillage of the materials in blistering area shall be removed from time to time.

6.3.4.   As soon as the blistering of the product is completed, Blistering area shall be cleaned before

starting blistering of the other product, so that cross contamination of the product is

prevented.

6.3.5.   Enter the temperature, relative humidity and cleaning details in the log sheet: QAD/nnn:znn/rz

7. RECORD: 

Temperature, relative humidity and cleaning log sheets.

8.Revision History 

STANDARD OPERATING PROCEDURE FOR PACKING OF BLISTERS/STRIPS

1. PROCEDURE:

To describe the procedure for packing of Blisters/strips.

2. SCOPE:

The procedure is applicable for secondary packing of blister/strips.

3. RESPONSIBILITY:

Operator: To follow as per the written down procedure.

Packing Supervisor: To monitor and execute the written down procedure.

Head of Department: Implementation of the procedure

4. DEFINITIONS:

Nil

5. REFERENCES:

S.O.P. Guidelines 

6. PROCEDURE:

6.1 Before starting the packing, the packing area shall be checked for proper cleaning.

6.2 Ensure previous batch materials are removed from the area.

6.3 Obtain line clearance from QA before starting of the packing.

6.4 Only one product shall be taken for the packing at a time.

6.5 Obtain approval for blisters/strips from the quality control.

6.6 Check that all packing material issued, are approved by the quality control.

6.7 Overprinted packing materials are subjected to 100% inspection for the correction of Batch No, Mfg Date, Exp. Date details.

6.8 Check that the Blister/Strips for the Product Name, Batch Number, Manufacturing Date and Expiry Date are matching with the printed material.

6.9 Blisters/Strips are to be checked manually for the defects like  missed tablet / capsule, broken tablet / capsule, spotted tablet / capsule or smudged printing etc.,

6.10 Good Blisters/Strips are packed in cartons along with inserts or any other materials wherever it is applicable and counter checked by weighing simultaneously.

6.11Pack the cartons in a corrugated shipper, seal it with a BOPP tape and label the shipper accordingly.

6.12 Quality assurance chemist shall check randomly quantity and quality of the tablets packed in a carton.

7. RECORD:     Batch Manufacturing Record.

8. REVISION HISTORY:

STANDARD OPERATING PROCEDURE FOR DEDUSTING AND INSPECTION OF TABLETS

1. OBJECTIVE:

To describe the procedure for dedusting and inspection of tablets.

2. SCOPE:

The procedure is applicable to dedusting and inspection of tablets.

3. RESPONSIBILITY:

Operator: To follow as per the written down procedure.

Packing Supervisor: To monitor and execute the written down procedure.

Head of Department:  Implementation of the procedure

4. DEFINITIONS: Nil

5. REFERENCES:

S.O.P. Guidelines

6. PROCEDURE:

6.1 Before starting the dedusting/inspection of the tablets, dedusting area shall be cleaned properly by using cotton/synthetic wet mop with 1% liquid soap solution followed by 5% of disinfectant solution.

6.2 Cleaning of the plastic tubs shall be done by using 0.5% Sodium Lauryl Sulphate solution and then washed with the potable water followed by purified water and then finally wipe with clean dry lint-free cloth.

6.3 Obtain line clearance from QA for dedusting/inspection of the product.

6.4 Switch on the dedusting machine and put tablets gently in the perforated tubs and rattle the tablets over the dedusting machine, so that all the loose powder shall be sucked by the deduster.

6.5 Put the tablets on the inspection table and the tablets are to be manually checked for the defects like broken tablets, black spotted tablets etc.,

6.6 After following the above procedure, the tablets shall be ready for packing as per the packing code.

7. RECORD:

Batch Manufacturing Record.