STANDARD OPERATING PROCEDURE FOR OPERATION OF STRIP PACKING MACHINE

1. Objective: To describe the procedure for strip packing of Tablets/Capsules.

2. Scope: The procedure is applicable to strip packing machine.

3. Responsibility: 

Operator: To follow  as per the written down procedure

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

Head of the Department: Implementation of procedure.

4. DEFINITIONS:

Nil

5. REFERENCE:

S.O.P. Guidelines

6. PROCEDURE:

6.1 Clean the hopper and chute with nylon brush or scrubber using 0.5% Sodium Lauryl Sulphate (SLS) solution. Clean with portable   water and Rinse with purified water and wipe it using a clean dry lint free cloth. Clean the vibrator with clean damp cloth and then with clean dry cloth.

6.2 Maintain the temperature and humidity if necessary as specified in Batch Manufacturing Record.

6.3 Set the rollers, chute, back gear, cutting gear suitable for the product to get desired Pack size.  Check the release status of Bulk tablets/filled capsules from QC.

6.4 Get line clearances from QA regarding cleanliness of area & machine.

6.5 Start the mains of the machine and set the temperature of the roller by adjusting thermostat as follows:

a) For Glassine poly foil : 1350C to 1450C

b) For Aluminium foil : 1450C to 1550C

6.6 Load the Aluminium/Glassine Poly foil and corresponding plain/printed foil rolls depending upon the product specification.

6.7 Obtain corresponding rubber stereos from Department, and set the printing unit. Mix ink and thinner in right proportion so as to give sharp printing on the foil. Get some printed foil  (representing not less than one complete rotation of the printing cylinder ), check it for overprinted batch details like B.No., Mfg. Dt., Mfg. Lic. No. , Code No., Expiry date, price, Physician Sample (PS) (if required) etc. and sign. Get it counter checked and signed by QC chemist. Attach the approved specimen to batch manufacturing record.

6.8 Load the hopper with tablets/capsules and label the hopper, with product name, Batch No.,  B.Size,  and date.

6.9 Adjust the vibrator so that the tablets/capsules shall pass through chute and get trapped in the cavity between the foils.

6.10 Carry out the leak test on the initial strips as per the standard operating procedure for Leak testing of strips whenever applicable (PDN/069/R1).    Number of strips taken should cover the total cavities on the roller. In case of failure in leak   test, reset the machine and repeat the leak test.

6.11 Once the machine gets set, perform leak test every two hours and keep a record of the same in Packing record.

6.12 Collect the stripped tablets/capsules into the drum duly labeled with all relevant details.

6.13 Check the strips intermittently for correctness of overprinted details tablet/capsules fall, cut pockets, printed details etc.

7  RECORD:

Batch Manufacturing Record:

8. Revision History

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.

Allotment of Lot numbers to volumetric solutions, buffer solutions, test solutions, HPLC mobile phases and Primary standards

1.0	OBJECTIVE :
	To  provide  the  procedure  for  allotting  lot  numbers  to  volumetric solutions,
	buffer  solutions, test  solutions, HPLC mobile phases and Primary standards.
	This system helps in identifying the solutions used in Analytical Development
	laboratories.
2.0	RESPONSIBILITY :
2.1	Analytical Development officer whoever prepares these solutions to allot the lot number.
2.2	AR&D Manager to ensure compliance.
3.0	PROCEDURE :
3.1	Volumetric Solutions
3.1.1	Prepare  volumetric  solutions as mentioned in the General Test Procedure of
	respective  volumetric solution  and  allot  a   separate   lot  number   for   each
	volumetric solution.
3.1.2	The   lot   number   shall   indicate   code   of   respective   volumetric   solution
	(annexure - 1), normality/molarity value, N/M (normality/molarity), serial number
	in sequential order and restandardization number in sequential order.
3.1.3	For example,  the lot number for 0.5N hydrochloric acid prepared first time
	and standardized first time shall be ADHA(0.5N)01-00.
3.1.4	The same solution if restandardized, the lot number shall be given as
	ADHA(0.5N)01-01.
3.1.5	The same solution if restandardized for second time the lot number shall be
	given as ADHA(0.5N)01-02.
3.1.6	Refer Annexure -1 for code of  various volumetric solutions.
3.1.7	The lot number for 0.5M H2SO4 prepared and standardized for first time
	shall be ADSA(0.5M)01-00

3.1.8	Serial number shall start from 01 for each individual volumetric solution every
	new year (1st January)
3.1.9	Each volumetric solution shall have expiration date. Expiration periods for
	various volumetric solutions mentioned in annexure -1.
3.1.10	Each volumetric solution shall be labelled (annexure -5) after preparation and
	standardization.
3.1.11	Each  volumetric  solution  shall  be  restandardized on the day of use.
3.1.12	Enter the details of preparation and standardization of volumetric solution
	in "Record of Analysis". (Annexure - 2)
3.2	pH Buffer Solutions :
3.2.1	Prepare  pH  Buffer  Solutions  as  mentioned  in  the General Test procedure
	"pH" and allot a separate lot number for each individual pH buffer solution.
3.2.2	The lot number indicate shortform of the buffer solution (BS), pH value and
	serial number in sequential order.
3.2.3	For  example, lot  number  for  pH  4.0  buffer  prepared  first  time  shall  be
	ADBS(4.0)01.
3.2.4	The  same  buffer  if  prepared  second  time the lot number shall be given as
	ADBS(4.0)02.
3.2.5	For  example, lot  number  for  pH  7.0 buffer  prepared  first  time  shall  be
	ADBS(7.0)01.
3.2.6	Similarly, lot number for pH 9.2 buffer prepared first time shall be ADBS(9.2)01.
3.2.7	The serial number shall start from 01 for each individual buffer solution every
	new year (1st January).
3.2.8	Enter the details of preparation of buffer solution in "Record of Analysis"
	(Annexure - 3).

3.2.9	Each buffer solution shall be labelled (Annexure -4) after preparation.
3.3.10	Buffer solutions shall be used within 8 days from the day of preparation.
3.3	Test Solutions
3.3.1	Test  solutions  include indicators, colorimetric solutions, test solutions and
	any other solutions except volumetric solutions, Buffer solutions and HPLC
	mobile  phase. Prepare  test  solutions  as  mentioned in Monographs and
	allot reference number for each individual test solutions.
3.3.2	Reference number is A.R.Number in case of R&D samples analysis, Experiment number
	in case of Analytical Method development experiments,Validation protocol number
	in case of Analytical method validation.
3.3.3	Enter  the  details  of  preparation  of  test  solutions  in worksheets in case of R&D
	samples analysis, in registers in case of method development and method validation.
	The label shall contain the details like Name, Date of preparation, Use before date,
	Prepared by and reference number.
3.3.4	Each test solution shall be labelled (Annexure - 4) after preparation.
3.3.5	Test solution shall be used within 30 days from the day of preparation, unless
	otherwise specified in the individual monograph.
3.4	HPLC Mobile Phases :
3.4.1	Prepare HPLC mobile phase as mentioned in monographs/STPs and allot a
	reference number for each individual mobile phase.
3.4.2	Reference number of mobile phase shall be AR No. incase of R&D support
	group, Experimental No. incase of method development, validation protocol No.
	incase of method validation
3.4.3	Each HPLC mobile phase shall be labelled (Annexure - 4) after preparation.
3.4.4	Prepare HPLC mobile phase fresh before use.

3.4.5	Record the mobile phase preparations in respective worksheets, in case of
	R&D support group, in the Validation Registers in case of Method Validation group, in
	the Experimental Register in case of Method development.
3.5	Primary Standards :
3.5.1	Primary standards used for standardizing volumetric solutions, preparation of
	pH buffers, preparation of limit test standard solutions, Colorimetric solutions
	etc.,  shall be dried in a shallow weighing bottle at specified temperature and
	for specified time as mentioned in the respective GTP/STP.
3.5.2	The primary standards after drying, shall be cooled to room temperature in
	a desiccator.
3.5.3	Dried primary standards shall be opened for a minimum time while using.
	After use they shall be replaced in the desiccator.
3.5.4	Each primary standard dried shall be given a lot number.
3.5.4.1	Primary standard lot number shall consists of seven characters.
3.5.4.2	The first two characters are ADPS indicating primary standard.
3.5.4.3	The  next three characters  indicate  the  serial  number  in  sequential  order
	starting from 001 every new year (1st January).
	E.g.. : The first primary standard dried  in year '97 shall be given Lot Number
	as ADPS001.
3.5.5	Enter the details of drying in "Primary standard drying register" (annexure -6)
3.5.6	After drying, the primary standard shall be used within 8 days from the date of
	drying.
3.5.7	At the time of drying the weighing bottle shall be labeled with the name of
	primary standard by marker pen. After drying is over it shall be labeled with
	details as per annexure-7.

4.0	DOCUMENTATION :
4.1	Codes of various volumetric solutions - Annexure 1.
4.2	Specimen format of "Record of Analysis" volumetric solutions - Annexure  2.
4.3	Specimen format of "Record of Analysis - pH Buffer solutions"  - Annexure 3.
4.4	Specimen format of "Lables of pH buffer solutions, Test solutions, HPLC mobile phases"
	- Annexure 4.
4.5	Specimen format of label for "Volumetric solutions" - Annexure 5.
4.6	Specimen format of "Primary Standard Drying register " - Annexure 6.
4.7	Specimen format of "Primary Standard Label " - Annexure 7.

Users of this SOP are requested to prepare suitable annexures on their own.