Month: August 2020

Ciprofloxacin Hydrochloride 500 mg Tablets

August 27, 2020December 20, 2023 ABHA

Ciprofloxacin Hydrochloride 500 mg Tablets

PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

Master Copy: Manager Quality Assurance

Copy No. 1: Production Pharmacist

Copy No. 2: Manager Quality Control

Copy No. 3: Tablet Section

PRODUCT NAME: Ciprofloxacin Hydrochloride Tablet	BATCH SIZE: 2.0 LAC
PRODUCT REFERENCE CODE:	UNIT SIZE: 20 x 10
GENERIC NAME: CIPROFLOXACIN HCl TABLET I.P.	PACK SIZE: 60 x 20 x 10
DOSAGE FORM: TABLET	STRENGTH: N.A.
DEPARTMENT: TABLET DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each film coated Tablet contains:

Ciprofloxacin Hydrochloride I.P.

Equivalent to Ciprofloxacin 500 mg

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Steam Jacketed Starch Paste Preparation Tank
2	Sifter Machine – I
3	Roto Cube Blender –I
4	Rapid Mixer Granulator
5	Multi Mill
6	Fluidized Bed Drier
7	Oscillating Granulator
8	Sifter Machine – II
9	Roto Cube Blender – II
10	Tablet Compression Machine 27 Stations
11	Dedusting Machine
12	Tablet Inspection Machine
13	Rapid Coat Tablet Coating Machine
14.	Single Track Blister Machine

RAW M,ATERIAL:-

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	AEROSIL	B.P.	0.200 KG		0.200 KG
2.	CIPROFLOXACIN HYDROCHLORIDE	I.P.	50.000 KG	16%	58.000 KG
3.	DI CALCIUM PHOSPHATE	I.P.	1.500 KG		1.500 KG
4.	ISO PROPYL ALCOHOL	I.P.	13.750 KG		13.750 KG
5.	INSTACOAT WHITE	I.P.	1.750 KG		1.750 KG
6.	MICRO CELLULOSE CRYSTALLINE PHOSPHATE	I.P.	2.000 KG		2.000 KG
7.	MAGNESIUM STEARATE	I.P.	1.000 KG		1.000 KG
8.	METHYLENE CHLORIDE	I.P.	25.000 KG		25.000 KG
9.	STARCH	I.P.	5.5000 KG		5.500 KG
10.	STARCH	I.P.	2.000 KG		2.000 KG
11.	STARCH	I.P.	2.000 KG		2.000 KG
12.	TALCUM	I.P.	1.000 KG		1.000 KG

PACKING MATERIALS :

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1	84 MM CLEAR PVC	30.000		30.000 KG
2	ADHESIVE TAPE ROLL BROWN	1.000		1.000 KG
3	ALUMINIUM FOIL (CIPROMAC – 500)	6.000		6.000 KG
4	CELLO TAPE	2.000		2.000 KG
5	CORRUGATED BOX T – 10	16.000		16.000 NOS
6	UNIT CARTON (20 X 10) (CIPROMAC – 500)	1000.00	2.000	1002.00 KG

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.

Average weight of each Tablet is 730 milligrams.

Weight Variation Limit for average weight of 20 tablets is +0 %.

Friability limit for 20 Tablets is not more than 1.0 %.

Hardness of the Tablets varies between 4 – 6 kg/cm².

Disintegration time for each Tablet is not more than 30 minutes.

Dissolution limits for Ciprofloxacin HCl is not less than 80%.

Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 25˚C.

Perform the coating of the tablets at temperature not more than 25˚ C and humidity not more than 40%.

Yield:

Theoretical Yield is 2.0 Lac Tablets.

Expected Practical Yield is 2.0 Lac + 2% Tablets.

Packing Details:

Use 92 mm transparent PVC and Aluminium foil for blister packing.

Blister Pack the inspected and coated tablets by using Single Track Blister Packing Machine as per its SOP.

Put 20 strips each containing 10 tablets in each carton.

Seal each carton from both ends with cello tape.

Pack 60 cartons in a specified corrugated box to give a pack size of 60 x 20 x 10 tablets.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Preparation of Starch Paste:

Prepare the starch paste in the manner given below using Steam Jacketed Starch Paste Preparation Tank by operating it as per its SOP.

Add 2.0 kg of Starch in 4 Ltrs purified water and stir continuously to make smooth slurry.

Heat 36 Ltrs of purified water.

Add Starch slurry to the boiling water and stir continuously until smooth paste is formed.

Sifting: Fit Stainless Steel Sieve # 20 on the Sifter-I as per its SOP. Sift all the ingredients through it and collect separately in Stainless Steel Containers.

Blending: Blend the following ingredients using Roto Cube Blender by operating it as per its SOP for 15 minutes and collect in Stainless Steel Container.

0 kg of Ciprofloxacin Hydrochloride.

5 kg of Starch.

5 kg of Di Calcium Phosphate.

0 kg of M.C.C.P.

Wet Granulation: Mix the above blended ingredients with the Starch paste using Rapid Mixer Granulator by operating it as per its SOP. Add starch paste in such a manner by following the procedure given below so as to achieve proper wetting.

Divide the blended powder in four equal parts.

Divide the prepared starch paste in four equal parts

Mix the one part of blended powder and starch paste together in Rapid Mixer Granulator.

Similarly mix the rest of the parts in same manner.

Wet Screening: Pass the wet dough through a Multi Mill by operating it as per its to convert the moist mass into coarse, granular aggregates.

Drying: Dry the granules in Fluidized Bed Drier by operating it as per its SOP at temperature 60⁰ – 70⁰C for 30 minutes. Cool the granules to room temperature.

Sifting: Fit Stainless Steel Sieve # 20 on the Sifter-II as per its SOP. Sift all dried granules through it and collect in Stainless Steel Container. Break the oversized granules left over the mesh in Oscillating Granulator by operating it as per its SOP and resift them.

Check the total weight of dried granules. Determine the loss on drying and percentage yield of dried.

Lubrication: Lubricate the sifted granules along the following ingredients through Roto Cube Blender by operating it as per its SOP for 15 minutes and collect in Stainless Steel Container.

200 kg of Aerosil

0 kg of Magnesium Stearate

0 kg of Starch.

0 kg of Talcum.

Send the granules for bulk testing to Quality Control Department for assay of Active Ingredients.

Compression: Shift all the granules for compression to Tablet Compression Machine 37 Stations by operating it as per its SOP and collect the compressed tablets in Stainless Steel Container.

Tablet Inspection: Transfer all tablets to tablet inspection machine and sort out the defected tablets by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

Coating of the tablet: Dissolve 1.750kg of Instacoat white in 13.750kg of Isopropyl Alcohol. Then add 25kg of Methylene chloride to this solution. Colloid all the material in colloidal mill as per its SOP. Now start coating of the tablets by using Rapid Cota Tablet Coating Machine by operating it as per its SOP and collect the coated tablets in Stainless Steel Container.

Tablet Inspection: Transfer all coated tablets to tablet inspection machine and sort out the defected tablets by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

Blister Packing: Shift the inspected tablets to blister section and blister pack them using Single Track Blister Packing Machine by operating it as per its SOP.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Humidity and temperature should be maintained during the compression of thermolabile products.

Sample of dried granules should be sent to Quality Control Department for the determination of Moisture content.

The total weight of blended powder should be checked in the presence of Manufacturing Chemist and record the same in Batch Manufacturing Record.

Bulk sample should be sent for analysis to Quality Control Department before starting compression of tablets.

Weight Variation: Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

Out-of-limit tablets should be checked by Weight Variation Method as given below:

Take the average weight of 20 tablets on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP.

AVERAGE WEIGHT OF TABLETS (in mg)	MAXIMUM PERCENTAGE DIFFERENCE ALLOWED
80mg or less	10
More than 80mg and less than 250mg	7.5
250mg or more	5

Take the weight of individual tablets and check if all the tablets are lying with in the limits.

Select the tablets only if no more than two tablets are out of percentage limit and if no tablet differs by more than two times the percentage limit, otherwise reject the tablets.

Adjust the desired weight of the tablets in the Compression Machine by moving weight adjustment cam clockwise or anticlockwise accordingly as per the MFR of Compression Machine.

Re-check the weight of tablets for further adjustment, if any.

Thickness of Tablets: Thickness of the tablets should be determined by means of the vernier caliper. The thickness of the tablet should be checked whenever weight adjustments are made.

Hardness of the tablets: The equipment used is the ‘Monsanto’ type hardness tester. Hardness of the compressed tablets should be checked at regular interval to determine the need for pressure adjustments on the tableting machine.

Hardness of tablets varies between : 2-4 Kg/cm².

Friability: ‘Roche Friabilator’ is used for measuring the Friability. The instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping.

Adjust the instrument to 25 RPM before adding the tablets.

Weigh 20 Tablets on calibrated balance. Transfer the tablets in the plastic chamber. Close the drum tightly.

Switch on the apparatus. Operate the Friabilator for 100 revolutions.

De-dust and reweigh the tablets. Loss in weight indicates the ability of tablets to withstand the wear.

Take 10 tablets to check the friability, when the average weight of tablet is 1g or more than

Friability Limit = Less than 1.0%

Disintegration Test: Disintegration is the time required for the group of tablets to disintegrate into the particles. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.

The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

Place the tablets in each of 6 tubes along with a plastic disc over the tablets.

The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.

Switch on the apparatus to move the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

When the tablets have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the tablets and record the same in Batch Manufacturing Record.

If one or two tablets fail to disintegrate, the test is to be repeated using 12 tablets.

Disintegration Time of uncoated tablets= Not more than 15 minutes

Disintegration Time of coated tablets= Not more than 30 minutes

Tablets taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.

Inspection, sorting of rejected tablets should be done as per SOP.

The strips and cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

Tablets, MASTER FORMULAS

Iodine, Potassium Iodide Solution

August 25, 2020February 11, 2023 ABHA

Iodine, Potassium Iodide Solution

PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOP: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QA Manager, QC Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

Master Copy: Manager Quality Assurance

Copy No. 1: Production Pharmacist

Copy No. 2: Manager Quality Control

Copy No. 3: External Preparation Section

PRODUCT NAME: Iodine, Potassium Iodide Solution	BATCH SIZE: 200 KGS
PRODUCT REFERENCE CODE:	UNIT SIZE: 20g / 18 ml
GENERIC NAME: N.A.	PACK SIZE: 160 x 20 gm / 18 ml
DOSAGE FORM: solution	STRENGTH: N.A.
DEPARTMENT: LIQUID DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Iodine I.P. 1 g

Potassium Iodide I.P. 2 g

Tannic Acid I.P. 1.5 g

Menthol I.P. 0.25% w/v

Camphor I.P. 0.20% w/v

Thymol I.P. 0.25% w/v

Glycerin I.P. 70% w/v

Purified Water 100 g

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Charging Tank E-02 (1200 Lts)
2	Storage Tank
3	Manual Bottle Filling Machine
4	Semi Automatic Bottle Sealing Machine
5	Semi Automatic Bottle Labelling Machine
6.	Shrink Packing machine

RAW MATERIALS:

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1	camphor	I.P.	0.400	25	0.500 Kgs
2	GLYCERINE	I.P.	140.000		140.000 Kgs
3	IODINE	I.P.	2.000	10	2.200 Kgs
4	MENTHOL	I.P.	0.500	20	0.600 Kgs
5	POTASSIUM IODIDE	I.P.	4.000	10	4.400 Kgs
6	SPIRIT CHLOROFORM	I.P.	45.000		45.000 Lts
7	TANNIC ACID	I.P.	3.000	10	3.300 Kgs
8	THYMOL	I.P.	0.500	20	0.600 Kgs

PACKING MATERIALS:

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	20 ML AMBER ROUND BTLS	10000.000		10000.000 Nos.
2.	ADH. TAPE ROLL BROWN	2.000		2.000 Nos.
3.	GUM ACCACIA	1.000		1.000 Nos.
4.	C. BOX K-25	62.500		62.500 Nos.
5.	PL. INNER PLUG (DRY SYRUP)	10000.000		10000.000 Nos.
6.	P.P. CAPS 25 MM (RUBBER)	10000.000		10000.000 Nos.
7.	SHRINK FILM 220 X 220 MM	500.000		500.000 Nos.
8.	UNIT CARTONS SENSOSEAL 18 ML	10000.000	2.000	10002.000 Nos.
9.	LABELS SENSOSEAL 18 ML	10062.500	3.000	10065.500 Nos.

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 18 ml.

Volume variation limit allowed in each filled Bottle is 18 ml to 20 ml.

Make up the final volume of the solution accurately.

Transfer the solution from charging tank to storage tank after complete charging of batch.

Yield:

Theoretical Yield is 10000 Bottles.

Expected Practical Yield is 10000 + 2% Bottles.

Packing Details:

Wash the bottles manually.

Transfer the lotion from charging tank to manual bottle filling machine for filling of the bottle as per its SOP.

Fill 100 ml of solution in 100ml Amber coloured glass bottles.

Sealing of filled bottle is done on semi-automatic bottle sealing machine as per its SOP.

Label each filled and sealed bottle by Labelling machine as per its SOP.

Make a group of 20 bottles packed in unit cartons.

Wrap this film in thermoplast film and shrink pack it by operating shrink packing machine as per its SOP.

Pack such 8 shrinked packets in the Corrugated box. Thus each corrugated box contains 8 X 20 X 20 gm/ 18 ml filled and sealed bottles.

Seal each corrugated box with adhesive tape on both side and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

To 140 kg of Glycerin in Charging Tank Start stirring.

Dissolve 4.40 kg of Potassium Iodide in 25 Ltrs of purified water and add 2.2 kg of Iodine to it. And let it. Mix well. Add this to the above tank.

Dissolve 3.30 kg of Tannic Acid in 25 ltrs of purified water and to the bulk batch.

Dissolve 0.500 kg of Camphor, 0.600 kg of Thymol, 0.600 kg of Menthol in45 ltrs of Spirit Chloroform.

And stir well for 30 minutes.

Send the sample to Quality Control Department for bulk testing.

Transfer this to the Storage tank for filling.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Final volume should be made as per MFR using correct dipstick in the Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Only after receiving the Bulk Test Report from Q.C. Dept. start the filling and sealing stage.

The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Limit for Volume Variation: Volume claimed on the label + 2ml

Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.

The labels and cartons should be checked thoroughly for proper batch coding.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

Oral Liquid, MASTER FORMULAS

Tannic Acid, Menthol solution

August 25, 2020February 11, 2023 ABHA

Tannic Acid, Menthol solution

PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

COPY ISSUED TO:

Master Copy: Manager Quality Assurance

Copy No. 1: Production Pharmacist

Copy No. 2: Manager Quality Control

Copy No. 3: External Preparation Section

PRODUCT NAME: Tannic Acid, Menthol solution	BATCH SIZE: 200 KGS
PRODUCT REFERENCE CODE:	UNIT SIZE: 20g / 18 ml
GENERIC NAME: N.A.	PACK SIZE: 160 x 20 gm / 18 ml
DOSAGE FORM: solution	STRENGTH: N.A.
DEPARTMENT: EXTERNAL LIQUID DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Iodine B.P. 1 g

Potassium Iodide B.P. 2 g

Tannic Acid B.P. 1.5 g

Menthol B.P. 0.25% w/v

Camphor B.P. 0.20% w/v

Thymol B.P. 0.25% w/v

Glycerin B.P. 70% w/v

Purified Water 100 g

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Charging Tank E-02 (1200 Lts)
2	Storage Tank
3	Manual Bottle Filling Machine
4	Semi Automatic Bottle Sealing Machine
5	Semi Automatic Bottle Labelling Machine
6	Shrink Packing machine

RAW MATERIALS:

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1	camphor	B.P.	0.400	25	0.500 Kgs
2	GLYCERINE	B.P.	140.000		140.000 Kgs
3	IODINE	B.P.	2.000	10	2.200 Kgs
4	MENTHOL	B.P.	0.500	20	0.600 Kgs
5	POTASSIUM IODIDE	B.P.	4.000	10	4.400 Kgs
6	SPIRIT CHLOROFORM	B.P.	45.000		45.000 Lts
7	TANNIC ACID	B.P.	3.000	10	3.300 Kgs
8	THYMOL	B.P.	0.500	20	0.600 Kgs

PACKING MATERIALS:

Sr.No.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	20 ML AMBER ROUND BTLS	10000.000		10000.000 Nos.
2.	ADH. TAPE ROLL BROWN	2.000		2.000 Nos.
3.	GUM ACCACIA	1.000		1.000 Nos.
4.	C. BOX K-25	62.500		62.500 Nos.
5.	PL. INNER PLUG (DRY SYRUP)	10000.000		10000.000 Nos.
6.	P.P. CAPS 25 MM (RUBBER)	10000.000		10000.000 Nos.
7.	SHRINK FILM 220 X 220 MM	500.000		500.000 Nos.
8.	UNIT CARTONS TOOTH HEAL 18 ML	10000.000	2.000	10002.000 Nos.
9.	LABELS TOOTH HEAL 18 ML	10062.500	3.000	10065.500 Nos.

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 18 ml.

Volume variation limit allowed in each filled Bottle is 18 ml to 19 ml.

Make up the final volume of the solution accurately.

Transfer the solution from charging tank to storage tank after complete charging of batch.

Yield:

Theoretical Yield is 10000 Bottles.

Expected Practical Yield is 10000 + 2% Bottles.

Packing Details:

Wash the bottles manually.

Transfer the lotion from charging tank to manual bottle filling machine for filling of the bottle as per its SOP.

Fill 18 ml of solution in 20ml Amber coloured glass bottles.

Sealing of filled bottle is done on semi-automatic bottle sealing machine as per its SOP.

Label each filled and sealed bottle by Labelling machine as per its SOP.

Make a group of 20 bottles packed in unit cartons.

Wrap this film in thermoplastic film and shrink pack it by operating shrink packing machine as per it SOP.

Pack such 8 shrinked packets in the Corrugated box. Thus each corrugated box contains 8 X 20 X 20 gm/18 ml filled and sealed bottles.

Seal each corrugated box with adhesive tape on both side and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

To 140 kg of Glycerin in Charging Tank Start stirring.

Dissolve 4.40 kg of Potassium Iodide in 25 Ltrs of purified water and add 2.2 kg of Iodine to it. And let it. Mix well. Add this to the above tank.

Dissolve 3.30 kg of Tannic Acid in 25 ltrs of purified water and to the bulk batch.

Dissolve 0.500 kg of Camphor, 0.600 kg of Thymol, 0.600 kg of Menthol in45 ltrs of Spirit Chloroform.

And stir well for 30 minutes.

Send the sample to Quality Control Department for bulk testing.

Transfer this to the Storage tank for filling.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Final volume should be made as per MFR using correct dipstick in the Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Only after receiving the Bulk Test Report from Q.C. Dept. start filling and sealing stage.

The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Limit for Volume Variation: Volume claimed on the label + 1.0 ml

Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.

The labels and cartons should be checked thoroughly for proper batch coding.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance.

Oral Liquid, MASTER FORMULAS

Cetirizine Dihydrochloride 10 mg Tablet

August 24, 2020February 11, 2023 ABHA

Cetirizine Dihydrochloride 10 mg Tablet

PURPOSE:
This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:
This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY:
It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

1. Master Copy: Manager Quality Assurance
2. Copy No. 1: Production Pharmacist
3. Copy No. 2: Manager Quality Control
4. Copy No. 3: Tablet Section

PRODUCT NAME: Cetirizine Dihydrochloride Tablet	BATCH SIZE: 20.0 LAC
PRODUCT REFERENCE CODE:	UNIT SIZE: 10 x 30
GENERIC NAME: CETIRIZINE DI HYDROCHLORIDE TABLET	PACK SIZE: 62 x 10 x 30
DOSAGE FORM: TABLET	STRENGTH: N.A.
DEPARTMENT: TABLET DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each film coated Tablet contains:

Cetirizine Dihydrochloride B.P. 10 mg

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Steam Jacketed Starch Paste Preparation Tank
2	Sifter Machine – I
3	Roto Cube Blender –I
4	Rapid Mixer Granulator
5	Multi Mill
6	Fluidized Bed Drier
7	Oscillating Granulator
8	Sifter Machine – II
9	Roto Cube Blender – II
10	Tablet Compression Machine 27 Stations
11	Dedusting Machine
12	Tablet Inspection Machine
13	Rapid Coat Tablet Coating Machine
14	Single Track Blister Packing Machine

RAW MATERIAL:-

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	Aerosil	I.P	2.000		2.000 kg.
2.	Cetirizine Di Hydrochloride	B.P.	20.000	10%	22.000 kg.
3.	Di Calcium Phosphate	I.P.	100.000		100.000 kg.
4.	Instacoat White Aqua-111	I.P.	6.260		6.260 kg
5.	Lactose	I.P.	20.000		20.000 kg.
6.	Magnesium Stearate	I.P.	4.000		4.000 kg.
7.	PVPK-30	I.P.	1.000		1.000 kg.
8.	Sodium Benzoate	I.P.	2.000		2.000 kg.
9.	Starch	I.P.	132.600		132.600 kg.
10.	Starch	I.P.	12.000		12.000 kg.
11.	Starch	I.P.	10.000		10.000 kg.
12.	Talcum	I.P.	10.000		10.000 kg.

PACKING MATERIAL:-

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	92 MM CLEAR (PVC)	160.000		160.000 KG
2.	ADHESIVE TAPE ROLL BROWN	3.000		3.000 KG
3.	CELLO TAPE	8.000		8.000 KG
4	ALUMINIUM FOIL – 3 TRACK (CETRAMAC TABS)	35.000		35.000 KG
5	UNIT CARTON (30 X 10) (CETRAMAC TABS)	6666.000	2.000	6668.000 NOS
6	CORRUGATED BOX M- 07	111.000		111.000 NOS

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.
Average weight of each Tablet is 150 milligrams.
Weight Variation Limit for average weight of 20 tablets is +5 %.
Friability limit for 20 Tablets is not more than 1.0 %.
Hardness of the Tablets varies between 2 – 4 kg/cm².
Disintegration time for each Tablet is not more than 30 minutes.
Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 25˚C.
Perform the coating of the tablets at temperature not more than 25˚ C and humidity not more than 40%.

Yield:

Theoretical Yield is 20.0 Lac Tablets.
Expected Practical Yield is 20.0 Lac + 2% Tablets.

Packing Details:

Use PVC clear 92 mm and Aluminium foil for blister packing.
Blister Pack the inspected and De-dusted tablets by using Single Track Blister Packing Machine as per its SOP .
Put 10 strips each containing 30 tablets in each carton.
Seal the each unit carton from both ends with cello tape.
Pack the 62 cartons in specified corrugated box to give a pack size of 62 x 10 x 30 tablets.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

1.Preparation of Starch Paste:

Prepare the starch paste in the manner given below using Steam Jacketed Starch Paste Preparation Tank by operating it as per its SOP.

Dissolve 2.0 kg of Sodium Benzoate in 4 Ltrs of Purified Water and stir continuously.
Add 12.0 kg of Starch in 8 Ltrs Purified water and stir continuously to make slurry.
Dissolve 1.0 kg of PVPK – 30 in 2 Ltrs of Purified water prepare solution of PVPK – 30..
To this add the solution of sodium benzoate and starch slurry with constant stirring to get a uniform paste.

Sifting:

Fit Stainless Steel Sieve # 40 on the Sifter-I as per its SOP. Sift the all ingredients through it and collect separately in Stainless Steel Container.

Blending:

Blend the following ingredients using Roto Cube Blender by operating it as per its SOP for 30 minutes and collect in Stainless Steel Container.

132.600 kgs of Starch.
100.0 kgs of Dicalcium Phosphate.
20.0 kgs of Lactose
20.0 kgs of Cetrizine Hydrochloride

Wet Granulation:

Mix the above blended ingredients with the Starch paste using Rapid Mixer Granulator by operating it as per its SOP .Add starch paste in such a manner by following the procedure given below so as to achieve proper wetting.

Divide the blended powder in ten equal parts.
Divide the prepared starch paste in ten equal parts.
Mix the one part of blended powder and starch paste together in Rapid Mixer Granulator.
Similarly mix the rest of the parts in same manner.

. Wet Screening:

Pass the wet dough through a Multi Mill by operating it as per its SOP to convert the moist mass into coarse, granular aggregates.

Drying:

Dry the granules in Fluidized Bed Drier by operating it as per its SOP at temperature 50⁰ – 60⁰C for 30 minutes. Cool the granules to achieve room temperature.

Sifting:

Fit Stainless Steel Sieve # 20 on the Sifter-II as per its SOP. Sift all granules through it and collect in Stainless Steel Container. Break the oversized granules left over the mesh in Oscillating Granulator by operating it as per its SOP and resift them.

Check the total weight of dried granules. Determine the loss on drying and percentage yield of dried granules.
8. Lubrication:

Lubricate the sifted granules along the following ingredients through Roto Cube Blender by operating it as per its SOP for 15 minutes and collect in Stainless Steel Container.

2.0 kgs of Aerosil
4.0 kgs of Magnesium Stearate
10.0 kgs of Starch
10.0kgs of Talcum

Send the granules for bulk testing to Quality Control Department for assay of Active Ingredients.

Compression:

Shift all the granules for compression to Tablet Compression Machine 27 Stations by operating it as per its SOP and collect the compressed tablets in Stainless Steel Container.

Tablet Inspection:

Transfer the all tablets to tablet inspection machine and sort out the defected tablet by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

Coating of the tablet:

6.260 kgs of Instacoat white Aqua-111 .Now start coating of the tablets by using Rapid Cota Tablet Coating Machine by operating it as per its SOP and collect the coated tablets in Stainless Steel Container.

Tablet Inspection:

Transfer all coated tablets to tablet inspection machine and sort out the defected tablet by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

Blister Packing:

Shift the inspected tablets to blister section and blister pack them using Single Track Blister Packing Machine by operating it as per its SOP

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
Humidity and temperature should be maintained during the compression of thermolabile products.
Sample of dried granules should be sent to Quality Control Department for the determination of Moisture content.
The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
Bulk sample should be sent for analysis to Quality Control Department before starting compression of tablets.
Weight Variation: I) Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the Assistant Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.
Out-of-limit tablets should be checked by Weight Variation Method as given below:
Take the average weight of 20 tablets on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

AVERAGE WEIGHT OF TABLETS (in mg)	MAXIMUM PERCENTAGE DIFFERENCE ALLOWED
80mg or less	10
More than 80mg and less than 250mg	7.5
250mg or more	5

ii) Take the weight of individual tablets and check if all the tablets are lying with in the limits.

iii) Select the tablets only if no more than two tablets are out of percentage limit and if no tablet differs by more than two times the percentage limit, otherwise reject the tablets.

iv) Adjust the desired weight of the tablets in the Compression Machine by moving weight adjustment cam clockwise or anticlockwise accordingly as per the Standard Operating Procedure of Compression Machine.
v) Re-check the weight of tablets for further adjustment, if any.

Thickness of Tablets:

Thickness of the tablets should be determined by means of the vernier caliper. The thickness of the tablet should be checked whenever weight adjustments are made.

Hardness of the tablets:

The equipment used is the ‘Monsanto’ type hardness tester. Hardness of the compressed tablets should be checked at regular interval to determine the need for pressure adjustments on the tableting machine.

Hardness of tablets varies between: 2 – 4 Kg/cm².

Friability:
- ‘Roche Friabilator’ is used for measuring the Friability. The instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping.
- Adjust the instrument to 25 RPM before adding the tablets.
- Weigh 20 Tablets on calibrated balance. Transfer the tablets in the plastic chamber. Close the drum tightly.
- Switch on the apparatus. Operate the Friabilator for 100 revolutions.
- De-dust and reweigh the tablets. Loss in weight indicates the ability of tablets to withstand the wear.
- Take 10 tablets to check the friability, when the average weight of tablet is 1g or more than 1g.

Friability Limit = Less than 1.0%

Disintegration Test:

i) Disintegration is the time required for the group of tablets to disintegrate into the particles. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
ii) The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

iii) Place the tablets in each of 6 tubes along with a plastic disc over the tablets.

iv) The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
v) Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is at least 2.5cm below the surface of liquid when the basket is at highest position.
vi) Switch on the apparatus to move the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

When the tablets have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the tablets and record the same in Batch Manufacturing Record.
If one or two tablets fail to disintegrate, the test is to be repeated using 12 tablets.

Disintegration Time of uncoated tablets= Not more than 15 minutes

Disintegration Time of coated tablets= Not more than 30 minutes

Tablets taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
Inspection, sorting of rejected tablets should be done as per SOP.
The strips and cartons should be checked thoroughly for proper batch coding.
Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.
Intimation should be sent to Quality Control Department for finished product sampling and testing.
After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.
It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

Tablets, MASTER FORMULAS

Povidone – Iodine Liquid Solution

August 23, 2020February 11, 2023 ABHA

Povidone – Iodine Liquid

PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

COPY ISSUED TO:

Master Copy : Manager Quality Assurance

Copy No. 1 : Production Pharmacist

Copy No. 2 : Manager Quality Control

Copy No. 3 : External Preparation Section

PRODUCT NAME: Povidone – Iodine Liquid	BATCH SIZE: 1000 LTRS.
PRODUCT REFERENCE CODE:	UNIT SIZE: 100ml
GENERIC NAME: POVIDONE-IODINE SOLUTION U.S.P.	PACK SIZE: 72 x 100 ML
DOSAGE FORM: SEMI LIQUID	STRENGTH: N.A.
DEPARTMENT: LIQUID DEPARTMENT	EXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Povidone – Iodine U.S.P. 5% w/v

(Available Iodine 0.5 % w/v)

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Charging Tank – E02(1200 Lts)
2	Storage Tank – III – 5000 Ltrs
3	Manual Bottle Filling Machine
4	Semi Auto Bottle Sealing Machine
5	Semi Auto Labelling Machine
6	Shrink Packing Machine

RAW MATERIALS:

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	BENZYL ALCOHOL	U.S.P.	20.0000		20.000 KGS
2	POVIDON IODINE	U.S.P.	50.000	10.00	55.000 KGS

PACKING MATERIALS:

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1	100 ML AMBER RD. BOTLS	10000.000		10000.000 NOS
2	ADHESIVE TAPE ROLL BROWN	4.000		4.000 NOS
3	CORRUGARED BOX E-24	152.000		152.000 NOS
4	GUM ACCACIA	1.100		1.100 KGS
5	P.P CAPS 25 MM	10000.000		10000.000 NOS
6	LABELS	10142.000	3.000	10145.000 NOS
7	UNIT CARTON	10000.000	2.000	10002.000
8	SHRINK FILM 240 X 220 MM	1667.000		1670.000
9	HANDLE WITH CARE STICKER	138.000		145.000

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 100 ml.

Volume variation limit allowed in each filled Bottle is 100 ml to 102 ml.

Make up the final volume of the solution accurately.

Transfer the solution from charging tank to storage tank after complete charging of batch.

Yield:

Theoretical Yield is 10000 Bottles.

Expected Practical Yield is 10000 + 2% Bottles.

Packing Details:

Wash the bottles manually.

Transfer the lotion from charging tank to manual bottle filling machine for filling of the bottle as per its SOP.

Fill 100 ml of solution in 100ml Amber colored glass bottles.

Sealing of filled bottle is done on semi-automatic bottle sealing machine as per its SOP.

Label each filled and sealed bottle manually.

Pack such 72 labeled bottles in a specified Corrugated box .

Seal each corrugated box with adhesive tape on both side

MANUFACTURING PROCESS:

To the charging tank add 55.0 kgs of Povidone Iodine.

Add 300 Ltrs of purified water to it and let it to wet for overnight.

Add 20.0 kgs of Benzyl Alcohol to it.

And stir well for 90 minutes.

Transfer this to the Storage tank .

Send the sample to Quality Control Department for bulk testing.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Final volume should be made as per MFR using correct dipstick in the Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Only after receiving the Bulk Test Report from Q.C. Dept. start filling and sealing stage.

The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Oral Liquid, MASTER FORMULAS

Povidone Iodine Ointments

August 23, 2020February 11, 2023 ABHA

Povidone Iodine Oinment

PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

COPY ISSUED TO:

Master Copy : Manager Quality Assurance

Copy No. 1 : Production Pharmacist

Copy No . 2 : Manager Quality Control

Copy No. 3 : Ointment Section

PRODUCT NAME: Povidone Iodine Oinment	BATCH SIZE: 300 KG
PRODUCT REFERENCE CODE:	UNIT SIZE: 15 g
GENERIC NAME: N.A.	PACK SIZE: 36 ´ 12 ´ 15g
DOSAGE FORM: OINTMENT	STRENGTH: N.A.
DEPARTMENT: OINTMENT DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Povidone Iodine	IP	5% w/w
(Available Iodine 0.5% w/w)

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	CLEANING AS PER SOP NO.	ASSEMBLING AS PER SOP NO.
1	Wax Vessel
2	Water Vessel
3	Mixing Vessel
4	Storage Container-I (500 Kg)
5	Semiautomatic Aluminium Tube Filling & Crimping Machine

RAW MATERIALS:-

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1	PEG – 4000	I.P.	84.500		84.500 KGS
2	PEG – 400	I.P.	194.000		194.000 KGS
3	POVIDONE IDODINE	I.P.	15.000	15.00	17.250 KG
4	P.G.	I.P.	4.500		4.500 KG

PACKING MATERIALS: –

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1	ADHERE TAPE ROLL BROWN	1.000		1.000 NOS
2	CELLO TAPE	2.000		2.000 NOS
3	ALUMINIUM TUBE – 15 G	20000.000		2000.000 NOS
4	UNIT CARTON	20000.000	3.000	20003.000 NOS
5	OUTER CARTON	1666.000	2.000	1668.000 NOS
6	CORRUGATED BOX S – 11	46.000		46.000 NOS

MANUFACTURING SPECIFICATION:

Average fill of each Tube is 15 grams.

Weight variation limit allowed in each filled Tube is + 200 mg.

Melt the waxes at the maintained temperature 70⁰

The temperature of primary area should not exceed 30˚C.

Yield:

Theoretical Yield is 20000 Tubes.

Expected Practical Yield is 20000 + 2% Tube.

Packing Details:

Transfer the Ointment from storage tank to Aluminium Tube Filling & Crimping Machine and start filling and then Crimping of the tubes as per its SOP.

Pack the filled tubes in unit carton.

Pack such 12 tubes in each outer carton.

Seal the outer carton with cello tape.

Pack the 36 outer cartons in specified corrugated box to give a pack size of 36 x 12 x 15g tubes.

Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label

MANUFACTURING PROCESS:

Melt 84.5 kg of PEG- 4000 and 97.0 kg of PEG-400 in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 70⁰

Filter and transfer the melted waxes through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine as per its SOP.

Take 97.0 kg of PEG- 400 in water Vessel and dissolve 17.250 kg of Povidone Iodine in it. Also add 4.5 kg of Propylene Glycol to it.

Cool PEG-4000 and PEG- 400 to 45˚ C in mixing vessel and transfer the mixture prepared in step no. 3 to it.

Mix for 3 hours and cool it to room temperature while running the water in the jacket of mixing vessel.

Send the sample to Quality Control Department for bulk testing.

After approval from Quality Control Department, transfer the cream to the storage tank

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

The total weight of bulk ointment / cream should be checked in the presence of Manufacturing Chemist and record the same in Batch Manufacturing Record.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

While the tube filling operation is on, the Manufacturing Chemist should check weight of net filled quantity per tube at the interval of 30 minutes by checking the tare weight of empty tube and gross weight of the filled tube. Record for the same should be kept in Batch Manufacturing Record.

The ‘fill weight’ of ointment or cream per tube should not be less than the labelled amount.

Limit for Weight Variation: Weight claimed on the carton + 200 mg

Manufacturing Chemist will also ensure that the crimping of the filled Aluminium tubes, sealing of plastic tubes is appropriate and embossing of batch number and manufacturing date is conspicuous. Also the quality of embossing will be controlled by adjusting pressure exerted by the jaws, so that pinholes are not developed on the embossed letters / numbers.

The inner and outer cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of inner cartons are being packed in each outer cartons and also the correct number of outer cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of filling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should be commenced only after getting the ‘Line Clearance’ of the previous product, from the IPQA.

Ointments

Gamma Benzene Hexachloride Liquid

August 23, 2020February 11, 2023 ABHA

Gamma Benzene Hexachloride Liquid

PURPOSE: This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

COPY ISSUED TO:

Master Copy : Manager Quality Assurance

Copy No. 1 : Production Pharmacist

Copy No. 2 : Manager Quality Control

Copy No. 3 : External Preparation Section

PRODUCT NAME: Gamma Benzene Hexachloride Liquid	BATCH SIZE: 4000 LTRS.
PRODUCT REFERENCE CODE:	UNIT SIZE: 100ml
GENERIC NAME: GAMMA BENZENE HEXACHLORIDE LOTION I.P.	PACK SIZE: 12 x 8 x 100 ML
DOSAGE FORM: SEMI LIQUID	STRENGTH: N.A.
DEPARTMENT: EXTERNAL PREPARATION	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Gamma Benzene Hexachloride U.S.P. 1% w/v

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Charging Tank (1200 Lts)
2	Storage Tank – 5000 Ltrs
3	Manual Bottle Filling Machine
4	Semi Automatic Bottle Sealing Machine
5	Semi Automatic Bottle Labelling Machine

RAW MATERIALS:

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1	CETOCETYL ALCOHOL	I.P.	144.000	–	144.000 KGS
2	LAVENDER OIL	F.G	20.000	–	20.000 LTR
3	LINDANE (GAMMA BENZENE HEXACHLORIDE)	U.S.P	40.000	–	40.00 KGS
4	LIQUI D PARAFFIN LIGHT	I.P.	200.000	–	200.000 KGS
5	S.L.S.	I.P.	16.000	–	16.000 KGS

PACKING MATERIALS:

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	100 ML PLASTIC FLAT BTLS	10000.000	–	10000.000 NOS
2	6 X 20 MM FLIP TOP PL. CAPS	10000.000	–	10000.000 NOS
3	ADHESIVE TAPE ROLL BROWN	3.000	–	3.000 NOS
4	CELLO TAPE	10000.000	–	10000.000 NOS
5	CORRUGATED BOX S -18	104.000	–	104.000 NOS
6	OUTER	837.000	2.000	839.000 NOS
7	LABEL FRONT	10104.000	3.000	10107.000 NOS
8	LABEL BACK	10104.000	3.000	10108.000 NOS

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 100 ml.

Volume variation limit allowed in each filled Bottle is 100 ml to 102 ml.

Make up the final volume accurately.

Transfer the batch from charging tank to storage tank after complete charging of batch.Prepare the batch in 4 lots of same size i.e. 4 ´ 1000 Ltrs.

Prepare second, third and fourth lot only after the completion of first batch.

Prepare the rest of the lots in the same manner repeating the procedure of lot one and send the sample for bulk testing.

Yield:

Theoretical Yield is 40000 Bottles.

Expected Practical Yield is 40000 + 2% Bottles.

Packing Details:

Wash the bottles manually.

Transfer the lotion from charging tank to Manual Bottle Filling and Sealing Machine for filling of the bottles as per its SOP.

Fill 100 ml of lotion in white plastic flat bottle.

Label every filled and closed bottle, from both front and backside, manually.

Pack each filled and labelled bottle in unit carton individually.

Make a group of 12 bottles packed in one outer carton.

Pack such 8 outer boxes in the Corrugated box Thus each corrugated box contains 8 x 12 x 100 filled and sealed bottles.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Add 880 kgs of purified water in the steam jacketed charging tank and slowly heat at 70⁰C by running the steam in the jacket of the tank. Start stirring in the tank.

Now add 36.0 kgs of Cetocetyl Alcohol in charging tank and heat it to 70⁰C and add 4.0 kgs of S.L.S. to it. Mix properly by allowing stirring and transfer this Emulsifying Wax to charging tank under constant stirring.

Heat 50.0 kgs of Liquid Paraffin to 65⁰C in Stainless Steel Container and dissolve 10.0 kgs of Lindane to it. Stir it to dissolve completely and transfer to charging tank under constant stirring.

Stop the stirring and cool the whole batch to room temperature.

Add 5.0 kgs of Lavender oil to the same batch.

Transfer this to the Storage tank.