Cleaning Validation Products Grouping Matrix Tablets Capsules and PPS

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In the following sections, a general presentation of product grouping along with the information about their APIs, excipients, therapeutic dose, maximum daily dosage, solubility, and toxicity is presented. The basic purpose of products grouping is to determine the representative or worst-case products manufactured in a particular equipment train.

While generating the CVMP, it is very important to have a clear overview of all the product types and knowledge of their constituents. Based on this information and with the help of equipment trains in the following sections, it would be a straightforward process to identify the worst-case products for each equipment train.

The information is general and is only meant to explain how the step-by-step generation of Master Validation Plan (MVP) should be processed.

17.1 Product Grouping Matrix (Solid Dosage) 17.1.1 Tablets

Maximum Therapeutic Usage per

Product

Batch Size

Ingredients

Dose

Day

Solubility

Toxicity Level LD50

Thidoxine tablets

450,000

Thiamine

100 mg

440 mg

2

LDjo >10,000 mg/kg oral rat

Pyridoxine

200 mg

840 mg

2

LD50 5500 mg/kg oral mouse

Lactose

2

monohydrates

PVP-90

1

Magnesium

7

stearate

Avicel PH-112

7

Cyanocobalamine

200 mg

1.208 mg

4

LD50 2 g/kg oral mouse

Aceclofenac F/C

600,000

Aceclofenac

100 mg

200 mg

7

tablets

(120 kg)

Lactose Maize starch

S

continued S1

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Your Company's Logo

Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility

Toxicity Level LD50

PVP-K-30

2

Avicel

7

Magnesium

7

stearate

Paracetamol

1,000,000

Paracetamol

500 mg

4 g

3

LD50 2404 mg/kg

500 mg tablets

tablets

oral rat

(640 kg)

Maize starch

3

PVP-K-30

2

Potassium sorbate

1

Glycerol

5

Albendazole

175,000

Albendazole

400 mg

800 mg

7

LD50 2400 mg/kg

tablets

(103.25 kg)

oral rat

Maize starch

3

Lactose

2

PVP-K-30

2

Magnesium

7

stearate

Avicel

7

Primogel

6

Amiodarone

500,000

Amiodarone HCl

200 mg

600 mg

6

LD50 2600 mg/kg

200 mg tablets

(175 kg)

oral rat

Lactose

2

PVP-K-30

2

Magnesium

7

stearate

Aerosil 200

7

Maize starch

3

Bromocryptin

1,000,000

Bromocryptin

2.5 mg

7.5 mg

7

2.5 mg tablets

(110 kg)

Lactose

2

monohydrates

Maize starch

3

Sodium EDTA

3

Magnesium

7

stearate

Aerosil 200

7

Ketotifen 1.0 mg

500,000

Ketotifen fumarate

1 mg

2 mg

5

LD50 360 mg/kg

tablets

tablets

oral rat

(57.5 kg)

Lactose

2

monohydrates

Maize starch

3

Your Company's Logo

Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility

Toxicity Level LD^

PVP-K-30

2

Magnesium

7

stearate

Avicel PH-102

7

Oxybuprocaine

100,000

Oxybuprocaine

0.2 mg

L2 mg

1

Lozenges

(124.5 kg)

HCl

Cetyl pyridinium

1.0 mg

6.0 mg

1

Tyrothricin

4.0 mg

24 mg

Menthol

7

Aerosil 200

7

Magnesium

7

stearate

Sorbitol

4

Dextrose

Betamethasone

1,000,000

Betamethasone

0.5 mg

5 mg

7

LD50 3.0 g/kg

0.5 mg tablets

tablets

oral rat

(110 kg)

Magnesium

7

stearate

Lactose

2

monohydrates

Maize starch

3

Salbutamol 4 mg

1,000,000

Salbutamol

4 mg

16 mg

2

LD50 1950 mg/kg

tablets

tablets

oral mouse; LD50

(120 kg)

2500 mg/kg

oral rat

Lactose

2

monohydrates

Maize starch

3

Magnesium

7

stearate

Captopril 50 mg

500,000

Captopril

2

LD50 4245 mg/kg

tablets

tablets

oral rat

Lactose spray dried

2

Avicel PH-102

7

Stearic acid

7

Starch 1500

5

Propranolol 40 mg

1,000,000

Propranolol HCl

40 mg

120 mg

3

Not known

tablets

tablets

(200 kg)

Maize starch

3

Lactose

2

Magnesium

7

stearate

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Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility

Toxicity Level LD50

Stearic acid

7

Avicel

7

Cetrizine 10 mg

800,000

Cetrizine HCl

10 mg

10 mg

2

LD50 703 mg/kg

F/C tablets

tablets

oral rat

(104 kg)

Maize starch

3

Lactose

2

PVP-K-30

2

Magnesium

7

stearate

Chlorpheniramine

2,000,000

Chlorpheniramine

4 mg

24 mg/

2

LD50 130 mg/kg

tablets

tablets

maleate

day

oral mouse; LD50

300 mg/kg oral rat

Lactose

2

monohydrates

Maize starch

3

Magnesium

7

stearate

Cimetidin 400 mg

225,000

Cimetidin

800 mg

1600 mg

5

LD50 5000 mg/kg

tablets

tablets

oral rat

(123.75 kg)

Ciprofloxacin

150,000

Ciprofloxacin HCl

500 mg

500 mg

4

LD50 5000 mg/kg

500 mg F/C

tablets

oral rat; LD50

tablets

(115.5 kg)

5000 mg/kg

oral mouse

Kolidone CL

7

Primogel

6

PVP-K-30

2

Magnesium

7

stearate

Avicel PH-102

7

Aerosil 200

7

Clarithromycin

125,000

Clarithromycin

500 mg

1500 mg

7

500 mg tablets

tablets

(112 kg)

Avicel PH-102

7

PVP-K-30

2

Aerosil 200

7

Starch 1500

5

Stearic acid

7

Diclofenac 50 mg

2,000,000

Diclofenac sodium

50 mg

150 mg

4

LD50 150 mg/kg

tablets

tablets

oral rat

(438 kg)

Lactose

2

monohydrates

Your Company's Logo

Your Company's Name

Your Company's Name

Product

Batch Size

Ingredients

Maximum Therapeutic Usage per

Dose Day Solubility Toxicity Level LD50

Product

Batch Size

Ingredients

Maximum Therapeutic Usage per

Dose Day Solubility Toxicity Level LD50

Maize starch

3

Magnesium

7

stearate

Avicel

7

PVP-K-30

2

Aerosil 200

7

Metformin 100 mg

100,000

Metformin HCl

1000 mg 1000 mg

2

LD50 4000 mg/kg

F/C tablets

tablets

oral rat

(11.5 kg)

Starch 1500

5

Maize starch

3

PVP-K-30

2

PVP-K-90

2

Avicel PH-101

7

Magnesium

7

stearate

Diazepam 5 mg

1,000,000

Diazepam

5 mg 60 mg

6

LD50 48 mg/kg

tablets

tablets

oral mouse

(120 kg)

Lactose

2

monohydrates

Maize starch

3

Magnesium

7

stearate

PVP-K-30

2

Dimenhydrinate

1,000,000

Dimenhydrinate

50 mg 400 mg

5

LD50 681 mg/kg

tablets

tablets

oral rat

(211 kg)

Lactose

2

monohydrates

Maize starch

3

Magnesium

7

stearate

Erythromycin

115,000

Erythromycin

500 mg 1000 mg

7

LD50 >10.0 g/kg

500 mg tablets

tablets

stearate

oral mouse

(120.75 kg)

3

Maize starch

PVP-K-30

2

Primogel

6

Stearic acid

7

Magnesium

7

hydroxide

Glyceryl behenate

7

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Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility

Toxicity Level LD50

Dextromethorp

700,000

Dextromethorphan

2

LD5o 350 mg/kg

han tablets

tablets

HBr

oral rat

(84 kg)

Maize starch

3

Lactose

2

monohydrates

Magnesium

7

stearate

Famotidine 40 mg

600,000

Famotidine

40 mg

80 mg/

6

LD50 4049 mg/kg

tablets

tablets

tablet

oral rat

(123 kg)

Avicel

7

Starch 1500

5

PVP-K-25

2

Glyceryl behenate

7

Iron oxide

Carbamazepine

250,000

Carbamazepine

200 mg

200 mg

5

LD50 1957 mg/kg

tablets 200 mg

tablets

oral rat

(65 kg)

Avicel PH-101

7

Aerosil 200

7

Magnesium

7

stearate

CMC sodium

3

Primogel

6

Antiflu tablets

1,000,000

Paracetamol

200 mg

4000 mg

3

LD50 2404 mg/kg

tablets

oral rat

(620 kg)

Salicylamide

250 mg

4.5 mg

LD50 1700 mg/kg

oral rat

Phenylephrine

5 mg

LD50 350 mg/kg

oral rat

Promethazine HCl

5 mg

LD50 255 mg/kg

oral rat

Maize starch

3

PVP-K-30

2

Magnesium

7

stearate

Aerosil 200

7

Folic acid 5 mg

6,000,000

Folic acid

5 mg

5 mg/

7

LD50 >8000 mg/

tablets

tablets

day

kg oral rat

(690 kg)

Lactose

2

monohydrates

Maize starch

3

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Your Company's Name

Maximum

Therapeutic

Usage per

Product

Batch Size

Ingredients

Dose

Day

Solubility

Toxicity Level LD^

Avicel PH-102

7

Stearic acid

7

Aerosil 200

7

Gliclazide 80 mg

500,000

Gliclazide coarse

80 mg

160 mg

7

LD50 3000 mg/ kg

tablets

tablets (80 kg)

Lactose monohydrates Maize starch PVP-K-30 Magnesium stearate Avicel PH-102 Primogel

6

oral rat

Prednisolone

750,000

Prednisolone

20 mg

200 mg

6

LD50 1680 mg/kg

20 mg tablets

tablets (187.5 kg)

Magnesium stearate Lactose Avicel

2 7

oral mouse

Promethasone

600,000

Promethasone

25 mg

50 mg

1

LD50 255 mg/kg

25 mg F/C

tablets (20 kg)

Lactose monohydrates Maize starch PVP-K-30 Magnesium stearate Sodium disulfate

3 2 7

oral rat

Indapamide

1,000,000

Indapamide

2.5 mg

2.5 mg

7

LD50 >3000 mg/kg

2.5 mg F/C

tablets

oral rat

tablets

(95 kg)

Lactose monohydrates PVP-K-30 Maize starch Magnesium stearate Sodium lauryl sulfate

3 7

Diphenoxylate

1,000, 000 tablets

Diphenoxylate HCl

2.5 mg

30 mg

4

LD50 600 mg/kg oral rat

Atropine tabs

Atropine sulfate Lactose monohydrates

0.025 mg

0.3 mg

2

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Your Company's Name

Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility Toxicity Level LD5

Levofloxacin F/C 160,000

tablets

Paracetamol caplet 500

tablets (105.6 kg)

1,000,000 tablets (640 kg)

Aspirin 81 mg E/C tablets

2,000,000 tablets (230 kg)

Aspirin 300 mg 2,000,000 e/c tablets tablets

Attapulgite tablets 120,000 tablets (120 kg)

Lamotrigine 100 mg tablets

150,000 tablets (45 kg)

Maize starch Magnesium stearate Levofloxacin

Avicel PH-102 PVP-K-30 Hypromellose Paracetamol

Maize starch PVP-K-30 Magnesium stearate Gelatin Glycerol Primogel Aerosil 200 Aspirin Avicel PH-102

Magnesium stearate Aspirin

Avicel PH-102 Magnesium stearate

81 mg

300 mg

4 g/day

Attapulgite regular 19 kg

Attapulgite colloidal Klucel Sucrose Magnesium stearate PVP-K-30 Lamotrigine

11 kg

100 mg 200 mg

500 mg 1000 mg

500 mg 2000 mg

LD50 35,900 mg/kg oral rat; LD50 3366 mg/kg oral mouse

LD50 2404 mg/kg oral rat

LD50 200 mg/kg oral rat

LD50 200 mg/kg oral rat

750 mg 1500 mg Nontoxic

880 mg

LD50 185 mg/kg oral rat; LD50 269 mg/kg oral mouse

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Your Company's Name

Product

Batch Size

Ingredients

Maximum Therapeutic Usage per

Dose Day Solubility

Toxicity Level LD5

Sennosides 12 mg S/C tablets

Bisacodyl 5 mg tablets

Benzafibrate 200 mg tablets

Lomefloxacin 400 mg tablets

1,300,000 tablets (178.75 kg)

650,000 tablets (48.75 kg)

3,000,000 tablets (111 kg)

150,000 tablets (102.6 kg)

Avicel PH-102 Lactose monohydrates Primogel PVP-K-30 Iron oxide yellow Sennosides

Avicel PH-102 Magnesium stearate Lactose dried Starch 1500 Aerosil 200 Bisacodyl

Lactose Avicel

Maize starch Magnesium stearate Benzafibrate

Maize starch Magnesium stearate Methocel Avicel Primogel Lactose monohydrates Lomefloxacin HCl

Lactose monohydrates CMC calcium Klucel EF

Magnesium stearate Avicel PH-102

12 mg

72 mg/ day

5 mg

20 mg

200 mg 600 mg

400 mg 400 mg

LD50 4320 mg/kg oral rat

LD50 1082.0 mg/kg oral rat

LD50 1556 mg/kg oral rat

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Your Company's Name

Maximum

Therapeutic

Usage per

Product

Batch Size

Ingredients

Dose

Day

Solubility

Toxicity Level LD50

Acyclovir 800 mg

90,000

Acyclovir

800 mg

2400 mg

3

LD50 >20.0 g/kg

tablets

tablets (97.65 kg)

Avicel PH-102 Primogel Maize starch Magnesium stearate

7 6 3 7

oral rat

Loratadine 10 mg

1,000,000

Loratadine

10 mg

10 mg

7

Nontoxic

(115 kg)

Lactose monohydrates Maize starch Magnesium stearate

3 7

Mebendazole

150,000

Mebendazole

100 mg

100 mg

7

LD50 714 mg/kg

100 mg tablets

tablets (43. 05 kg)

Maize starch Avicel PH-102 PVP-K-30

3 7 2

oral rat

Methyldopa

285,000

Methyldopa

4

250 mg F/C

tablets

anhydrous

tablets

(101.175)

Guar gum Avicel PH-102 Aerosil 200 Ethyl cellulose Magnesium stearate

7 7 7

Glibenclamide

500,000

Glibenclamide

2.5 mg

20 mg/

6

LD50 >20,000 mg/kg

tablets

tablets (80 kg)

Lactose monohydrates Maize starch Magnesium stearate Aerosil 200 Talc fine powder

day

7 7

oral rat

Multivitamin M

1,300,000

Thiamine

2 mg

6 mg/

2

LD50 >1000 mg/kg

tablets

tablets

day

oral rat

(240 kg)

Riboflavin

1 mg

3 mg/ day

2

LDjo >20,000 mg/kg oral rat

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Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility

Toxicity Level LD50

Nicotinamide

15 mg

45 mg/

2

LD50 3500 mg/kg

day

oral rat

Vitamin D3

S00 IU

900 IU/

7

LD50 >2000 mg/kg

day

oral rat

Vitamin A

S000 IU

9000 IU/

7

LD50 7910 mg/kg

palmitate

day

oral rat

PVP-K-30

2

Avicel PH-102

7

Magnesium

7

stearate

Lactose

2

monohydrates

Magnesium oxide

7

Zinc sulfate

7

Bromhexine 8 mg

2,000,000

Bromhexine HCl

S mg

48 mg

6

LD50 1226 mg/kg

tablets

tablets

oral mouse

(240 kg)

Lactose

2

monohydrates

Maize starch

S

Gelatin powder

7

Magnesium

7

stearate

Ambroxol 30 mg

350,000

Ambroxol HCl

S0 mg

60 mg

4

LD50 13,400.0 mg/

tablets

tablets

kg oral rat

(84 kg)

Lactose

2

monohydrates

Maize starch

S

Aerosil 200/

7-7

AC-DI-Sol

Magnesium

7

stearate

Orphenadrine

1,000,000

Paracetamol

450 mg

3600 mg

S

LD50 2404 mg/kg

tablets

tablets

oral rat

(660 kg)

Orphenadrine

S5 mg

4

LD50 150 mg/kg

citrate

oral mouse

Maize starch

S

PVP-K-30

2

Primogel

6

Glycerol

5

Enalapril 20 mg

200,000

Enalapril maleate

20 mg

20 mg

S

LD50 2973 mg/kg

tablets

tablets

oral rat

(40 kg)

Lactose

2

monohydrates

Your Company's Logo

Your Company's Name

Product

Batch Size

Ingredients

Therapeutic Dose

Maximum Usage per Day

Solubility

Toxicity Level LD50

Magnesium

7

stearate

Maize starch

3

Starch 1500

5

Metronidazole

625,000

Metronidazole

500 mg

2000 mg

4

LD50 3000 mg/kg

500 mg tablets

tablets

oral rat

(593.75 kg)

Lactose

2

monohydrates

Avicel PH-102

7

Maize starch

3

PVP-K-30

2

Magnesium

7

stearate

Primogel

6

Mebendazole

400,000

Mebendazole

100 mg

200 mg

7

LD50 714 mg/kg

100 mg tablets

tablets

oral rat; LD50

(116 kg)

620mg/kg

oral mouse

Avicel PH-102

7

PVP-K-30

2

Primogel

6

Magnesium

7

stearate

Sodium saccharin

2

Sodium lauryl

2

sulfate

Ibuprofen 600 mg

650,000

Ibuprofen

600 mg

2400 mg

7

LD50 636 mg/kg

tablets

tablets

oral rat

(562.25 kg)

Maize starch

3

Magnesium

7

stearate

Starch 1500

5

Aerosil 200

7

Stearic acid

7

Metoclopramide

1,000,000

Metoclopramide

10 mg

30 mg/

1

LD50 280 mg/kg

10 mg tablets

tablets

day

oral mouse

(125 kg)

Lactose

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