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Cleaning Validation MACO Swab Rinse Ovais

Cleaning Validation MACO Swab Rinse Ovais

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Published by Ovais08
The spreadsheet can be used for the calculation of FDA ICH Cleaning Validation acceptance criteria (MACO) for swab and rinse samples.
The spreadsheet can be used for the calculation of FDA ICH Cleaning Validation acceptance criteria (MACO) for swab and rinse samples.

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Published by: Ovais08 on Jan 21, 2009
Copyright:Traditional Copyright: All rights reserved

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08/15/2013

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quipment Name:Example
Add Company Name/Logo Here
Location: Tabletting BlockCompiled By:Ovais
ORAL PRODUCTSDate
2/7/2007Sampling Method
Swab SamplingParameterDescription ValueUnitsProduct A
Product selected for cleaning validation study (worst ca Product No. 5
AI
Active ingredient in Product AMefenamic AcidProduct with largest MDD (Maximum Daily Dose) valueProduct No. 1Product with smallest batch sizeCiprofloxacin HcL Tablet
CA
Active principle present in the cleaning agentlkylBenzene Sulphonate
I
Smallest strength of Product A manufactured500.000mg/day
 J
16.000Units/day
240000.000UnitsLethal Dose 50 for active ingredient in Product A740.000mg/kgLethal Dose 50 for the detergent240.000mg/kg
W
Average human body weight70.000kg
L
5000.000cm²
N
15.000kg
U
Swab area25.000cm²/Swab
SF
Safety Factor ¹ (for "Dose criterion" only)0.001
RF
Risk Assessment Factor (for "Toxicological criterion" onl0.001¹ Give justification for using safety factor other than 0.001 in the CV Protocol
Summary: MACO for both AI & CA to subsequently manufactured productCriterionMACOActive IngredientCleaning AgentDose
37.500 mg/25 cm²
Toxicological
1.943 mg/25 cm²
0.630 mg/25 cm²
10 ppm
0.750 mg/25 cm²
0.750 mg/25 cm²
Visual Limit
1.000 mg/25 cm²1.200 mg/25 cm²
Determination of Acceptance Criteria forCleaning Validation (CV) Studies
Product B
1
Product B
2
Maximum number of dosage units of Product B
1
taken/dNumber of dosage units per batch of final mixture of Pr
LD
50
-AILD
50
-Detergent
Equipment surface area in common between Product ABatch size of Product B
2
INSTRUCTIONS:
Fill in the
Coral
input fields as mentioned (read thecomments if needed)
 
INSTRUCTIONS:
Fill in the
Coral
input fields as mentioned (read thecomments if needed)
Dose Tox.10 ppmVisual0.05.010.015.020.025.030.035.040.0ActiveCleaningAgent
Limit(mg/25cm²)
 
 
reron
 
Formulae used for calculation:A) Dose criterion
((SF x I)/J) x (K/L) x U
WhereI = Smallest strength of product A manufactured/day expressed as mg/day & based on the number of mg of active ingredient
B) Toxicological Criterion
(NOEL x RF) x K x U J x L
WhereNOEL = No observed Effect Level =E = Empirical Constant = 2000
C) 10 ppm Criterion
R x (N/L) x U
Where
All the abbreviations used in the formulae are defined in the table above (see Description)References:
Pharm. Technol. 17(4), 54-60 (1993).Institute of Validation Technology, 1997.(CEFIC, Brussels, December 2000), available at http://apic.cefic.org/pub/pub-cleaning-validation.pdf, accessed Feb 5, 2009.
mg
of active ingredient in product A permitted per 25 sq cm swab area =
mg
of active ingredient in product A permitted per 25 sq cm swab area =
NOEL = LD
50
X (W/E)
LD
50
= Lethal Dose 50 in mg/kg animal for active ingredient in product ARF = Risk Assessment Factor = 0.01 - 0.001 (
for Oral Products
)
mg
of active ingredient in product A permitted per 25 sq cm swab area =R = 10 mg active ingredient in product A/kg Product B
2
N = Number of kgs per batch of final mixture of Product B
2
1. Fourman, G.L. and Mullen, M.V., "
Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Op
2. W.E. Hall, “
Validation of Cleaning Processes for Bulk Pharmaceutical Chemical Processes
”, Cleaning Validation - An Exclusive3. CEFIC - Active Pharmaceutical Ingredients Committee (APIC),
Guidance on aspects of cleaning validation in active pharmaceuti
This spreadsheet may not be resold or distributed. Please requestauthor (mohammad@xepasp.com for any changes required to bemade).
 
This spreadsheet may not be resold or distributed. Please requestauthor (mohammad@xepasp.comfor any changes required to bemade).
 
Note
:(
NOEL
x
RF
) =
ADI
(Acceptable DailyIntake)

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Manoj Mishra added this note
very use full, if u give more suitable example if multi product facility (product runing in campaign basis) then how it is calculated...... Example: we have runing 4 product in one facility then how we calculate the limit of residue ?
WiwiRahayuHasan liked this
Ilham Ilhamiitaa liked this
very usefull
Fazy Masthan added this note
thanks alot ovais for this wonderul stuff!!!
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