Validation Document

Document No.:

Validation Protocol
Cleaning Validation for Product Name
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COMPANY NAME
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Company Name
LOGO
Address
CLEANING VALIDATION FOR PRODUCT NAME
Protocol No. Effective Date
Supersedes No. Page No. 2 of 13

INDEX

Sr. No. Content Page No.

1.0 Validation Protocol Approval 3

2.0 Objective 4

3.0 Scope 4

4.0 Pre-Requisites 4

5.0 Product Composition 4

6.0 Details of Product & Validation Study Plan 5

7.0 Responsibilities 5

8.0 Equipments & Equipment Areas 5

9.0 Activity Flow Chart 6

10.0 Cleaning Procedures 6

11.0 Sampling 6

12.0 Validation Team 9

13.0 Analytical Method 10

14.0 Acceptance Criteria and MACO Calculation 10

15.0 Data Compilation and Evaluation 12

16.0 Deviations 12

17.0 Incident/ Failures 12

18.0 Documentation 12

19.0 Revalidation Criteria 12

20.0 Post Approval 13

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Company Name
LOGO
Address
CLEANING VALIDATION FOR PRODUCT NAME
Protocol No. Effective Date
Supersedes No. Page No. 6 of 13

9.0 ACTIVITY FLOW CHART

Identification of Preparation of Cleaning

Processing Procedures
Equipments Wash Water
Quantity
Determination of Preparation & Approval
Equipment Area of Cleaning Validation
Protocol Mode of Cleaning

Sampling Plan
Product Manufacturing
Identification of
Hard to Clean
Sampling Areas
Methods Equipment Cleaning &
Sampling

Redefine
Test Method for
Residue Testing & Data
Estimation Compilation

Acceptance
Criteria Cleaning Reports for
Individual Runs

Cleaning Validation Results are Outside the

Report Acceptance Criteria

10.0 CLEANING PROCEDURES

a) After completion of manufacturing and packing activity for Product Name, cleaning shall be done
as per the standard cleaning procedure for that particular equipment.
b) Initial cleaning of equipment shall be done by potable water.
c) Validated detergent shall be used for cleaning of the equipment.
d) Temperature of water for cleaning purpose shall be 25 ±2°C.
e) Final cleaning of equipment shall be performed with purified water.

11.0 SAMPLING
11.1 Sampling Method: Swab sampling
11.2 Type of Swabs Used:
Polypropylene Swab manufactured by Manufacturer Name (Product code)
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Company Name
LOGO
Address
CLEANING VALIDATION FOR PRODUCT NAME
Protocol No. Effective Date
Supersedes No. Page No. 11 of 13

 Conversion factor
Next Product considered is Next Product Name.
a) Lowest Daily Dose of active or the lowest manufacturing strength of Previous Product is:
_________mg
b) The product which shall be considered as Next Product: Product Name.
c) Minimum Batch size of the Next Product: ___________ kg
d) Maximum daily therapeutic dose of Next Product: ____________ mg
e) Average weight of Next Product is: ____________ mg
f) Maximum daily dose of unit of Next Product _________ mg is
Maximum daily dose of active (mg) x Unit average (mg)
Active weight in unit (mg)
= _________mg

MACO Calculation:
MACO = LDD x Minimum Batch size of next product (Kg) x SF (0.001) x CF (106)
Maximum daily dose of next product (mg)
LDD = Lowest Daily Dose of active or lowest manufacturing strength of previous product (mg)
MACO = Maximum allowable carryover of active from previous batch in next product/ batch
SF = The Safety Factor for the tablet or capsule dosage form that shall be considered as
1/1000 or 0.001
CF = Conversion factor (from Kg to mg)

MACO = _____________________________________ mg

14.5 Calculation of Residue Limit/ Swab: The residue limit allowed per swab shall be calculated
based on Maximum Allowable Carryover (MACO) as follows
Residue Limit /Swab (µg) = MACO (mg) x Swab Area (cm2) X CF (1000)
Equipment Area (cm2)
= _______µg
Dilution of Swab is to be done in _______ ml of solvent.
Hence, the limit for the residue/ swab in ppm
Residue /Swab (ppm) = Residue Limit/ swab (µg)
Swab desorbing amount (ml)
= __________ µg/ ml or ppm