CLEANING VALIDATION (POLICY) PHILOSOPHY

CLEANINGCVMP
VALIDATION MASTER PLAN (CVMP) Kiran Kota

CLEANING VALIDATION LIFE CYCLE

PHASE-II PHASE-III
PHASE-I
CLEANING PROCESS VALIDATION CONTINUAL CLEANING PROCESS
CLEANING DESIGN
/QUALIFICATION VERIFICATION

Cleaning process Development (Verification) Cleaning Validation Plan Continual monitoring of Cleaning process

Quality Risk Management

Change Control

Understanding the Equipment Scientific rationale

Analytical Method / Technique
establishment
(Development) selection Cleaning Process Qualification
Equipment train identification Cleaning results trending annually

KIRAN KOTA
Establishment of worst case
Specific Non-Specific
Establishment of cleaning process repeatability
Identification of Equipment
Cosmetic changes * Product grouping basis

Mitigation controls Solubility basis

Analytical Method Verification Establishment of Cleaning Alerts limit establishment

Identification of Critical to Equipment basis Batch to batch cleaning /
reach Area Product to product cleaning /
Common / unknown cleaning Campaign cleaning /
Identification of Hard to clean process basis Periodical cleaning /
Area Exposed equipment cleaning
Cleanability basis Analytical Method Validation

Fixed / Disassembly parts Investigation for crossing of alert limits (If any)
Cleaning agent selection

Establishment of COQ / VRL /

Sampling method identification Recovery establishment (Plant
VVR & Angle of view
Critical sampling point with / Lab)
scientific rationale Establishment of Efficiency of cleaning process / Sampling
technique / Analytical Method / Cleaning Operator / Analyst
Exposed equipment
Rinse Swab on the whole equipment train / CEHT#/ DEHT#
identification
Re-visiting the cleaning process /technique / Method /
Cleaning Method Identification Practice / Limits
Clean in place / Clean out of
Sample solution stability /
place
Ancillary equipment & Utensils Sample solution storage
(Automatic / Semi-Automatic /
& Sampling aids covering condition establishment
Manual)

Report & Conclusion & Recommendations (If any)

Cleaning process establishment
Surface area calculation
Re-validation (If necessary)based on
including all the equipment
Feasibility & Verification
train & Ancillary equipment /
Utensils Analytical Residue limits
Optimizing the flow rate / establishment
CPPs/CSPs/Temperature/
CQA's/CEHT#/DEHT# Microbial Attributes Reestablishment of cleaning process if warranted based on
Any major change Introducing of new Change in cleaning
conclusion agent or
in the cleaning product which is
procedure found as worst case concentration of
cleaning agent
Training

* Absence of residue (Product / Impurity) shall be proven. Specifically Genotoxic impurities / NDSRI /AZIDO, Byproducts (if any), Insitu stages (if any) etc. # CEHT / DEHT establishment shall be done either in Phase-I or Phase-II based on feasibility or requirement