Sop for Cleaning Validation

1.0 Purpose

The purpose of this document is to describe procedure for the validation of cleaning procedure of machine/area.

2.0 Scope

This document on cleaning validation is intended to address special consideration and issues pertaining to validation of cleaning procedure.

3.0. 3.0 Terms & Definitions

Terms	Definitions
Validation	Establishing documented evidence which provide high degree of confidence that a specific system will consistently produce a product meeting its predetermined specifications and quality.

4.0 Responsibilities

a. Plant Manager

i. To supervise and ensure the execution of the cleaning validation according to procedure and in accordance with the validation schedule.

ii. To approve the cleaning validation protocol and report.

b. Validation Manager

i. To manage the cleaning validation.

ii. To review the cleaning validation protocol and report

c. Quality Control Manager

i. To make arrangement for the analysis of cleaning validation.

d. Officer (Validation)

i. To prepare cleaning validation protocol.

ii. To perform cleaning validation according to procedure.

iii. To provide the sample for cleaning validation to quality control along with Technical InformationSheet.

iv. To prepare the cleaning validation Report.

5.0 Environment, Safety and Health Precautions

The environment, safety and health parameters that are implemented for sampling and during analysis are also applicable during cleaning validation activities.

a. During sampling masks and gloves should be used.

b. Samples must be identified.

c. Masks and gloves should be used during analysis.

d. Pipetting by mouth must be prohibited.

e. Dispose off the samples hygienically according to procedure for the disposal of wastes.

1.0 6.0 Procedure

To achieve these acceptable levels, cleaning procedures need to be established and validated, sampling and analysis will be carried out for this purpose to assure that the machine / equipment or area of interest complies with specified limits. Cleaning validation will also verify the effectiveness of cleaning procedure.

Following are the prerequisite of the cleaning validation.

a. Cleaning validation is intended to address special consideration and issues pertaining to validation of cleaning procedures for machine / equipment or area used in manufacturing of pharmaceutical & biological products.

b. It is also intended to establish inspection consistency and uniformity with respect to equipment cleaning procedures.

c. It is intended to cover validation of equipment cleaning for the removal of contaminates associated to the previous products, residues of cleaning agents as well as the control of potential microbial contaminate.

Cleaning validation is performed as mentioned in master validation plan (will be prepared) in coordination with relevant department head in accordance with cleaning validation protocol and results are recorded in cleaning validation report.

Cleaning Validation Protocol comprises into following requirements:

a. Abstracts

b. Unit Operation

c. Objective

d. Scope

e. Responsibilities

f. Sample Procedure

g. Analytical Method

h. Acceptance Criteria

i. Change Control

j. Observation/Deviation

k. Impact of Deviation

l. Corrective Action

m. Conclusion

Cleaning Validation Report comprises into following:

a. Cleaning Procedure

b. results

a. Cleaning Validation Method

After receiving intimation for cleaning of machine/equipment or area, witness the cleaning according to predetermined cleaning procedure.

During cleaning check and note down the following points.

i. Description of machine/equipment/area:

ii. Major Product contact components:

iii. Previous product/batch #:

iv. Detergent / Solvent used

v. Cleaned by:

vi. Supervised by:

After cleaning take sample either by direct surface sample (Swab Method) or rinse sample depending upon the nature of machine/equipment and product.

Send the sample to QCD along with technical information sheet for analysis.

QCD analyze the sample according to written procedure and submit the results to Validation Department.

Validation Department analyzes the results, if the results comply with the specified limit, then the machine/equipment or area is considered as cleaned and is allowed for further process.

If the results do not comply with the specified limit, then test until clean. This concept involves cleaning, smpling & testing until an acceptable residue limit is obtained.

Also record the following.

a. Sampling Method followed:

b. Analytical Method followed: ­­­­­­­­­­­

c. Any deviation has been encountered during Cleaning, Sampling & analysis.