Selection Criteria for type of Cleaning in Production area

In this post Standard Operating Procedure of Selection Criteria for type of Cleaning in Production area in Pharmaceuticals is describe. 

1.0   OBJECTIVE:

To lay down the procedure for Selection criteria for type of cleaning in production area.

2.0   SCOPE:

This procedure is applicable for Selection criteria for type of cleaning in production area.

3.0   RESPONSIBILITY:

Officer /Executive/Assistant Manager

Head Production: To ensure execution and compliance. Head QA: To ensure the compliance.

4.0   PROCEDURE:

4.1   TYPE A:

Change over from one batch to next batch of the same product and same potency and of similar 

product with ascending potency.

4.1.1   Replace the “TO BE CLEANED” status label with “UNDER CLEANING” status label with date and 

signature of Production Officer.

4.1.2   Ensure that the main power supply is put OFF.

4.1.3   Dry-clean the equipment with a dry lint free cloth as per respective equipment cleaning 

SOP.

4.1.4   Replace the “UNDER CLEANING” status label with “CLEANED” status label with date and 

signature of Production Officer.

4.2   TYPE B:

This is a cleaning procedure for Change over of product with different actives / colour / 

descending potency or after maintenance of contact parts.

4.2.1   Follow the procedure from step no. 4.1.1 to 4.1.2.

4.2.2   Intimate to Utility Department for collecting all the return air riser filters of 

respective area for cleaning, through filling the required details in the Intimation cum return air 

riser filter cleaning record as per Annexure-I. Dismantle and clean the equipment with purified 

water/sodium hydroxide / IPA / Sodium Lauryl Sulphate as per respective equipment cleaning SOP.

4.2.3   Replace the previous ‘CLEANED’ status label with current date ‘CLEANED’ status label with 

date and signature of Production Officer.

4.3   Swab Sample:

4.3.1   Swab sample shall be taken after type – B cleaning and every new product introduction in 

the facility. (Change over of product with different actives / colour / descending potency or after 

maintenance of contact parts.)

4.4   Frequency:

4.4.1   Type ‘A’ cleaning is applicable after completion of every batch of same product.

4.4.2   Type ‘B’ cleaning is applicable in case of product change over.

5.0   ANNEXURE (S):

ANNEXURE - I: Intimation cum Return air riser filter cleaning record.

6.0   REFERENCE (S):

SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating 

Procedure (SOP).

7.0 ABBREVIATION (S) /DEFINITION (S) :

QA : Quality Assurance

SOP : Standard Operating Procedure