Procedure for Sampling of Rinse water Swab

1.0 Objective
To lay down a procedure for sampling of rinse water/ swab.
2.0 Scope
This Standard Operating Procedure is applicable for sampling of rinse water in production

to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive Production shall give intimation to QA for collection of rinse water / swab sample.
3.2 Officer / Executive QA shall be responsible for sampling of rinse water / swab sample for analysis.
3.3 Officer / Executive Production shall send the sample to QC for analysis.
3.4 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
A.R.No. : Analytical Report Number
No. : Number
5.0 Procedure
5.1 Rinse water sampling
5.1.1 Rinse water sampling shall be performed after cleaning the equipment for every

product to product changeover i.e. after Type ‘B’ cleaning and after five consecutive batches of the same product.
5.1.2 Officer/Executive QA shall receive intimation from Officer/Executive production

for sampling of rinse water of equipment used in production department.
5.1.3 Take required quantity of purified water for particular equipment. Pour into cleaned

equipment (contact part of equipment).
5.1.4 Collect rinse water (approximate 50 ml) from equipments in clean, dry glass

bottle / pet and label the bottle, duly filled and signed (Annexure-1).
5.1.5 Submit the sample to QC department for rinse water analysis (Annexure-2).
5.1.6 QC shall perform analysis of the sample, prepare the analysis report and same shall be sent to QA department.
5.1.7 After receiving rinse water analysis report, production department shall

affix ‘CLEANED’ label on the equipments duly filled and signed.
5.1.8 If sample does not comply, QC department shall immediately intimate to

Head QA / his designee for further action.
5.2 Swab water sampling
5.2.1 Swab water sampling shall be performed after cleaning the equipments and

area for every product to product changeover.
5.2.2 Officer/Executive QA shall receive intimation from production for sampling

of swab water of equipments / areas in production department.
5.2.3 Officer/Executive QA shall take required quantity of sterile swab sticks for particular parts of equipment / area.
5.2.4 Collect the swab sample from clean surface of particular parts of

equipment / area surface (approximate-100 sq.cm) 10×10 sq.cm 10 sq.cm in vertical position

and 10 sq.cm in horizontal position and label the swab sample duly signed.
5.2.5 Submit the sample to QC department for swab analysis (Annexure-2).
5.2.6 From point 5.1.6 to 5.1.8 shall be followed for swab sample also.
5.2.7 Annexure -2 is the duplicate logbook one copy is attached in

BPCR and second copy is initiator department.
6.0 Forms and Records
6.1 Rinse Water / Swab Sample Label – Annexure-1
6.2 Rinse Water/Swab Intimation Cum Report – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance, Quality Control and Production.
8.0 History