SOP For Sampling of Swab/Rinse

1.  OBJECTIVE:

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for sampling of Rinse / Swab during manufacturing of different products.

• SCOPE:

This SOP is applicable for sampling of Rinse / Swab during manufacturing of different types of products at manufacturing facility.

• RESPONSIBILITY:
  • Authorized designee of QA shall prepare the SOP & receive the requisition and collect the sample.
  • Head QA shall approve the SOP and ensure its proper implementation to avoid contamination during manufacturing of products.

•    PROCEDURE:
  • During manufacturing all rinse and swab sample should be withdrawn by IPQA person.
  • For sampling of rinse and swab production persons shall prepare the swab/rinse intimation slip (F/QA042/01) and submit to IPQA officer/designee for sampling.
  • IPQA Person shall collect sampling kit & collect the sample according to specified location.
  • Rinse sampling: After satisfactory visual inspection, rinse sampling is carried out by using purified water. Rinse sample allow sampling of a large surface area and of inaccessible system or ones that cannot be routinely disassembled. 100 ml rinse sample should be collected from each identified sampling point for analysis.
  • Swab Sample: Swab sampling should be collected from pre-determined location swab sample should be collected by using nylon swab in 10 ml of purified water for analysis. wipe the swab sampling surface (25.8064 cm²) continuous  in Zig-Zag condition  as show in diagram given below.

• OfficerIPQA shall collect the sample from the specified sampling location, Swab sampling should be collected from pre-determined location swab sample should be collected by using nylon swab in 10 ml of purified water for analysis. Wipe the swab sampling surface (25.8064 cm²) continuous in Zig-Zag condition the diagram given below.
  • Officer IPQA shall collect swab / rinse sample and submit to quality control / Microbiology department for analysis. 
  • Officer QC shall receive the slip and analysis the sample and submit the report to IPQA.
  • If cleaning sample (Rinse/Swab) fails during QC analysis, investigation (OOS) shall be carried out to find the root cause.
  • If in the investigation it has found the cleaning sample (Rinse/Swab) has been failed due to improper cleaning, the equipment shall again re-clean and sample shall be send to QC.
  • The equipment shall be release only after the effective evaluation of the re-cleaning.
•    TRAINING:

                        Trainer                                     :  Head – Quality Assurance

                        Trainees                                   :  Departmental / Sectional Heads of production,

                                                               Packaging, QC, Microbiology, stores.

•    DISTRIBUTION:

         Controlled Copy No.1            :  Head of Department – Quality Assurance

         Controlled Copy No.2            :  Head of Department – Production

         Controlled Copy No.3            :  Head of Department – Quality Control

         Controlled Copy No.4            :  Head of Department – Microbiology

         Controlled Copy No.5            :  Head of Department – Warehouse / Stores

         Controlled Copy No.6            :  Head of Department – Packing  

Original Copy                      :  Head – Quality Assurance

• ANNEXURE:

            Annexure-I                              :  Rinse and Swab Analysis Intimation

• REFERENCES:

Nil

• REVISION HISTORY:

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	———–	New SOP	New SOP