SOP on Cleaning of Sampling Aids


1.0 Objective

To lay down a procedure for Cleaning of Sampling Aids.

2.0 Scope

This standard operating procedure is applicable for cleaning of sampling aids after sampling of drug products and different raw materials at pharmaceutical formulation plant.

3.0 Responsibility

3.1 Trained Worker shall be responsible for cleaning of Sampling Aids.

3.2 Production and Quality personnel shall be responsible for checking and verification of sampling aids cleanliness after cleaning and before sampling respectively.

 4.0 Accountability

4.1 Head – Production, Head – Quality shall be accountable for implementation of this SOP.

5.0 Abbreviations and Definitions

SOP                             :            Standard Operating Procedure

Sampling Aid              :           All the devices used for the sampling purpose i.e. Spatulas, Spoons                                                                     and Sampling Rod etc.

6.0 Procedure

6.1 After sampling, wrap the sampling device with butter paper / polyethylene sheet along with “TO BE CLEANED” label and transfer to washing area.

6.2 Clean the total surface of sampling devices with running potable water.

6.3 Finally rinse with purified water.

6.4 Allow to drain the water from the sampling device and wipe with clean wet (with 70% IPA) lint free cloth. Wipe the sampling device with Clean, dry Lint free cloth.

6.5 Check visually for the cleaning of the device and re-clean if required / found dirty.

6.6 After sampling of each batch above cleaning procedure for sampling aids shall be followed.

6.7 The cleaned sampling device shall be used within seven days. If not, re-cleaning shall be done.

6.8 After cleaning ‘Cleaned Label’ shall be affixed.

7.0 Forms and Records (Annexures)

Not Applicable

8.0 Distribution

Master copy      –      Quality Assurance

Controlled copies –      Quality Assurance, Production, Quality Control, Stores

9.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP