To lay down a procedure for Cleaning of Sampling Aids.
This standard operating procedure is applicable for cleaning of sampling aids after sampling of drug products and different raw materials at pharmaceutical formulation plant.
3.1 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.
4.1 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.
6.1 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)
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control, Stores
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