Cleaning of Dispensing and Sampling Tools
- To lay down a procedure for Cleaning of Dispensing and Sampling Tools after dispensing and sampling activities respectively.
- This standard operating procedure is applicable for Cleaning of Dispensing and Sampling Tools
- Trained Worker shall be responsible for cleaning of Dispensing/Sampling Aids.
- Store & QC personnel shall be responsible for checking of dispensing and sampling tools cleanliness as per SOP.
- Store In charge, Quality Control Head and Quality Assurance Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
- SOP : Standard Operating Procedure
- Sampling Tools : All the devices used for the sampling purpose i.e. Spatulas, Spoons and Sampling Rod etc.
- IPA : Iso Propyl Alcohol
- After dispensing or sampling activities, wrap the tools with butter paper / polyethylene sheet along with “TO BE CLEANED” label and transfer to washing area.
- Clean the total surface of tools with running potable water.
- Finally rinse with purified water.
- Allow to drain the water from the tools and wipe with clean wet (with 70% IPA) lint free cloth. Wipe the tools with clean, dry lint free cloth.
- Check visually for the cleaning of the device and re-clean if required / found dirty.
- After dispensing/sampling of each batch, the above mentioned cleaning procedure for dispensing and sampling tools shall be followed.
- The cleaned sampling device shall be wrapped with clean aluminum foil/butter paper/polythene.
- After cleaning ‘Cleaned Label’ shall be affixed.
- The cleaned sampling device shall be kept in respective areas.
- The cleaning details shall be recorded as per Annexure – I.
- The cleaned sampling device shall be used within five days. If not, re-cleaning shall be done.
Forms and Records (Annexures)
- Cleaning Record of Dispensing & Sampling Tools – Annexure I
- Master copy – Quality Assurance
- Controlled copies – Stores, Quality Control, Quality Assurance
Cleaning Record of Dispensing & Sampling Tools
|Prepared by||Checked by||Approved by|
|Deptt. Head||Head QA|
|Sign & Date|
|Effective Date: Next Review Date:|
|AREA: Dispensing Booth (ID No. ______________) / Sampling Booth (ID No. __________)|
|Date||Product Name||Batch No.||Dispensing / Sampling Tools||Done by||Checked by||Remarks|
Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field.
During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube