by - Objective
To lay down the procedure for rinse water analysis. Rinse water analysis is being done to avoid chances of cross contamination from one product to another. By this method we assure that the machine / equipment is free from active ingredients of previous product..
- Scope
This SOP is applicable in quality control for rinse water analysis.
- Responsibility
QC Chemist / Officer : To follow the procedure and maintain as applicable.
- Accountability
Head Quality Control : For System Compliance
- Procedure:
- After cleaning of machine / equipment Production Chemist fill the details in rinse water intimation / analysis report and give to QA Chemist after signing.
- QA chemist should examine the rinse water visually for foreign particles and for any odour in case of Oral Liquids.
- If rinse water contains foreign particles or any odour for flavour like menthol then ask for rewashing as per specified procedure.
- After physical examination QA chemist should collect approx. 200 ml rinse sample and send it to Q.C. for analysis.
- QC chemist shall enter the details of rinse water sample in Rinse Water Inward Register.
- QC chemist should identify the traces of active ingredients in the rinse sample by scanning the sample between 200-400nm and note the absorbance of remarkable peak. Check the pH of sample (between 5.0 to 7.0).
- If the sample shows negative identification or no remarkable peak in the scan then rinse sample passes the test.
- Fill the analysis report and handover to QA after signature of Head QC/designee.
- IPQA inform to Manufacturing Chemist for the same and enter the details in the BPR.
- Annexure (S)
NA
- Reference (S)
In-house
- Glossary
SOP : Standard Operating Procedure
HOD : Head of Department
QC : Quality Control
QA : Quality Assurance
- Revision History
| Rev. No. | Details of changes | Reason for change |
