Ab

(BFS, Liquid & Semi-Solid Unit)

Dhaka, Bangladesh

EQUIPMENT HOLD TIME VALIDATION PROTOCOL FOR ORAL LIQUID

Doc. No.: EHTS-P/BLS-QA/001 Revision No.: 01 Effective Date: Page No.: 11 of 17

APPENDIX-A
DESCRIPTION OF EQUIPMENT
 DEHT /  CEHT

Equipment Name: ____________________________________Serial/ ID No. : ______________________

Location & Room No : _________________________________Surface Area (cm2):_________________

Product Name: _________________________________________ Batch No: _______________________

Manufacturing Date: _____________________________________Batch Size:______________________

Active Ingredient: _______________________________________________________________________

Acceptance Criteria for Line (mg):_____________ Total Surface Area for Line (cm2): _______________

Rinse Volume (ml): ______________________________________________________________________

Acceptable Active Residue in This Equipment Surface Area: ___________________________________

Hold Starting Date: ___________________________ Hold Starting Time: ______________________

Hold end Date: _______________________________ Hold end Time: __________________________

Cleaning Date: _______________________________ Cleaning Time:___________________________

Cleaning SOP No.: ____________________________ Cleaning Logbook No.:____________________

Sampling Date : ______________________________ Sampling Time:___________________________

Analytical Method No: ___________________________________________________________________

Sampling Locations: ____________________________________________________________________

Remarks:

Prepared By :______________________ Checked By:_______________________