Procedure for measurement of fill weight during batch filling
- To lay down the procedure for measurement of fill weight during batch filling.
- This SOP is applicable for measurement of fill weight during batch filling in Injectable department.
- Operators/Technician – Responsible for measurement of fill weight during batch filling.
- Executive /Officers production – Responsible for implementation of the SOP.
- HOD – Production shall be accountable for the compliance of the SOP.
- Operating Personnel shall ensure that weighing balance used for fill weight checking has been calibrated as per the respective SOP.
- Production officer/ Executive shall update the status board with fill weight mentioned in respective batch BMR.
- Operating personnel shall adjust the fill weight as per details mentioned on status board.
- Operating personnel shall collect the fill weight samples after adjusting the fill weight.
- Operating personnel shall press the following icon on the filling machine PLC to perform the sampling for fill weight checking.
- The samples for the fill weight check as per the respective dosing will pass through the two sample collecting/rejection collecting belts which are parallel to outlet belts through the deviators.
- Operating personnel shall collect the samples from the sample collecting/rejection collecting belts which are parallel to outlet belts of the filling machine.
- Operating personnel shall mark and collect the sampled vials with serial number (starting from 1) based on the type of dosing done in respective batch in an SS tray.
NOTE: The operating personnel shall collect the sampled vials with help of Forceps.
- Operating personnel shall transfer the collected sampled vials to Weighing balance.
- Operating personnel shall ensure that the balance reading is zero before the start of the weighing activity.
- Operating personnel shall place a clean empty glass beaker on the weighing pan of the weighing balance.
- The operating personnel shall tare the weight of the glass beaker before the discharge of the API from the sampled vial.
- Operating personnel shall weigh the sampled vials as per the respective serial number as collected.
- The operating personnel shall print the weight of each and every individual vial after the completion of weighing.
- The operating personnel shall finally print the cumulative weight of the sampled vials as per the respective dosing.
- The operating personnel shall transfer the used vials and stoppers to the waste bin provided after the completion of weighing activity.
NOTE: The API collected during the fill weight checking shall be collected separately and shall be destroyed as per respective SOP after the completion of days filling activity.
- Production officer/Executive shall collect the print out of the sampled vials, record the weighing details and enclose the same to the respective batch BMR.
- The IPQA officer/Executive shall verify the details of the weighing from the attached weight print out and recorded details in the BMR.
- The production activity shall be continued if the fill weight measured from the sampled vials of the respective batch are with in the limits.
- The production activity shall not be continued if the fill weight measured from the sampled vials of the respective batch are not with in the limits.
- The fill weight shall be adjusted again and the sampled vials shall be weighed as per above procedure.
NOTE: In case of any fill weight adjustment failure the same shall be documented in the BMR.
- The operating personnel shall carry out the fill weight checks through out the days filling activity as per the frequency mentioned in BMR.
- List of Annexure:
- Not Applicable.
- References (if any):
- SOP on calibration of Analytical Balance.
- SOP on operation and change over of vial filling and bunging machine.
- SOP on Handling of rejects generated at all stages of batch processing.
- SOP : Standard Operating Procedure.
- IPQA : In Process Quality Assurance.
- HOD : Head of Department.
- BMR : Batch Manufacturing Record.
- PLC : Programmable logic control.
- API : Active Pharmaceutical Ingredient.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube