sop for sampling of bulk and finished product

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4 years ago

sop for sampling of bulk and finished product

1.0 OBJECTIVE
1.1 To describe a procedure for sampling of bulk and finished product.
2.0 SCOPE
2.1 This procedure is applicable to sampling procedure for bulk and finished product by Quality Assurance
3.0 RESPONSIBILITY
3.1 TRS shall raise by production Officer/Executive.
3.2 Sampling shall performed by IPQA Officer/Executive.
3.3 Head Production, Head QA and Head Quality Control shall ensure the compliance of the SOP.
4.0 ACCOUNTABILITY
4.1 Department Head
4.2 Head QA

5.0 PROCEDURE
5.1 Definitions
5.1.1 Blend: The homogenous mixture of powder/granules ready for next process of Manufacturing/packing (filling).
5.1.2 Bulk Product: Any product that has completed all processing stages up to, but not including final packing.
5.1.3 Finished Product: A product that has undergone all stages of production including packaging in its final container and labeling.
5.2 Sampling of Blend:
5.2.1 After receiving the TRS (Test Request Slip) from production to IPQA officer/executive as per Format No. IPQA officer/executive shall withdraw the required quantity of bulk sample for analysis as per sampling plan as described in format. Sample shall collect into poly bags having zip lock. (Note for light sensitive products, bulk samples shall collect into black polybags/amber colour container)
5.2.2 After withdrawal of bulk sample and same shall label as per Format ‘Sample For Analysis’ Format No. The sample withdrawal details (sampling quantity, date, sampled by) shall recorded in the TRS and the BMR of the respective product batch.
5.2.3 IPQA officer/executive shall send the labeled sample for analysis along with TRS to quality control department.
5.2.4 After receiving the sample for analysis quality control shall analyze the bulk sample as per approved In- process specification of the respective product.
5.2.5 Any out of specification occur during analysis shall handle as per SOP ‘Handling of Out of Specification’, SOP No.
5.2.6 Quality control officer/executive shall fill the test results in TRS and signed and same shall send the analysis results along with the filled TRS to IPQA department.
5.2.7 IPQA officer/executive shall review the analysis reports. The filled TRS shall attach to the BMR of the respective product batch.
5.2.8 Quality control officer/executive shall affix the Approved/Rejected label to containers containing bulk sample of the respective product batch.
5.3 Sampling of Bulk Tablets:
5.3.1 At the start of the compression production officer shall give TRS to IPQA officer/executive as per Format No.
5.3.2 After receiving the TRS from production to IPQA, IPQA Officer/Executive shall withdraw the required quantity of bulk sample (tablets) for analysis from both the side (LHS & RHS) at the start of the batch, at the end of the batch and throughout the entire compression process as per approved sampling plan. The samples shall collect into the poly bags having zip lock. (Note for light sensitive products, bulk samples (tablets) shall collect into black poly bags having zip lock.)
5.3.3 After withdrawal of bulk sample, it shall label as per format ‘Sample For Analysis’ The sample withdrawal details (sampling quantity, date, sampled by) shall recorded in the TRS and the BMR of the respective product batch.
5.3.4 IPQA Officer/Executive shall send the labeled sample for analysis along with TRS to Quality Control Department.
5.3.5 After receiving the sample for analysis QC shall analyze the bulk sample as per approved specification of the respective product. Any out of specification shall handle as per SOP ‘Handling of Out of Specification’, SOP No.
5.3.6 Quality Control Officer/Executive shall fill the test results in TRS and signed the same & shall send the analysis results along with the filled TRS to IPQA.
5.3.7 IPQA Officer/Executive shall review the analysis reports and filled TRS and shall attach the same to the BMR of the respective product batch.
5.3.8 Quality Control Officer/Executive shall affix the Approved/Rejected label to containers containing bulk sample of the respective product batch.
5.4 Bulk Sample of Liquids:

5.4.1 After receiving the TRS (Test Request Slip) from production to IPQA as per Format No.: IPQA officer/executive shall withdraw the required quantity of bulk sample into the plastic bottle from outlet of manufacturing tank as per sampling plan.
Note: Light sensitive bulk samples shall collect into amber coloured bottle bottles only. After withdrawal of sample into the bottle the bottle shall stoppered immediately.
5.4.2 IPQA Officer/Executive shall label the bottle containing sample as per format ‘Sample For Analysis’ Format No.: The sample withdrawal details (sampling quantity, date, sampled by) shall recorded in the TRS and the BMR of the respective product batch.
5.4.3 IPQA Officer/Executive shall send the labeled sample for analysis along with TRS to quality control department.
5.4.4 After receiving the sample for analysis quality control shall analyze the bulk sample as per approved In process specification of the respective product. Any out of specification occur during analysis shall handle as per SOP ‘Handling of Out of Specification’, SOP No.:
5.4.5 Quality control Officer/Executive shall fill the test results in TRS and signed the same and shall send the analysis results along with the filled TRS to IPQA department.
5.4.6 IPQA Officer/Executive shall review the analysis reports and same shall attach to the BMR of the respective product batch.
5.4.7 Quality control Officer/Executive shall affix the Approved/Rejected label to containers containing bulk sample of the respective product batch.
5.5 Sampling of Finished Goods:
5.5.1 After receiving the TRS (Test Request Slip) from production to IPQA as per Format No.: IPQA Officer/Executive shall withdraw the required quantity of finished goods sample at the start, middle and end of the packaging activity throughout the entire packaging operation of the respective product batch.
5.5.2 After withdrawal of finished good sample, it shall be labeled as per Format ‘Sample for Analysis’ Format No.: The sample withdrawal details (sampling quantity, date, sampled by) shall recorded in the TRS and the batch record of the respective product batch.
5.5.3 IPQA Officer/Executive shall send the labeled sample for analysis along with TRS to quality control department.
5.5.4 After receiving the sample for analysis quality control shall analyze the finished good sample as per approved finished product specification of the respective product. Any out of specification occur during analysis shall handle as per SOP ‘Handling of Out of Specification’, SOP No.:
5.5.5 Quality control officer/executive shall fill the test results in TRS and signed the same and shall send the analysis results along with the filled TRS to IPQA department.
5.5.6 IPQA officer/executive shall review the analysis reports and same shall attach to the batch record of the respective product batch.
5.6 Process Validation Sampling:
5.6.1 Process Validation sampling should be done as per the Validation Protocol (Sampling plan) of the respective product.
6.0 TRAINING
6.1 Trainer – Head-QA.
6.2 Trainee – All Concern Person.
6.3 Period – One hour or as per required.
7.0 DISTRIBUTION
7.1 One set of master copy & controlled copy submitted the quality assurance department.
8.0 ENCLOSURE
Test Request Slip
Sample For Analysis Label
Sample Withdrawal Register

Sampling Plan for Bulk Product
Sampling Plan for Finished Product

9.0 ABBREVIATIONS
9.1 SOP : Standard Operating Procedure
9.2 QA : Quality Assurance
9.3 QC : Quality Control
9.4 IPQA : In-process Quality Assurance
9.5 BMR : Batch Manufacturing Record
9.6 TRS : Test Request Slip
9.7 OOS : Out of Specification
10.0 DOCUMENT CHANGE HISTORY

Revision	Reason for Revision	Effective Date
00	NEW SOP