SOP Title: Sampling of In-process and Finished Products
- Objective:
To lay down procedure for sampling of in-process and Finished Products in routine manufacturing practice.
- Scope:
This procedure is applicable to all products manufactured at the site.
- Responsibility:
Production Department: To intimate QA person for sampling at defined stage of manufacturing and follow the procedure.
QC Department: To receive, log and analyse the sample as per specified procedure and prepare test report.
QA Department: To sample the in-process and Finished Products per instructions at defined stages of manufacturing.
- Accountability:
Head QA Department.
- Procedure:
5.1 Definitions:
Inprocess material: In-process material means any material fabricated, manufactured or blended that is produced for, and used in, the preparation of the finished product.
Finished product: A finished dosage form, for example a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally but not necessarily, in association with inactive ingredients in a final marketed pack.
QA Associate: Officer/Executive or any personnel of Quality Assurance Department trained to perform duties as per this SOP.
Production Associate: Officer/Executive or any personnel of Production Department trained to perform duties as per this SOP.
QA Associate: Officer/Executive or any personnel of Quality Control Department trained to perform duties as per this SOP.
5.2 Procedure:
| 5.2.1 | Sampling at the Granulation stage | |
| 5.2.1.1 | Generally sampling of the blend (and as per instruction given in BMR/SPC/STP) shall be done at granulation stage. | |
| 5.2.1.2 | After completion of the blending process, Production person shall refer the sampling instruction in BMR and intimate QA person for sampling of the blend (lubricated granules) by filling Intimation Slip. | |
| 5.2.1.3 | QA person shall refer the BMR instruction and verify the record and Intimation Slip. | |
| 5.2.1.4 | It shall be ensured that cleaned sampling tools (spatula, thief or rod etc), clean sampling bags are available for sampling of blend. | |
| 5.2.1.5 | It shall be ensured that lubricated blend has been completely unloaded from the blender into cleaned double polythene lined HDPE drums. All the containers shall be inspected physically before sampling. | |
| 5.2.1.6 | Generally a composite 10 gram sample (and/or as per instruction given in BMR/SPC/STP) shall be taken from all containers of unloaded granules (blend) by using appropriate tool. | |
| 5.2.1.7 | The sample along with Intimation Slip shall be sent to the QC Department for analysis. | |
| 5.2.1.8 | The blend shall be kept properly in the Quarantine till test report come. | |
| 5.2.2 | Sampling at the compression stage | |
| 5.2.2.1 | After completion of the compression process, Production person shall refer the sampling instruction in BMR and intimate QA person for sampling of the compressed tablets by filling Intimation Slip. | |
| 5.2.2.2 | QA person shall refer the BMR instruction and verify the record and Intimation Slip. | |
| 5.2.2.3 | It shall be ensured that the batch has been completely compressed and the tablets are kept in cleaned double polythene lined HDPE drums. All the containers shall be inspected physically before sampling. | |
| 5.2.2.4 | QA person shall take sample from the container which contains tablets representing whole batch taken by the operator/chemist at every half an hour interval for weight variation checks within the compression cubicle. | |
| 5.2.2.5 | QA person shall mix the tablets manually then take the tablets quantity 60 tablets (and/or as per instruction given in BMR/SPC/STP) and enclose in the sample poly bag. | |
| 5.2.2.6 | The sample along with Intimation Slip shall be sent to the QC Department for analysis. | |
| 5.2.2.7 | The compressed tablets shall be kept properly in Quarantine till test report come. | |
| 5.2.3 | Sampling at the coating stage | |
| 5.2.3.1 | After completion of the coating process, Production person shall refer the sampling instruction in BMR and intimate QA person for sampling of the coated tablet by filling Intimation Slip. | |
| 5.2.3.2 | QA person shall refer the BMR instruction and verify the record and Intimation Slip. | |
| 5.2.3.3 | It shall be ensured that the coating process is completed and the coated tablets are kept in cleaned double polythene lined HDPE drums. All the containers shall be inspected physically before sampling. | |
| 5.2.3.4 | QA person shall take composite 60 tablets (and/or as per instruction given in BMR/SPC/STP) sample into clean sample poly bag from each drum and label the sample poly bag. | |
| 5.2.3.5 | The sample along with Intimation Slip shall be sent to the QC Department for analysis. | |
| 5.2.3.6 | The coated tablets shall be kept properly in the Quarantine till test report come. | |
| 5.2.4 | Sampling at capsule filling stage | |
| 5.2.4.1 | After completion of the capsule filling process, Production person shall refer the sampling instruction in BMR and intimate QA person for sampling of the filled capsule by filling Intimation Slip. | |
| 5.2.4.2 | QA person shall refer the BMR instruction and verify the record and Intimation Slip. | |
| 5.2.4.3 | It shall be ensured that the capsule filling process is completed and the filled capsules are kept in cleaned double polythene lined HDPE drums. All the containers shall be inspected physically before sampling. | |
| 5.2.4.4 | QA person shall take composite 60 capsules (and/or as per instruction given in BMR/SPC/STP) sample into clean sample poly bag from each drum and label the sample poly bag. | |
| 5.2.4.5 | The sample along with Intimation Slip shall be sent to the QC Department for analysis. | |
| 5.2.4.6 | The filled capsule shall be kept properly in the Quarantine till test report come. | |
| 5.2.5 | Sampling of finished products | |
| 5.2.5.1 | After completion of the packing operations, Production person shall refer the sampling instruction in BPR and intimate QA person for sampling of the finished product by filling Intimation Slip. | |
| 5.2.5.2 | QA person shall refer the BPR instruction and verify the record and Intimation Slip. | |
| 5.2.5.3 | It shall be ensured that the packing operation is completed and BPR is filled properly. | |
| 5.2.5.4 | QA person shall take sample from the container which contains strips/blisters representing whole batch taken by the chemist at one hour interval in the packing line. | |
| 5.2.5.5 | QA person shall take a composite of 60 tablets/capsules (and/or as per instruction given in BMR/SPC/STP) as such packed in the strip/blister for chemical analysis. | |
| 5.2.5.6 | For retention/control sample, at least twice of complete analysis sample shall be taken from three time point sampling stage (initial, middle and end) of packing operation and the sample shall be taken as such in the carton. | |
| 5.2.5.7 | The Finished Product sample along with Intimation Slip shall be sent to the QC Department for analysis. | |
| 5.2.5.8 | The Finished Product shall be kept properly in Quarantine till test report come. | |
| 5.2.6 | Labelling of samples | |
| 5.2.6.1 | The sample shall be labelled properly at least with the contents like Product Name, Batch No., Batch Size, Mfg. Date, Exp. Date, Stage, and Sample Quantity. | |
| 5.2.6.2 | Label shall be duly verified by QA person with respect to correct information clearly written on it. | |
| 5.2.6.3 | The sample shall be enclosed properly to avoid any chances of contamination and mix up. | |
| 5.2.6.4 | Samples shall be sent to the QC Department without any delay and logged in specified register. |
- Abbreviation:
| SOP | Standard Operating Procedure |
| BMR | Batch Manufacturing Record |
| BPR | Batch Packing Record |
| SPC | Specification |
| STP | Standard Test Procedure |
| HDPE | High Density Polyethylene |
*Note – Ready to use SOP available in “DOWNLOAD” Section.