SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules
OBJECTIVE :
To provide a procedure for representative sampling of In-process blends,
uncoated tablets, coated tablets and filled capsules.
RESPONSIBILITY :
Officer – Quality Assurance.
Head – Quality Assurance to ensure compliance.
PROCEDURE :
After receiving the “Inprocess Analysis Request and report / Inprocess analysis
request for commercial batches/Analysis Request “(Annexure -1a,1b,1c respectively)
from Production department, the concerned QA Officer shall fill the “Sample for testing ” labels (Annexure -2)
Before collecting the samples check that all the containers are labeled with “Product label” (Annexure -2).
During sampling, the concerned person shall put on Hand gloves and wear a mouth mask. Sample shall be collected with clean and dry stainless steel spoons/thieves in clean and dry suitable size HDPE/Glass containers with proper closures.
Inprocess blend samples of about 25 gms as pooled sample shall be collected from upper, middle and bottom layers from containers / bins using sampling thieves.
| Total No. of containers/bins | A sample quantity of the blend |
| 1 | about 25 g |
| 2 | Collect about 12.5g from each container/bin and mix |
| 3 or more | Collect about 10 g from each container/bin and pooled |
| the sample from that 25 g collection. |
Officer – QA shall follow the collection of the unit dose sampling for blend uniformity
as per SOP “Unit Dose sampling procedure for blend uniformity”.
For uncoated tablets, coated tablets, and filled capsules, samples shall be collected from all the containers in the following manner.
| Total No. of containers | A sample quantity of tablets/capsules |
| 1 | about 250 |
| 2 | Collect about 125 from each container and mix |
| 3 | Collect about 80 from each container and mix |
| 4 | Collect about 60 from each container and mix |
| 5 | Collect about 50 from each container and mix |
| 6 | Collect about 40 from each container and mix |
| 7 | Collect about 35 from each container and mix |
| 8 or more | Collect about 30 from each container and mix, from there take 250. |
Label the sample HDPE/Glass container with ‘Sample for testing’ (Annexure -2).
Affix the “Under Test” label on the product label.
After completion of sampling, the concerned QA Officer shall fill the “Inprocess Analysis Request and Report/Analysis Request” with all data and sign with date.
QA Officer shall send the samples alongwith the “Inprocess Analysis Request and Report/Inprocess analysis request for commercial batches/Analysis Request” to QC department.
The concerned QC Officer shall enter the details of the sample in the AR Register – Formulations (Annexure-3) and allot A.R No.
The concerned QC Officer shall enter the A.R. No. on the “Inprocess Analysis Request and Report/Inprocess analysis request for commercial batches/Analysis Request” and “Sample for Testing” label.
Forms and Records (Annexures)
Specimen format of “Inprocess Analysis Request and report / Inprocess analysis request for commercial batches/Analysis Request “- Annexure -1.
Specimen of labels ” Product Label”, “Sample for testing” and “Under test ” Annexure-2.
Specimen format of “AR Register – Formulations” – Annexure 3.
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
Annexure -1
Specimen format of “In process Analysis Request and report / In-process analysis request for commercial batches/Analysis Request “
- PILOT PRODUCTION/PRODUCTION
- Request No.:
- Date:
- Product :
- Batch Number :
- Batch Size :
- Mfg. Date :
- Stage :
- Average weight :
- Analysis Required :
- Sample Quantity
- PO(Sign./Date)
- QAO (Sign./Date)
- AR No. :
Annexure-2.
Specimen of labels ” Product Label”, “Sample for testing” and “Under test ”
- PRODUCT LABEL
- Product :
- Batch No. :
- Batch size. :
- Stage :
- Container No. :
- Gross weight :
- Tare weight :
- Signature :
- Net weight :
- Date :
- CHEMINOR
- SAMPLE FOR TESTING
- Product :
- Batch No.:
- ARNo. :
- Stage :
- Mfd. :
- Sampled by :
- Sampled on :
- CHEMINOR
- UNDER TEST
- Product :
- Batch No. :
- Stage :
- Batch Size :
- Mfd.:
- Exp. :
- Sampled on :
- Container No.:
- Signature :
- CHEMINOR
Annexure-3
Specimen format of “AR Register – Formulations”
- Name
- Stage
- Batch/Lot No.
- Date of Mfg.
- Date of expiry
- Batch size
- AR. No
- Sampled on
- Sample received on
- Approved/Rejected
