SOP Title: In-Process Quality Control of Tablets/Capsules
- Objective:
To define procedure for in-process checks during production activity.
- Scope:
This SOP is applicable to in-process quality control checks for tablets and capsules during production activity to assure that the product manufactured is within standard specifications.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedure for in-process checks described in the SOP .
- Quality Assurance Department: To ensure the products meets the specification. To review and approve the SOP.
- Engineering Department: To perform the Preventive Maintenance and Calibration of the instruments.
- Accountability:
Head, Production Department. Head, Q.A. Department.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or operator of engineering department trained to perform duties as per this SOP.
- Procedure
- Definition:
| Precautions: | ||
| 5.2.1 | Ensure that In-Process Quality Control instruments are cleaned and calibrated before use. | |
| 5.2.2 | Ensure that the line clearance has been taken prior to starting the batch. | |
| 5.2.3 | Check that, all the machines and containers should be labelled with the batch identification label. | |
| 5.2.5 | Use hand gloves while handling the product. | |
| 5.2.6 | In-process friability checked tablets should not be added in the tablet container. It should be destroyed by putting in water for hazardous waste disposal Bin. | |
| 5.3 | In-process checks for Tablets:. | |
| 5.3.1 | Check that the temperature and relative humidity (25oc ± 2oc and 55% ± 5%RH) are within the limit at all stages of manufacturing and packing. | |
| 5.3.2 | Record the temperature and humidity in individual in-process control sheet of the BMR. | |
| 5.3.3 | During granulation, in process tests such as LOD should be checked and recorded as mentioned in respective product BMR | |
| 5.3.4 | Check all the tablets for appearance, embossing (if applicable) and should be free from any physical defects. | |
| 5.3.5 | Set the compression parameters as mentioned in BMR and collect two rounds of tablets from each discharge chute. | |
| 5.3.6 | Label the tablet container dully filled with product name, batch number, current stage, next stage, LHS and RHS (if applicable). | |
| 5.3.7 | In process test samples tested should be counted during reconciliation. | |
| 5.3.7 | Weigh individual tablets container one by one from LHS as well as RHS and note down the observations in the product BMR. | |
| 5.3.8 | In-process sample quantity should be collected as mentioned in individual product BMR. | |
| 5.3.9 | At the start of compression and thereafter, following in-process tablet parameters should be checked.
|
| Sr. No. | In-process Test details | Limits | Frequency |
| 1 | Diameter of tablets | As limit mentioned in BMR | Initially at start of the batch. |
| 2 | Group weight of 20 tablets | As limit mentioned in BMR | Every half an hour. |
| 3 | Friability | NMT 1 % w/w or as mentioned in product BMR | As mentioned in BMR. |
| 4 | Thickness | As limit mentioned in BMR | As mentioned in BMR. |
| 5 | Hardness | As limit mentioned in BMR | As mentioned in BMR |
| 6 | Uniformity / individual weight variation | As limit mentioned in BMR | As mentioned in BMR |
| 7 | Disintegration time | As limit mentioned in BMR | As mentioned in BMR |
5.3.10 If the tablets are coated, following in-process parameters have to be checked for coated tablets during coating process as mentioned in BMR.
| Sr. No. | In-process Test details | Limits | Frequency |
| 1 | Inspection of coated tablets for all lots of batch.
|
Coating should be uniform, smooth, colour uniformity for whole batch. |
As per BMR |
| 2 | Group weight of 20 tablets. | As mentioned in product BMR. | As per BMR |
| 3 | Thickness of tablets. | As mentioned in product BMR. | As per BMR |
| 4 |
Hardness of tablets. |
As mentioned in product BMR. | As per BMR |
| 5 | Disintegration time. | As mentioned in product BMR. | As per BMR |
| 5.3.5.3.11
|
During blister / strip or Bulk packing, in-process checks to be done for cartons, labels and blisters for batch number, date of manufacturing, date of expiry, maximum retail price (if any), other markings and leak test to be performed
for blister / strips as mentioned in product BMR. |
|
| 5.3.12 | During blister / strip or Bulk packing, in-process checks to be done for cartons, labels and blisters for batch number, date of manufacturing, date of expiry, maximum retail price (if any), other markings and leak test to be performed
for blister / strips as mentioned in product BMR. |
|
| 5.3.13 | Check the over printing matter by referring product specifications or respective product BPR initially and thereafter as frequency mentioned in BPR. | |
| 5.3.14 | Record the online in process test result in batch packing record. | |
| 5.3.15 | Collect the number of sample for leak test as mentioned in product BPR. | |
| 5.3.16 | The entire sample should pass the leak test as per leak test apparatus SOP. | |
| 5.3.17 | Routinely check the container by visually to ensure that leaflet, silica bag are properly enclosed in containers as per requirement.
Ensure the sealing of containers is properly done in case of bulk packing. |
|
| 5.3.18 | Ensure the shrink packing is done properly and check number of cartons or containers in shrink pack whenever applicable. | |
| 5.3.19 | During bulk packing, check the quantity of tablets packed in the container using manual counter and also check for defective tablets, over printing details of container labels and shipper labels. | |
| 5.3.20 | During blistering, check the quantity of strips pack in the carton and also check for defective tablets, over printing details of carton and shipper label. | |
| 5.3.20 | Check the shipper packing and check the pack size of the shipper i.e. number of carton or containers inside the shipper. | |
| 5.3.21 | Note: If any in-process test fails or difficult to judge the result, then test should be repeated by taking another sample. | |
| 5.4 | In-process checks for Capsules: | |
| 5.4.1 | Before start of production activities. | |
| 5.4.2 | Continuously collect 20 Capsules in SS bowl / poly bag and label accordingly indicating the product name and Batch No. | |
| 5.4.3 | Check and record group weight of 20 Capsules as mentioned in the BMR. | |
| 5.4.4 | Similarly, weigh the individual weight of 20 Capsules one by one and note observations in the BMR or as mentioned in product BMR. | |
| 5.4.5 | Check the lock length, disintegration test, appearance as per frequency mentioned in respective product BMR. | |
| 5.4.6 | If required, adjust the machine parameters to comply the test and it should be within specified limit as per BMR. |
- Abbreviation:
| Abbreviation | Expansion |
| BMR | Batch Manufacturing Record |
| BPR | Batch Packing Record |
| SOP | Standard Operating Procedure |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| QA | Quality Assurance |
| LOD | Loss on Drying |
| oC | Degree Centigrade |
| % | Percent |
| w/w | Weight by weight |
*Note – Ready to use SOP available in “DOWNLOAD” Section.