SOP Title: Manual Inspection of Tablets and Capsules
- Objective:
To define procedure for Manual Inspection of Tablets and Capsules.
- Scope:
This SOP is applicable to manual inspection of tablets and capsules in production department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedure as mentioned in the SOP.
- Quality Assurance Department: To give line clearance. To review and approve the SOP.
- Engineering Department: To perform the Maintenance of the area and providing utility for performing activity.
- 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.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
- Remove the previous batch residue.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases
- Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in product/Change in Colour.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part or change in colour.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v).
- Procedure
- Definition:
| Precautions: | ||
| 5.2.1 | Ensure that the line clearance is taken before start of inspection. | |
| 5.2.2 | Scoops, Containers and Trays used for inspection should be clean. | |
| 5.2.3 | During inspection, use nose mask and hand gloves. | |
| 5.2.4 | Ensure that the container used for product storage should be clean and dry. | |
| 5.2.5 | Ensure that the temperature and relative humidity are within the limit as per product requirement. | |
| 5.3 | Procedure: | |
| 5.3.1 | Before starting inspection, check the product container label for Product Name, Batch No., Net weight, status of the product etc. | |
| 5.3.2 | After check from production officer, start the inspection of tablets / capsules. | |
| 5.3.3 | Tablets with defective features like capping, chipping, broken, foreign particles (black particles), other colour spots, laminated, sticking and picking tablets etc. should be removed from the final product. | |
| 5.3.4 | Defected capsules like double cap, powder on capsule, black or colour spots, printing defects etc should be removed from the final product. | |
| 5.3.5 | Keep the defected tablets / capsules in separate poly bag with duly labelled as “REJECTS”. | |
| 5.3.6 | The rejected Tablets / Capsule should be weighed and recorded in Batch Manufacturing Record. | |
| 5.3.7 | Good sorted tablets / capsules should be weighed and recorded in BMR and transfer to the bulk finished area with proper label. | |
| 5.3.8 | Rejected tablets / capsules should be disposed off after authorisation from department head and QA. | |
| 5.3.9 | After completion of activity label the accessories as “To Be Type A Cleaned” or “To Be Type B Cleaned” as per SOP. | |
| 5.4 | Type A Cleaning (Batch to Batch Cleaning) | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.4.2 | Remove all previous batch documents, containers and labels from the area. | |
| 5.4.3 | Clean the trays, Scoops and other accessories with the help of clean dry duster. | |
| 5.4.4 | Visually ensure the cleanliness and affix “Type A CLEANED” label as per SOP. | |
| 5.5 | TYPE B Cleaning (Product to Product Cleaning) | |
| 5.5.1 | Remove in process status label and affix “To be Type B cleaned” status label. | |
| 5.5.2 | Remove all labels, containers and documents of previous product. | |
| 5.5.3 | Keep the trays/accessories on trolley and transfer to the wash area for cleaning by covering with poly bag with “To Be Type B Cleaned” label. | |
| 5.5.4 | Cleaning of Trays/ Accessories: Clean the trays/accessories first with potable water to remove the adhered powder then apply 0.1 % soap (teepol) solution then wash with sufficient quantity of potable water. Finally rinse with purified water. | |
| 5.5.5 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the Swab / Rinse samples of the trays. Refer Annexure. | |
| 5.5.6 | Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.4. | |
| 5.5.7 | Drying of trays: Wipe all Trays/Accessories with a clean dry lint free duster then put the trays in tray cabinet in reverse position. |
- Abbreviation:
| Abbreviation | Expansion |
| PDD | Production Department |
| No. | Number |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| ml | Mili Litre |
| v/v | Volume by volume |
*Note – Ready to use SOP available in “DOWNLOAD” Section.