SOP Title: Line Clearance in Production Area
- Objective:
To lay down procedure for line clearance of the area/equipment.
- Scope:
This procedure is applicable to the following areas and equipments used for manufacturing of product/material and related activities.
- Dispensing area
- Granulation area
- Compression area
- Capsule filling area
- Coating area
- Primary/Secondary packing area
- Carton Coding area
- Responsibility:
Concerned Department: To carry out all the preliminary checks as per this procedure/and or as per product/material requirement.
QA Department: To counter check/verify all the equipments and area for suitability of use as
per procedure.
- Accountability:
Head QA/All Department Heads
- Procedure:
- Definitions:
- QA Associate: Officer/Executive or any personnel of Quality Assurance Department trained to perform duties as per this SOP.
- Concerned Department: Department in which the respective area/equipment/instrument is installed, operated and responsibility of cleaning lies with.
- Concerned Department Associate: Officer/Executive or any personnel of Concerned Department trained to perform duties as per this SOP.
- Procedure:
| 5.2.1 | The equipment and area shall be cleaned as per respective SOP and type of cleaning (Type A or B) required, immediately after batch manufactured/processed or product activity carried out in the equipment/area. | |
| 5.2.2 | After cleaning intimation shall be given to QA personnel to collect rinse/swab sample (not required in case of type A cleaning) from the cleaned equipment. | |
| 5.2.3 | QA personnel shall verify the equipment and area visually for cleanliness, take rinse/swab sample (as applicable) and send to the QC Department for testing. | |
| 5.2.4 | After performing initial checks as mentioned below for equipment/line and area, Concerned Department personnel shall request QA personnel to line clearance. | |
| 5.2.5 | On request from Concerned Department personnel for line clearance, the QA personnel shall check all the points/line where the risk of contamination, cross contamination or mix-up exists. | |
| 5.2.6 | General procedure:
For line clearance following checks shall be performed : |
|
| 5.2.6.1 | The House keeping general cleanliness of the area. |
|
| 5.2.6.2 | Ensure the equipment and utensils are clean, verify it visually. | |
| 5.2.6.3 | Ensure the absence of any other materials, labels etc of the previous products in the area. | |
| 5.2.6.4 | Check the temperature & relative humidity of the area. | |
| 5.2.6.5 | Check the differential pressure of the area. | |
| 5.2.6.6 | Check the functioning and cleaning of return raiser. | |
| 5.2.6.7 | Ensure the status label on the equipment/ packing line. | |
| 5.2.6.8 | Check the presence of related Batch Manufacturing Record / Batch Packing Record issued by QA Department. | |
| 5.2.6.9 | Release status of issued materials/ product bulk batch. | |
| 5.2.6.10 | Check the correctness of the product and Packing Materials of the product undertaken with respect to the identification and strength. | |
| 5.2.6.11 | Check the log books for up dated entry of last activity. | |
| 5.2.6.12 | Check the filled line clearance label for the correct product details. | |
| 5.2.6.13 | Check the calibration status of instruments of related equipment. | |
| 5.2.6.14 | Ensure that all the equipment in the area are well assembled and operating properly. | |
| 5.2.6.15 | Ensure that Cleaning of the area/equipment (Type A and Type B)
is not exceeding its validity period as per production SOP. |
|
| 5.2.6.16 | Ensure that the software setting parameter entered in the HMI/MMI
or Control Panel for the previous batch/product is deleted and clear for next batch setting. |
|
| 5.2.6.17 | Check rinse/swab report for cleaning compliance as applicable. | |
| 5.2.6.18 | Check the correctness of the product/Packing Materials of the product undertaken with respect to the identification and strength. | |
| 5.2.6.19 | Check the conveyor belt and surrounding area clean and free from any previous product and any material. | |
| 5.2.7 | Specific check points to be performed during line clearance | |
| 5.2.7.1 | Specific checks shall also be performed during line clearance of equipment and area. | |
| 5.2.7.2 | Follow BMR/BPR instructions for product and process requirement before line clearance. | |
| 5.2.8 | If the all requirements are fulfilled, then Concerned and QA Department personnel shall sign on the line clearance label as well as sign in the defined place given in respective BMR/BPR and release the area/equipment for processing/activity. | |
| 5.2.9 | In case of any failure to comply the line clearance, it shall be considered as incident and incident shall be reported and filed. | |
| 5.2.10 | After taking corrective action, QA personnel shall ensure line clearance again and then only batch record shall be signed. |
- Abbreviation:
| Abbreviation | Expansion |
| BMR | Batch Manufacturing Records |
| BPR | Batch Packing Records |
| SOP | Standard Operating Procedure |
| HMI | Human Machine Interface |
| MMI | Man Machine Interface |
*Note – Ready to use SOP available in “DOWNLOAD” Section.