Before Manufacturing any product in the Pharmaceuticals industry, we have to ensure that Line Clearance in Pharma product manufacturing is working well.
1. Destination:
1.1. To establish a line cleaning procedure before each stage of manufacturing products.
2. Scope:
2.1. This procedure applies to all stages of a product from expenditure of raw materials to the final packaging of products produced in bio-mark pharmacy.
3. Responsibilities:
3.1. Supervisor section
3.2. QA Manager.
3.3. QA Officer.
4. Procedure:
4.1. QA accepts “verbal intimacy for line clearance” from the raw material store for expenditure of raw materials, making it in BMR and removing raw materials according to SOP.
4.2. QA accepts “verbal intimacy for line cleaning” from the production department before starting each process of each product from batch manufacturing to the final packaging.
4.3. The QA document officer in cleaning the line which is part of BMR.
4.4. In 10-15 minutes receiving a request to the QA will check the area for cleaning which lines requested, convincing general cleanliness, checking temperature and humidity and ensuring that batch documents are available with complete information until each process.
4.5. Line Clearance in Pharma e will be removed after checking the area / line according to the procedure mentioned below:
4.6. GENERAL:
4.6.1. Check whether there should be no leftover from the previous product where
The process will begin.
4.6.2. Ensure that AHU is running and differential pressure is maintained in the area
(which one applies).
4.6.3. Check floors, walls, windows, containers, uniforms and ceilings to right
cleaning.
4.6.4. Check the temperature and relative humidity.
4.6.5. Check the product name, batch no., MFG. Date, exp. Date with Cross reference.
4.7. ORAL SOLID DOSING FORM (OSD): (Tablet / Capsule)
4.7.1. Make sure RO Water / Rinse water release / mixing tank report from QC
Department, before publishing lines cleaning for batch manufacturing.
4.7.2. Ensure the right temperature / is needed for drying trays,
4.7.3. Before Starting dry granulation and Final mixing pharmacist has to confirm that the batch has been completely dried
4.7.4. Publish clearance rows before attracting samples for tablets
Compression / capsule charging, and start operating immediately after QC
The department released samples on mass mixing and starting compression / capsules
Fill; and fill in the weight control sheet as attached to BMR.
4.7.5. Make sure the tablet release / report from the QC department after the coating, before
starting from the blistering stage; also do blister leak test before the start
Scuff.
4.8. SIRUP / LIQUID SUSPENCE:
4.8.1. Make sure RO Water / Rinse water release / mixing tank report from QC
Department, before publishing lines cleaning for batch manufacturing.
4.8.2. Make sure the release / reports of bulk mixing before attracting samples for
Fill in syrup / suspension.
4.8.3. Publish clearance rows before taking samples for syrup / charging suspension, and
Start the operation as soon as the sample was released by the QC department; also
The contents of the volume control sheet as attached in BMR for process volume control.
4.9. Printing & Packing:
4.9.1. Make sure batch No. Mfg date, date and price expiration for overprinting units
Carton / Scuff / Label etc., sign the sample specimen followed by the signature
from the production department.
4.9.2. Sign line line, as attached in the BMR wrote the previous product
with batch numbers and all other information written on line permission
Certificate Allow to start a line / process.
5.1 Line Clearance in Pharma Control Measure
Ensure the presence of line clearance certificate during the whole process If not present stop the line Generate NCR against respective department and ask for the line clearance request Assure the proper labeling on containers, shippers, trays and any other material that containing any type of raw or packaging material Ask the section supervisor to remove the all remnant of previous product.