Standard Operating Procedure of In-process Checks During the Manufacturing of Oral Solution in Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. To establish a procedure for the In-process checks during the manufacturing of all products.
2. Scope:
2.1. It is applicable to all the products being manufactured or Packed at Bio-Mark Pharmaceuticals
3. Responsibilities:
3.1. QA Manager
3.2. QC Officer
3.3. Production Pharmacist
3.4. Q.A Officer
4. Procedure:
4.1. Issuance of Raw Material & Packaging Components
4.1.1. Check the product name, strength, printing quality and quantity of Packaging components as assigned on B.P.O.
4.1.2. Weigh accurately the Raw Materials and attach identification slips with each material as per B.M.O.
4.1.3. Weighing Activity should be performed under the supervision of three persons i.e. one from warehouse, one from production & one from Q.A.
In-process Checks for Oral Solution:
4.2. Bottle Blowing:
4.2.1. Check the working of AIR HANDLING UNIT for positive pressure
4.2.2. Check the Trays and Nozzles for chocking.
4.3. Compounding and Solution Preparation:
4.3.1. Check the area for positive pressure, mopping and wearing of
uniform.
4.3.2. Check the cleaning of silicon pipes, filter assembly.
4.3.3. Get the QC approval for rinsed water of compounding vessel, water for
solution to be manufactured.
4.3.4. Check the proper assembling of pre-filter and final membrane filter
4.3.5. Get the QC approval for Filtration & transfer of solution to be filled.
4.4. Filling:
4.4.1. Switch on LFU, at least 45 minutes before filling.
4.4.2. Switch on A.C. at least one hour, before filling to achieve required
temperature & R. Humidity.
4.4.3. Check the preparation of fresh disinfectant and mopping solution and wearing
of uniforms.
4.4.4. Check the Temperature, R. Humidity, positive pressure of aseptic areas before
start of filling & monitor during filling operation.
4.4.5. Ensure aseptic assembling of machine parts and filling of oral solution.
4.4.6. Periodic checking of volume and sealing of Bottles
4.5. Coding of Packing Components:
4.5.1. Check the Stamps for B. No., Mfg & Expiry dates and price.
4.5.2. Check all the Stamps by stamping on B.P.O.
4.5.3. Use indelible pad ink for permanent print.
4.5.4. Ensure the removal of previous product packaging components.
4.5.5. Ensure the coding of cartons for product, Batch Nos. (If and when required)
4.6. Labeling:
4.6.1. Check the labels for product, potency, printing text and coding of B. No., Mfg and Expiry dates.
4.6.2. Clean the outer side of vials and check the proper adhering of labels on Bottles
4.7. Packing:
Remove all the packaging components of previous product / batch as per Line Clearance.
4.7.1. Check all the packaging components for product, B. No., potency and coding as per B.P.O.
4.7.2. Check the Bottles for product, B. No., Mfg, Expiry as per B.P.O. before packing.
4.7.3. Sequence of packing components should be according to specified procedure.
4.7.4. Fill the line inspection sheet and carry out periodic checks during packing.
4.7.5. After completion of Batch, submit the B.P.O. along with all in process documents to QC for Batch history record.
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