The purpose of a Product Processes and Quality of In Process Material system is to provide staff and management with objective insight into the process and related work products. Your process and product quality approach supports the delivery of high-quality products by providing project staff and managers at all levels with appropriate visibility into the process and related work products throughout the life of the pharmaceuticals.

Product Processes and Quality of In Process Material

Objective:-

To ensure compliance of Product Processes and quality of in process material.

Responsibility:-

1. Section Supervisor
2. Production Manager
3. QA Incharge

Procedure:-

Issuance of Raw Material & Packaging Components

1. Check the product name, strength, printing quality and quantity of Packaging components as assigned on B.P.O.
2. Weigh accurately the Raw Materials and attach identification slips with each material as per B.M.O.
3. Weighing Activity should be performed under the supervision of three persons i.e. one from warehouse, one from production & one from Product Processes and Quality of In Process Material Q.A.

Washing

1. Check the working of AIR HANDLING UNIT for positive pressure
2. Check the washing of Trays and Nozzles for chocking.
3. Check the washing cycle of vials and ampoules as per specified procedure.
4. Check the washing of machine parts and their wrapping in Aluminum foil or butter paper.
5. Sterilization
6. Check the load pattern of sterilizers for proper Air circulation and Temperature uniformity.
7. Check the setting of Targets Temp and timer for sterilization cycles.
8. Check the closing of opposite door before opening the front door.
9. Ensure that both doors of sterilizer are not opened simultaneously.
10. Check the door closing and locking prior to start of sterilization

Compounding / Solution Preparation

1. Check the area for positive pressure, mopping and wearing of sterilized uniform.
2. Check the cleaning and sterilization of silicon pipes, filter assembly.
3. Get the QC approval for rinsed water of compounding vessel, water for injection or solution to be manufactured.
4. Check the proper assembling of pre-filter and final membrane filter 0.2 microns.
5. Get the QC approval for Filtration & transfer of solution to be filled.

Filling

Product Processes and Quality of In Process Material

1. Switch on LFU, at least 45 minutes before filling.
2. Switch on A.C. at least one hour, before filling to achieve required temperature & R. Humidity.
3. Check the preparation of fresh disinfectant and mopping solution and wearing of sterilized uniforms.
4. Check the Temperature, R. Humidity, positive pressure of aseptic areas before start of filling & monitor during filling operation.
5. Verify the sterilization of machine parts, vials, ampoules, rubber stopper, uniforms and holding vessels before start of filling.
6. Ensure aseptic assembling of machine parts and filling of powder, rubber stopper, vials and ampoules.
7. Ensure the pre and post flushing of ampoules with nitrogen during ampoules filling.
8. Periodic checking of weight / volume, nitrogen flushing and sealing of ampoules.

Terminal Sterilization

1. Ensure the terminal sterilization of filled ampoules at specific temperature and time as per specified procedure.

Leakage Test

1. Ensure the leakage test is performed at prescribed conditions as and when required.

Optical Checking

Product Processes and Quality of In Process Material

1. Ensure 100% optical checking of filled ampoule / vials for fibers, black particles, glass pieces and any other foreign matter.
2. Check the sealing quality and volume / weight of filled ampoules / vials.

Overprinting of Ampoules

1. Check for product, B. No. Mfg & Expiry dates, MLNO, Reg. No. and company name.
2. Check to ensure that over printing ink is indelible (permanent print)

Coding of Packaging Components

1. Check the Stamps for B. No., Mfg & Expiry dates and price.
2. Check all the Stamps by stamping on B.P.O.
3. Use indelible pad ink for permanent print.
4. Ensure the removal of previous product packaging components.
5. Ensure the coding of cartons for product and water for Injection, Batch Nos. (If and when required)

Labeling

1. Check the labels for product, potency, printing text and coding of B. No., Mfg and Expiry dates.
2. Clean the outer side of vials and check the proper adhering of labels on vials.

Packing

Remove all the packaging components of previous product / batch as per LINE CLEARANCE CERTIFICATE (F-08-018)

1. Check all the packaging components for product, B. No., potency and coding as per B.P.O.
2. Check the Ampoules for misprint and breakage before packing.
3. Check the Ampoules / Vials for product, B. No., Mfg, Expiry as per B.P.O. before packing.
4. Sequence of packing components should be according to specified procedure.
5. Fill the line inspection sheet and carry out periodic checks during packing.
6. After completion of Batch, submit the B.P.O. along with all in process documents to QC for Batch history record.

In-Process Tests of Tablets

DESCRIPTION

1. Take the sample and measure physically as per specification.
2. Frequency: Before Start of Production and after each 30 minutes.

DIAMETER

Measure the side length of the tablet by Vernier caliper ,put the tablet between the jaws of Vernier caliper and note the length of the tab according to the specification, Product Processes and Quality of In Process Material first check the zero setting if there is any loosen then turn the bezel to the set ,0 , point of dial to the pointer.

Frequency: Before Start of Production

THICKNESS

Measure the thickness of the tablet by Vernier caliper ,put the tablet between the jaws of Vernier caliper and note the thickness of the tab according to the specification, first check the zero setting if there is any loosen then turn the bezel to the set ,0 , point of dial to the pointer.

Frequency: Before Start of Production and after each 30 minutes

FRIABILITY TEST

1. Ensure that the instrument is clean and and free from dust
2. Weight accurately the tablets
3. Open the apparatus from one removable side of the drum
4. Transfer the tablet and close the drum tightly.
5. Switch “ON” the apparatus and count the resolutions as specified in the monogram.
6. Rotate the drum 100 times and remove the tablets
7. Remove any loose dust or broken tablets and weigh
8. Switch “OFF” the instrument when not required
9. Frequency: Before Start of Production

HARDNESS

1. Ensure that the instrument is clean and free from any residue of dust and tablet
2. Particle. Product Processes and Quality of In Process Material Hold the tab in the jaw and nozzle in edgewise position.
3. Adjust the scale, so that the zero on the scale coincides with the pointer
4. Turn the screw knob till the tablet breaks. the pressure indicated on the dial is in kilogram per sq.cm.

DISINTEGRATION

Perform the Disintegration test of the required product as mentioned in the individual monograph and calculate the results accordingly.

Frequency: At Start

DISSOLUTION

Perform the Dissolution test of the required product as mentioned in the individual monograph and calculate the results accordingly.

Frequency: At Start

BULK ASSAY

Perform the assay of bulk as per Standard analytical procedure of required product and calculate the result accordingly.

Frequency: At Completion of Bulk Mixing.

AVERAGE WEIGHT

Take 20 tablets and weight them, Product Processes and Quality of In Process Material then note the weight of a single tablet according to the specification

Frequency: At Start and after each 30 minutes

WEIGHT VARIATION

According to the specification the average weight of the tablets can vary 5 % above or below the average weight.

Frequency: At Start and after each 30 minutes Product Processes and Quality of In Process Material