In-process Checks SOP



  In-process Checks SOP



1.0   PURPOSE:

1.1.         To establish a procedure for the In-process checks during the manufacturing of all products.

2.0    SCOPE:


2.1.         It is applicable to all the products being manufactured or Packed at ____ Pharmaceuticals.

3.0   RESPONSIBILITY:


3.1.      QA Manager
3.2.      QC Officer
3.3.      Production Pharmacist
3.4.      Q.A Officer


4.0    PROCEDURE:


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.
In-process Checks For Tablets:
4.8.      Diameter:
4.8.1.   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, 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 Compression
4.9.      Thickness:
4.9.1.   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
4.10.    Friability Test:
4.9.2.   Ensure that the instrument is clean and free from dust
4.9.3.   Weight accurately the tablets
4.9.4.   Open the apparatus from one removable side of the drum Transfer the tablet
    and close the drum tightly.
4.9.5.   Switch “ON” the apparatus and count the resolutions as specified in the
    monogram.
4.9.6.   Rotate the drum 100 times and remove the tablets
4.9.7.   Remove any loose dust or broken tablets and weigh
4.9.8.   Switch “OFF” the instrument when not required
            Frequency:      Before Start of Production
4.11.    Hardness:
4.11.1. Ensure that the instrument is clean and free from any residue of dust and tablet
4.11.2. Particle. Hold the tab in the jaw and nozzle in edgewise position.
4.11.3. Adjust the scale, so that the zero on the scale coincides with the pointer
4.11.4. Turn the screw knob till the tablet breaks. the pressure indicated on the dial is
    in kilogram per sq.cm.
4.10.      Disintegration:
4.10.1. Perform the Disintegration test of the required product as mentioned in the
    individual monograph and calculate the results accordingly.
    Frequency:  At Start
4.11.      Dissolution:
4.11.1. Perform the Dissolution test of the required product as mentioned in the
    individual monograph and calculate the results accordingly.
    Frequency:  At Start
4.12.    Average Weight:
4.12.1. Take 20 tablets and weight them, then note the weight of a single tablet
     according to the specification
     Frequency: At Start and after each 30 minutes
4.13.    Weight Variation:
4.13.1. 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
In-process checks for Capsules:
4.14.    Disintegration:
4.14.1. Perform the Disintegration test of the required product as mentioned in the
    individual monograph and calculate the results accordingly.
    Frequency:  At Start
4.15.      Dissolution:
4.15.1. Perform the Dissolution test of the required product as mentioned in the
    individual monograph and calculate the results accordingly.
    Frequency:  At Start
4.16.    Average Weight:
4.16.1. Take 20 tablets and weight them, then note the weight of a single tablet
     according to the specification
     Frequency: At Start and after each 30 minutes
4.17.    Weight Variation:
4.17.1. 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
4.18.    Blister Leakage Test:
4.18.1. Perform the Disintegration test of the required product as mentioned in the
    individual monograph.
   Frequency:   At Start
4.18.2. Also Check the B. No. Expiry from BMR.

5.0    QUALITY FORMS AND RECORD:

N-A





EVIDENCES OF RECORDS & REFERENCES
BMR (F-03-005)
FORMAL KPIs (Key Performance Indicators)
QC Reports at all stage of in process.
QC Release Slips.
GENERAL RISKS
CONTROL MEASURES

CUSTODIAN
Risks
Impact
Not wearing mask and gloves during manufacturing
Product may be contaminated/ hazardous to health while manufacturing  the bulk
Ensure proper usage of PPEs while handling the materials


QA Officer/
Lab Attendant

Checks not Performed Properly or after 30 mints.
Volume or weight variation Occurs. or
Dissolution failed at finished product.

Proper checks done before start and in -process.
Document each value.


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