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In-Process Quality
Assurance
QUALITY


What is quality?



Number of definitions are available in each
guidelines

QUALITY SHALL BE DEFINED AS
CONSUM...
TABLET MANUFACTURING PROCESS
 PLM
 OPEN ENVIRONMENT
 MULTI MILL
 COMPRESSION MACHINE
 COATING MACHINE
 INSPECTION MA...
QUALITY

QUALITY IS SOMETHING APART
FROM TESTING AND
APPROVING OF
MEDICINES
QUALITY

QUALITY NOT TO BE TESTED
TO BE BUILT DURING THE PROCESS.
QUALITY
 100 % testing of medicines are not done.
 Most of the testing are destructive testing.
 All impurities are not...
QUALITY
 By means of
 Following GMP thorough out the process.
 Control over input materials.
 Process control.
 Vario...
IPQA

FAULT FINDING ?
IPQA
To assure products are consistently produced as
per quality standards and predefined specifications

To guide the ope...
Schedule M
CFR 211
Sec. 211.110 Sampling and testing of in-process materials and drug

products. (a) To assure batch uniformity and ...
CFR 211
(b) Valid in-process specifications for such characteristics shall

be consistent with drug product final specifi...
ICH Q7
EU Guideline
LINE CLEARANCE
Objective

To assure that no traces of previous product

inside

the module.

To assure that correct mate...
GENERAL CHECKS
 Area and equipment cleanliness
 Area and equipment log cards
 Clean primary and secondary

gowning
 Fi...
WAREHOUSE DISPENSING AREA
 Area and equipment cleanliness
 Area and equipment log cards
 Clean primary and secondary go...
PRODUCTION
 PROCESS
 Check all manufacturing activities are being performed

as per batch processing record.

 Process ...
SIFTING
 Check for :

 Right equipment in process as per BMR.
 Correctness of mesh /screen size.
 Black particles / fo...
GRANULATION
 Check for :
 Right equipment in process as per BMR.
 Amount of granulation fluid added.
 Time of granulat...
DRYING
 Check for :
 Right equipment in process as per BMR.
 Filter bag integrity.
 Inlet / outlet temperature.
 Bed ...
BLENDING:
 Check for :
 Right equipment in process as per BMR.
 Blender speed.
 Blending time.
 Content uniformity.
...
COMPRESSION











Check for :
Right equipment in process as per BMR.
Appearance of tablets (Correct punch )...
COATING
 Check for
 Spray pattern
 Spray rate
 Inlet /out let/ product temperature
 RPM of coating pan
 Amount of co...
PACKING
 Check for
 Forming temperature

Check for

 Sealing temperature
 Appearance of blister

 Cleanliness of cont...
YIELD RECONCILIATION
Manufacturing yield at all stages to be checked.
Any out of specification/ out of trend to be
investi...
IPQA
 Will reduce the batch rejections

 Will reduce the reprocessing

BY ADOPTING VARIOUS CONTROLS OVER THE PROCESS,
TH...
Common GMP Deficiencies
Common GMP Deficiencies
Common GMP Deficiencies
Common GMP Deficiencies
Common GMP Deficiencies
Common GMP Deficiencies
Line clearance ppt
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Line clearance ppt

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Line clearance ppt

  1. 1. In-Process Quality Assurance
  2. 2. QUALITY  What is quality?  Number of definitions are available in each guidelines QUALITY SHALL BE DEFINED AS CONSUMER NEED  When we call a medicine as quality medicine?
  3. 3. TABLET MANUFACTURING PROCESS  PLM  OPEN ENVIRONMENT  MULTI MILL  COMPRESSION MACHINE  COATING MACHINE  INSPECTION MACHINE  PACKING MACHINE  RMG  FBD  COMPRESSION MACHINE  COATING MACHINE  INSPECTION MACHINE  PACKING MACHINE  CLOSED SYSTEM BOTH ARE SENT TO QUALITY LABORATORY & GOT APPROVED? DO YOU FEEL ANY DIFFERENCE BETWEEN THESE TWO PRODUCTS?
  4. 4. QUALITY QUALITY IS SOMETHING APART FROM TESTING AND APPROVING OF MEDICINES
  5. 5. QUALITY QUALITY NOT TO BE TESTED TO BE BUILT DURING THE PROCESS.
  6. 6. QUALITY  100 % testing of medicines are not done.  Most of the testing are destructive testing.  All impurities are not detected /analysed. What to do?  Quality to be built during the process. HOW?
  7. 7. QUALITY  By means of  Following GMP thorough out the process.  Control over input materials.  Process control.  Various checks during the process (IPC).  Doier and checker system (cross checking) .  Control over product release.
  8. 8. IPQA FAULT FINDING ?
  9. 9. IPQA To assure products are consistently produced as per quality standards and predefined specifications To guide the operator / supervisor regarding any deviation observed during the process.
  10. 10. Schedule M
  11. 11. CFR 211 Sec. 211.110 Sampling and testing of in-process materials and drug products. (a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate:      (1) Tablet or capsule weight variation; (2) Disintegration time; (3) Adequacy of mixing to assure uniformity and homogeneity; (4) Dissolution time and rate; (5) Clarity, completeness, or pH of solutions.
  12. 12. CFR 211 (b) Valid in-process specifications for such characteristics shall be consistent with drug product final specifications and shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate. Examination and testing of samples shall assure that the drug product and in-process material conform to specifications. (c) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality control unit, during the production process, e.g., at commencement or completion of significant phases or after storage for long periods. (d) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which
  13. 13. ICH Q7
  14. 14. EU Guideline
  15. 15. LINE CLEARANCE Objective To assure that no traces of previous product inside the module. To assure that correct materials brought for processing / packing.
  16. 16. GENERAL CHECKS  Area and equipment cleanliness  Area and equipment log cards  Clean primary and secondary gowning  Filter cleaning  Status labeling  Online documentation  Availability of gloves & nose masks  Availability of disinfectant solution
  17. 17. WAREHOUSE DISPENSING AREA  Area and equipment cleanliness  Area and equipment log cards  Clean primary and secondary gowning  Filter cleaning  Status labeling  Online documentation  Availability of gloves & nose masks  Availability of disinfectant solution  Proper storage of actives and       execipients. Material status. Handling of materials Dispensing Tools cleaning Labeling details. Balance calibration (log books). Dispensing activity (log books).
  18. 18. PRODUCTION  PROCESS  Check all manufacturing activities are being performed as per batch processing record.  Process rate / time against specifications mentioned in BMR.
  19. 19. SIFTING  Check for :  Right equipment in process as per BMR.  Correctness of mesh /screen size.  Black particles / foreign particles.  Quantity retains over the mesh.  Sieve integrity before and after sieving.  Abnormal noise from the sifter.
  20. 20. GRANULATION  Check for :  Right equipment in process as per BMR.  Amount of granulation fluid added.  Time of granulation.  Amperage/torque, if applicable.  Formation of good granules.
  21. 21. DRYING  Check for :  Right equipment in process as per BMR.  Filter bag integrity.  Inlet / outlet temperature.  Bed / Product temperature.  Racking in tray drier / FBD.  Proper fluidization in FBD.  Formation of any lumps.  Moisture content (Sampling).
  22. 22. BLENDING:  Check for :  Right equipment in process as per BMR.  Blender speed.  Blending time.  Content uniformity.  Bulk density.  Particle size analysis.  Moisture content.  Compressibility index
  23. 23. COMPRESSION           Check for : Right equipment in process as per BMR. Appearance of tablets (Correct punch ) Average weight Uniformity of weight Thickness Hardness Friability DT Machine speed
  24. 24. COATING  Check for  Spray pattern  Spray rate  Inlet /out let/ product temperature  RPM of coating pan  Amount of coating solution  % Weight gain  Color / shade variation (different lots)  Mottling  Chipping  Orange peel effect
  25. 25. PACKING  Check for  Forming temperature Check for  Sealing temperature  Appearance of blister  Cleanliness of container / closure.  Speed of machine  Pack specification  Number of tablets / container  Leak test  Integrity of line.  Closing /opening torque.  Challenge test for sensors.  Correctness of label Check for correctness manufacturing and expiry dates
  26. 26. YIELD RECONCILIATION Manufacturing yield at all stages to be checked. Any out of specification/ out of trend to be investigated. Printed packing material yield. BMR /BPR to be reviewed at the time of sampling
  27. 27. IPQA  Will reduce the batch rejections  Will reduce the reprocessing BY ADOPTING VARIOUS CONTROLS OVER THE PROCESS, THE PRODUCT WILL BE OF QUALITY ONE BUILDING QUALITY DURING THE PROCESS, THERE BY GETTING THE QUALITY PRODUCT.
  28. 28. Common GMP Deficiencies
  29. 29. Common GMP Deficiencies
  30. 30. Common GMP Deficiencies
  31. 31. Common GMP Deficiencies
  32. 32. Common GMP Deficiencies
  33. 33. Common GMP Deficiencies

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