Monday, 16 January 2012

In Process Checks and its importance in Pharmaceuticals

                                                  
                               
In-Process Control refers to the checks performed during an activity (it can be manufacturing or packing) in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or finished product conforms to its specification. The control of equipment and environment may also be regarded as the part of in process control.
In process checks are vital as manufacturing activity itself and the same shall be performed at regular intervals. Frequency of the in process checks need to be realistic. By carrying out in process checks one can assure the product quality.
In process quality check is designed to provide early warning for quality or other problems arising during production. In Other words it is intended to provide a snap shot of the quality of the product manufactured at the factory. The objective of in process checks are both quality control and process control.
In process checks shall include following process controls.
l  Measured values obtained from process equipment. e.g. Inlet & outlet temperature of FBD
l  Measured values obtained from persons e.g. Times
l  Product attributes e.g.Weight,Hardness,friability
l  Measured values obtained from the room environment e.g. Temperature, Humidity.
Note: Rejected in process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing.
During process checks following things needs to be checked
l  Verification of the status labels on the area, equipments  & process containers.
l  Online stage wise review of the batch record (Online review).
l  Cleanliness of the area, equipment and line clearance.
l  Confirming material correctness, AR.no, quantity & vendor against the batch record.
l  Product attributes like weight variation, avg.wt, hardness, thickness, D.T, friability.
l  Monitoring environmental conditions.
l  Weight of the blend & other intermediates.
l  Checking the appearance tablet during compression & coating
l  Solution preparation.
l  Film formation and integrity.
l  Ensure machine setting parameters match with batch records.
l  Yield verification of various stages of production
l  Sampling

In Process Checks During Manufacturing
l  Ensure correct materials are brought in for manufacturing activity.
l  Check sieve integrity.
l  Ensure manufacturing is carried out as per the instruction given in the BMR.
l  Ensure operators are wearing hand gloves and nose mask during all stages of manufacturing.
l  Verify the records for online entries.
l  Environmental Monitoring.
l  Check & verify equipment parameters like temperature, drying time etc.
l  Checking process parameters like Appearance, Avg.Weight, Group Weight, Hardness, friability, DT etc.
l  Yield verification.
l  Checking the weights of in process materials.
l  Checking labeling status of the quarantine materials.
l  Ensure doors are closed during processing.
In Process Checks During packing
l  Ensure Name, Strength, Volume & quantity is correct.
l  Check the status labels on equipment, area & in process container.
l  Over printing quality.
l  Batch coding details on primary & secondary pack (B.No.,Mfg.,Exp., M.R.P.etc.).
l  Text matter on the ptd. foil & carton.
l  Verification forming & sealing temperature.
l  Ensure blisters are free from knurling defects.
l  Leak Test.
l  Pharmacopeial status of the material used is correct.
l  Mfg.License number is printed correctly.
l  Preprinted packing materials provide mandatory information & legal status.
l  Storage conditions details available in the packaging materials.
l  Directions for use details available in the packaging materials.
l  Ensure warnings against wrong administration is provided in the pack.
l   Storage condition is same all printed packing Materials.
l  Ensure correct leaflet is used for the product.
l  Verify printed matter on the outer cartons and shippers.
l  Ensure checkers are performing their activity in a proper way.
l  Verify blisters & strips for alignment defects & empty pockets.
l  Ensure doors are closed during processing.
l  Verify the records for online entries.
l  Environmental Monitoring.
l  Sampling

Documentation
Results of the in process checks shall be documented with initials of the person carrying them out and results obtained. If problems or deviations from the manufacturing formula and processing instructions occurred, all relevant information associated to this have to be documented well. 

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