SOP For In-Process Check During Tablet Compression

SOP For In-Process Checks during tablet compression is described in this post which you can follow in the section of the Quality Assurance Department. 

OBECTIVE

This procedure has been established to outline for in process inspection to be conducted during dry tablet compression to ensure the quality of product.

SCOPE 

This procedure is applicable to the Production Department of tablet manufacturing area

RESPONSIBILITY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance 

PROCEDURE 

QA Officer ensures that area, compression machine, balance is clean and free from dust, powder or foreign matter.

QA Officer ensures that no other material except the relevant batch should be present in the area.

QA Officer checks the relative humidity and temperature recommended for the product to be compressed and Production Officer notes these on log sheet and signed by both QA and Production Officers at the time of line clearance.

QA Officer checks that the containers containing bulk powder are properly labeled indicated Name of Product, Batch No, Batch Size, Process/Status, Signature (Production Officer) and Date.

QA Officer checks that released label for compression issued by Q.C. is affixed on the bulk container/machine.

QA Officer checks the compressed tablets for mottling, chipping, sticking, capping and color variation.  

Before checking the weight variations QA Officer confirms that the balance is calibrated and also checks calibration record of the balance.

QA Officer checks that all necessary parameters i.e. tablet weight, disintegration time, friability, thickness, shape and hardness are within acceptable limits and are recorded on in-process sheet in BMR.

Weight variation is performed on 10 tablets, every half an hour, alternatively by QA and Production Officers and should be recorded on in-process sheets in BMR.

If any deviation found, it must be recorded in BMR.

If problem persists, informed the QAM and Quarantine the production. 

Special precautionary measures should be taken in case of moisture sensitive products. More emphasis should be on temperature and relative humidity during the compression of these products.