BMR CHECK POINTS THAT IPQA PERSONNEL SHOULD VERIFY DURING A ROUND ACTIVITY

 

BMR CHECK POINTS THAT IPQA PERSONNEL SHOULD VERIFY DURING A ROUND ACTIVITY:

General Information

1. Batch Number: Verify that the batch number is correctly

recorded and matches the batch being manufactured.

2. Product Name and Strength: Confirm that the product

name and strength are accurately recorded.

3. Date of Manufacture: Verify that the date of manufacture

is correctly recorded.

Raw Materials

1. Raw Material Identification: Verify that all raw materials

used are identified and recorded, including their batch numbers

and suppliers.

2. Raw Material Weighing: Confirm that raw materials are weighed accurately and recorded correctly.

3. Raw Material Storage: Verify that raw materials are stored properly and handled correctly.

Manufacturing Process

1. Manufacturing Process Steps: Confirm that all manufacturing process steps are followed and recorded, including equipment used, temperatures, and processing times.

2. In-Process Controls: Verify that in-process controls, such as pH, temperature, and viscosity, are recorded and within specified limits.

3. Equipment Cleaning and Sanitization: Confirm that equipment is properly cleaned and sanitized between uses.

Quality Control Checks

1. In-Process Sampling: Verify that in-process samples are

taken and tested according to established procedures.

2. Quality Control Test Results: Confirm that quality control test results are recorded and meet established specifications.

Deviations and Corrective Actions

1. Deviations: Verify that any deviations or abnormalities during manufacturing are reported and documented.

2. Corrective Actions: Confirm that corrective actions are taken and documented to address any deviations or abnormalities.

1. Operator Signatures: Verify that operators sign and date each step of the manufacturing process.

2. Supervisor Signatures: Confirm that supervisors review and sign the BMR to verify that the manufacturing process was followed correctly.

Additional Checks

1. BMR Completeness: Verify that the BMR is complete and all required information is recorded.

2. BMR Accuracy: Confirm that the BMR is accurate and free from errors.

3. Regulatory Compliance: Verify that the manufacturing process and BMR comply with relevant regulatory requirements.