PHARMA KING ACE

 In pharmaceutical production, change control is a crucial process that ensures any modifications to equipment, processes, or procedures are managed systematically and safely. Here are some examples of how change control is handled in the pharma industry: Equipment Change: When a pharmaceutical company decides to replace or upgrade a critical manufacturing equipment, a formal change control process is initiated. It involves assessing the impact of the change, conducting risk assessments, and ensuring proper validation of the new equipment before implementation. Process Change: If there is a need to modify a manufacturing process, change control is employed to evaluate the potential impact on product quality, safety, and efficacy. This process includes thorough documentation, testing, and validation to ensure the changes do not compromise product quality. Raw Material Change: When there is a need to switch or modify a raw material used in drug manufacturing, change control is applie...

  MONTHLY CALIBRATION OF BALANCES  For monthly Calibration of Balances check following parameters- 1. Accuracy - verify the balance with minimum weight (least count × 100), 5%, 20%, 50%, 90% capacity of respective balance capacity. Tolerance - the variation if any should be ± least count of the balance or ± 0.2% of certified standard weight used whichever is higher    2. Reproducibility -  Check the reproducibility by using minimum standard weight of balance capacity. Place the weight in the middle of the weighing pan observe the displayed value  Then calculate the %RSD by following formula  RSD= SD×100 / X  Where,  X= mean of the individual value Acceptance = %RSD should not be more than 2.0% 3. Eccentricity  Eccentricity is the difference between the weight placed in centre and at peripheral points of the weighing pan