Application of the Shewhart diagram to control the mean mass of tablets in the examination of manufacture process

Process validation is strictly required in good manufacturing practice. For doing so, Shewhart charts can be used effectively. In this work, two types of Shewhart charts including X-bar chart and R chart were applied to validate the production processes of Rantitidin tablets and Tryotricin lozenges. By using six rules of evaluation, the statistical process control of the mean tablet weights were clearly shown

Combination of planning optimization formula with revision before manufacture process

The objectives of prospective process validation are to evaluate the key variables and their operational ranges and to predict the "worst cases" for each investigated variable. The targets of formulation design and optimization are to establish the quantitative relationships between input variables (ingredients/ processing conditions) and output variables (product properties). There are some intersectional ideas between validation and optimization as input-output relationships, quantifiable and predictable behaviours of input and output variables, constraints of independent and dependent variables, etc. The formulation design and optimization for paracetamol tablets, in combination with process prospective validation, using the optimization and what if prediction performed by INForm v3.0 as a frame work, was successfully done to (a) determine the critical variables as well as to estimate their optimized values, (b) to investigate the variable limits as well as to predict some worst cases

Retrospective evaluation of the manufacture process of Oroken 200mg tablets

GMP requires that all procedures should be properly validated...To ensure that processes and procedures remain capable of achieving the intended results, they should routinely undergo critical approvals. To obtain this purpose, the retrospective validation is proceeded with data provided from at least 10 batches. According to a C. Estampe study, we carried out a retrospective validation with Oroken 200mg tablets produced at the Saint Genis-Laval factory of Rh«ne-Poulenc Rorer (French).

Retrospective examination of the manufacturing process of paracetamol tablets

Retrospective validation is a quality assurance tool which uses the historical data, esp. batch production records, of an existing product to provide the evidence that its process is under control. Retrospective validation does not deal with experiments but it requires systematic and comprehensive data analysis. In this work, the granule humidity content and the tablet thickness in the production process of paracetamol tablets including were validated by using Shewhart charts.