PILOT SCALE-UP AND PROCESS VALIDATION The development of product prior to the preparation of the first pilot-production batch. The development activities are listed as follows: 1. Formulation design, selection, and optimization 2. Preparation of the first pilot-laboratory batch 3. Conduct initial accelerated stability testing 4. If the formulation is deemed stable, preparation …

WHAT IS PROCESS VALIDATION? The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment is often the result of incomplete or faulty understanding of the process’s capability, in other words, what the process can and …

Master Plan or Protocol for Process Capability Design and Testing Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-process, finished product Definition of process output Potency, yield, physical parameters Definition of test methods Instrumentation, procedures, precision, and …

Checklist of Qualification and Control Documentation The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense. Subpart Subpart Section of CGMPs Qualification and control documentation A General provisions – B Organization and personnel Responsibilities of the quality control unit C Buildings and facilities …

STATISTICAL PROCESS CONTROL AND PROCESS VALIDATION IN PHARMACEUTICALS Statistical process control (SPC), also called statistical quality control and process validation (PV) SPC comprises the various mathematical tools (histogram, scatter diagram run chart, and control chart) used to monitor a manufacturing process and to keep it within in-process and final product specification limits. There are …