Pharmaceutical Process Validation

Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Quality cannot be adequately assured by in-process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Validation of the individual steps of the processes is called the process validation. Different dosage forms have different validation protocols. Process Validation is one of the important steps in achieving and maintaining the quality of final product. It gives a higher degree of assurance.

The worldwide pharma process validation advertise has developed to $39.4 billion in 2014 from $29.3 billion in 2013. The market is required to develop at a five-year compound yearly development rate (CAGR) of 13.8% from 2015 to 2020, expanding from $50.6 billion in 2015 to $96.6 billion in 2020.

  • Process Validation and Drug Quality
  • Approach to Process Validation
  • Statutory and Regulatory Requirements for Process Validation
  • Types of Process Validation
  • Validation Protocol and Report

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