Monday, 8 April 2013


Manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs.

Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. In spite of the fact that it is mandatory from the government and regulatory bodies, it is also a fact that quality of a pharmaceutical product can not be adequately controlled solely by pharmacopoeial analysis of the final product. Today quality has to be built in to the product right from its inception and rigorous international environmental, safety and regulatory standards need to be followed.

Albeit it is catching up rapidly, the pharmaceutical industry is trailing behind many other industries in adopting newer technologies because of the time, effort, and costs associated with the Public Administration’s approval to manufacture each drug based upon "validated processes".

Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. 

Validation has proven to be an important tool for quality management of pharmaceuticals. It is defined as "Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled". In contrast with Verification, Validation rather focuses on the question whether a system can perform its desired functions. 

The areas where validation can be applied are:
  • Analytical test methods 
  • Instrument calibration
  • Process utility services
  • Raw materials
  • Packaging materials
  • Facilities
  • Manufacturing
  • Product design
  • Cleaning and Operations

The activities relating to validation studies are classified into three phases:
  1. Pre-validation phase or qualification phase.
  2. Process validation phase or process qualification phase.
  3. Validation maintenance phase.

Conducting process validation is not only a regulatory requirement, but also makes a great deal from cutting-edge engineering to a new business point of view. It is evident that pharmaceutical companies that are versed in conducting process validation have a competitive advantage over those who are not.

The most compelling reasons to optimize and validate pharmaceutical productions and supporting processes are quality assurance and cost reduction.

The quality assurance of pharmaceutical product involves a number of factors. The complexity of modern day medical products requires more than the routine end product testing, as the end product testing is not enough to assure the quality of the finished product.

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable.

Sources: Current Pharma Research, FDA, ASQ Pharma, European Medicines Agency (EMA).

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