TQM in drug industry || total quality management

 

TQM IN DRUG INDUSTRY


  • The term "quality" is not commonly defined in pharmaceutical literature.
  • Most definitions make the implication that the drug product must satisfy consumer needs.
  • Customers are unable to accurately evaluate the quality of their medications, thus governments must step in with rules and regulations to guarantee the quality of medicines.
  • The majority of rules governing medications were passed as a result of catastrophes that occurred when patients received drugs that were contaminated, improperly handled, or erroneously labelled, according to a study of the history of drug regulations.
  • As a result, pharmaceutical companies began to concentrate on quality control, the process of evaluating the standard of goods produced in their facilities.
  • It was eventually understood that no process is faultless all the time and that there are drifts from the usual functioning as time went on and pharmaceutical processes became more sophisticated.
  • Even the most effective testing techniques could fail to identify a problem since only a small number of randomly selected samples can be evaluated due to the destructive nature of testing.
  • Thus, it became clear that depending solely on product testing at the conclusion of the production process is an inefficient (and expensive) approach to try to ensure quality.
  • Global regulatory organisations define high quality drug products as those that can consistently produce the expected clinical outcomes.
  • Consumers of medicines need to be certain that the pharmaceuticals they are using are of high quality, secure for consumption, and capable of curing their illness.
  • Only if this quality is incorporated into the products from the very beginning of the design process can it be ensured.
  • The International Conference on Harmonisation (ICH), which was founded in 2002, introduced the idea of "Quality by Design," or QbD, after realising this fundamental idea.

Quality by Design

  • The ICH guideline Q8 (R2) Pharmaceutical Development defines QbD as,

"A systematic approach to development that begins with predefined objectives, emphasises product, process understanding, and process control, based on sound science, and quality risk management."

  • Understanding product features and studying process characteristics utilising a combination of prior information and experimental investigations is crucial to achieving the goal of QbD.
  • It is feasible to determine which starting material quality parameters are most crucial and which crucial processing aspects need to be managed in order to produce a product with all the specified quality attributes using the data obtained during product development.
  • The ICH Q10 guideline says that a Pharmaceutical Quality System is one that

“Ensures that the intended product quality is consistently fulfilled and that the appropriate process performance is attained. The controls are appropriate, possibilities for improvement are found and assessed, and the body of knowledge is continuously growing.”



In other words, a robust pharmaceutical quality system is the key to supplying customers with high quality drugs.

Such a system has the following characteristics:

  • ·      Aligned with requirements of current Good Manufacturing Practices (cGMP)
  • ·      Science-based and risk-based
  • ·      Comprehensive
  • ·      Proactive and accountable

The creation of such pharmaceutical quality systems is essential for effectively satisfying patient needs. These systems also help to boost regulatory bodies' trust in the organization's commitment to quality because they consistently provide high quality.




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