Redator Kivalita em 1 de July de 2022 em Articles

Quality management: validation of cleaning and processes in a strategic way in the manufacture of pharmaceutical products

By Bárbara Guelfi (founder and CEO of Kivalita Consulting)

For any industry, production lines include numerous factors for which managers should be aware. Especially with regard to quality management, it is vital to ensure the manufacture and delivery of products accordingly not only in relation to the standards established by the company itself, but especially with regard to the Good Manufacturing Practices (BPFs) required by the market.

For the pharmaceutical sector, specifically, there are several requirements of BPFs and, among them are validations for the production lines, be what we call “process validation” – which is the evaluation of yield, production standardization, etc . – and “cleaning validation” – which is the pointing, prevention and action on residues and contaminants on the production line.

Thus, the difference between them is that process validation standardizes and defines the criteria (yield and productivity, among others); while cleaning validation ensures that these processes have no residues (such as detergents and products), or microbiological contamination in manufacturing.

The criteria for these validations can be defined from a “pre-study” by the manufacturer and related to a computerized system, used in production lines. Both validations are challenging, and it is the responsibility of all those involved – and not just quality specialists – to be aware of the points that must be improved in the production lines. 

If the company has more than one product manufactured on the same production line, in the pharmaceutical area it is necessary to validate each of them individually. In other areas of the market, a process called “worst case” (or, in the Portuguese: “the worst case”), is carried out in which the product to be validated to represent the others must be the one that most challenges the manufacturing process in terms of toxicity, yield, etc.  And in the case of “worst case” for cleaning, viscosity, solubility, etc. are considered.

For all validations it is critical that they are repeatable, reproducible and robust (RRRs). Although we speak here specifically for the pharmaceutical industry, these criteria are also applicable to other areas of Life Sciences:

  • Repeatable: for visibility into similar results, even in subsequent production processes.
  • Reproducible: even if equipment and tanks are  changed, etc., it is necessary to ensure that the results are similar according to the same repeatability criteria.
  • Robust: Even with the exchange of people or teams between shifts, it is necessary to ensure results similar to the criteria established in the manufacturing processes of pharmaceutical products.

However, it is true that to perform them it is necessary competence, as well as for the definition of validation criteria in a way that does not impact the productive performance or day-to-day performance of operational teams. Therefore, developing a good strategy aligned with the business objectives is essential.

Moreover, if we talk about cosmetic products, for example, most do not have compendiais methods for reference in the elaboration of such criteria, and each of them has its own specificity in particular – which is a challenge when performing validations, hence the need for qualified and competent professionals in the issue.

Specialized Manpower

A good strategy not to impact the business and, at the same time, have high competence in process validation or cleaning validation is not to make use of the time of internal teams, to perform such validations, because the company’s employees are already compromewith their daily tasks – and, this can impact the work routine as a whole.

We at Kivalita Consulting, as a Brazilian consultancy specialized in the development of quality management and technology validation for companies in the area of Life Sciences, offer professionals specialized in the area of process analysis and validation, and cleaning for the pharmaceutical industry.

Talk to us and learn more about applying the outsourced hiring modality – from assistants to managers, with exclusive and proprietary periodic supervision and training – so that your teams can stay focused on business-critical activities, while our professionals take care of the validations necessary to keep their production lines compliant and with operational excellence!

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