Pharmaceutical manufacturing is a large and complex process. Contamination in any area of the manufacturing process can result in a negative impact on product quality.

In order to prevent contamination, validation is used throughout the manufacturing process, including critical areas such as clean rooms and software applications

A thorough validation includes testing, inspections, reviews, audits, and comparisons with existing processes.

The goal of these various types of validation activities is to ensure that all records and data are true and accurate so that any necessary changes can be made to the processes involved. 

Why Start with Validating? 

The FDA’s primary goal “is to help patients have access to safe medical products.” As a result validation procedures serve this purpose by ensuring product quality and safety for the public.

Validation is the key to pharmaceutical manufacturing operations because it helps to avoid costly delays and recalls, ensures products are safe for use, regulatory compliance, meeting appropriate standards of quality, and promotes the more effective use of equipment, materials, personnel & procedures. 

Validation is an important part of pharmaceutical manufacturing because it keeps everyone accountable and increases safety for the public by making sure processes are working as they should.

It also saves companies money in terms of costs and time spent fixing problems that could have been prevented with validation inspections and tests.

Auditors can find any potential errors or issues before they become a problem and impact the quality of the product made.

Validation Cycle

There is a lot more to validation than meets the eye. For example, a validation life cycle represents the series of activities, tests, and inspections that are performed to make sure the production process is working as it should.

The validation cycle includes: 

  • Establishment of a program
  • Written procedures for manufacturing equipment, utilities, or processes
  • Determination of the tasks requiring qualification and testing
  • Selection of qualified individuals who will perform each task under supervision before they do so on their own. 

These people must be trained and fully understand how the task should be performed and why. They must also understand what steps need to follow afterward in order to ensure acceptance by management officials.

This step helps to reduce the number of errors made by technicians while performing these tasks since they know guidelines through training and understanding.

Once qualified individuals have successfully completed all required tests, they must be monitored to continue performing their tasks as expected.

Inspections and Audits

In addition to validation testing, the FDA has also been emphasizing the need for more thorough inspections, especially of critical areas in a pharmaceutical manufacturing operation.

So if you are looking to start working in this branch of the healthcare business you should remember this. Inspectors use a risk-based approach that takes into account an area’s importance within a company’s whole operation.

Areas that manufacture products with the most critical and complex manufacturing and testing requirements will receive very thorough inspections.

However, areas such as warehouses, CSR (customer service representatives), and clinical trial sites will be inspected less thoroughly since they do not affect the quality of the product made or its characteristics. 

Even if an area is not often inspected, the FDA still expects evidence of validation in order for it to be considered compliant.

Validation of drugs is required by the FDA to approve new drugs, but it is also recommended for the drug manufacturing process.

Validation must be done each time new or modified equipment or procedure is implemented in the production processes of pharmaceutical manufacturing.

Each time there are large changes made to an approved method, they need to be validated as well.

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Validation Tests 

Each validation test includes:  

Test Parameters

Specifying how observations will determine whether or not tests are completed successfully or if there is room for improvement.

For example, what colors, temperatures, volumes, etc. are required to say that a test has passed?

Let’s use temperature as an example once more since it can have so many different uses within various aspects of validation testing procedures.

Temperature is important because it can affect the outcome of a product. For example, if there is too much heat then certain components such as proteins will not bond with each other and work correctly. 

Acceptance Criteria

What observations will be recorded to say that a test has either passed or failed?

For example, temperatures might range from 1 degree Celsius to 255 degrees Celsius and anything outside of those ranges would fail the test and need further improvements made before continuing on with production processes.

It’s also vital for observation guidelines to be written down in order to avoid any errors.

This way there won’t be any confusion about what has been observed or recorded into documentation within testing areas.

It is important to underline once again that validation requires scientific judgment and must be carried out by qualified individuals who are familiar with the process.

A successful validation ensures that processes, equipment, and documentation will produce a product of high quality.

Validation is not just an important part of the Quality Assurance department for pharmaceutical manufacturing, it’s also required by law in order to keep manufacturers compliant with standards set forth by the FDA.

Once proper validation has been completed and approved by QA officials within a company, production processes can continue without interruption or delays due to incomplete assessments or inaccurate data.

This way companies can be assured that they are producing safe products for their customers, which is one of their top priorities when operating under strict regulatory guidelines provided by governing bodies such as the FDA. 

In this article, we have explained why validating before making changes to your processes could save you time by avoiding unnecessary rework or make improvements faster with better knowledge about what needs work on first.

Furthermore, validation cycles can help reduce costs since all stakeholders will know which part of the production cycle has been validated first as well as when other parts need validation next- allowing them more control over resources being used across various departments within the organization. 

Inspections and audits also play an important role in validating your processes.

They can be more of a risk for non-validated companies, but having them in place (and executed) will help demonstrate compliance to regulatory bodies such as the FDA or European Medicines Association (EMA).