Process Validation for Pharmaceutical Manufacturers

Quality managers in a manufacturing environment are responsible for ensuring their products meet the necessary quality standards.

Pharmaceutical manufacturers take this to a different level as the products they create directly impact the health and safety of the end consumer.

As a result, their offerings require thorough testing and examination to ensure that customers receive products that are safe and effective.

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This is where process validation comes in. The U.S. Food and Drug Administration (FDA) emphasizes and regulates that pharmaceutical manufacturers don’t cut any corners when crafting drugs and other medical products.

Through its current Good Manufacturing Practices (cGMP), the FDA provides principles and approaches that manufacturers in pharma and biotech industries should abide by to comply with the expected quality standards.

As such, manufacturers undertake process validation to ensure that they don’t fall foul of the FDA’s compliance and regulation requirements.

Process validation refers to the use of objective evidence to ascertain that a manufacturers’ systems and processes consistently lead to finished products that meet established standards and customer expectations.

For manufacturers in the pharmaceutical industry, process validation is an inescapable aspect of doing business.

Manufacturers in the highly competitive pharmaceutical industry always need to show consumers and regulators that they can provide consistently high-quality products that do exactly what they are supposed to.

Failure to provide quality products can not only impact a brand’s reputation, but also attract the FDA’s attention, leading to legal and financial challenges for the company.

Therefore, pharma manufacturers must validate their various processes to ensure that products tick all of the boxes regarding expected quality and regulatory standards.

One of the ways manufacturers can ensure processes are consistently validated is by instituting a robust process validation strategy with quality at their core. The FDA’s guidelines on validation encompass more than just in-process or end-product testing of medical products being made. Instead, it covers the drug’s entire life cycle, cutting off chances for any lax quality management efforts across the entire operation.

In some scenarios, manufacturers will turn to process verification. Despite sounding the same, there are some key distinctions between process validation and process verification.

As earlier stated, validation in the pharmaceutical industry is all about ensuring that relevant production processes adhere to established guidelines, resulting in a consistent, high-quality, and safe product that meets consumer demands. In essence, validation is an accepted methodology when key quality metrics can not be measured, tested, and verified.

Process verification, on the other hand, is used to determine with certainty if production processes and finished products conform to predetermined quality metrics and KPIs.

In short,

Process Validation = the collection and evaluation of data across a products’ lifecycle to ensure the product meets the needs of the intended end user

Process Verification = the measurement and testing of a product to ensure it meets the outlined product specifications and safety standards

Together, these procedures help ensure that manufacturers’ products meet the necessary requirements and specifications to fulfill the intended purpose.

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Since process validation encompasses a pharmaceutical product’s full lifecycle, the FDA outlines three principles as guidelines for manufacturers.

These include:

1. Process design

The first pillar of process validation is developing a commercial process for manufacturers to develop the given drug or product. Designing this commercial process requires details and knowledge obtained during the research and development phase.

Because the design phase is so early in the entire validation execution, businesses might not necessarily conform to current good manufacturing practices. However, the FDA still requires pharma manufacturers to create process designs and experiments through sound scientific principles and methods.

As such, manufacturers need to follow comprehensive documentation procedures, enabling them to record all efforts that went into designing the production process.

2. Process qualification

Here, manufacturers attempt to determine if the fledgling process design from the initial stage can be scaled up to commercial production levels. This stage includes designing and qualifying the physical premises, equipment, and utilities, ensuring that they can adequately and efficiently handle commercial production according to the set guidelines and specifications.

Furthermore, this stage also includes process performance qualification (PPQ). This entails adding trained personnel to the already-qualified premises and equipment, and letting them run the designed production process – quality control measures included – to make a product batch.

If successful, PPQ signals to the manufacturer that the commercialization process is viable. Therefore, manufacturers should have detailed documentation, including SOPs, prevailing conditions, expected outcomes, and other relevant factors.

3. Continued process verification

Once the commercial processes are qualified and implemented, the FDA stipulates that manufacturers continue adhering to cGMP including thorough data collection and detailed product documentation.

Furthermore, the continued verification process identifies aspects that fall short of the quality standards, allowing manufacturers to identify areas of underperformance and optimize processes to get back on track.

Additionally, businesses should ensure that their production premises maintain the quality conditions ascertained during the process qualification stage. Therefore, facility and equipment maintenance and utility consistency is essential for continuous improvement of process and product quality.

Many of the top pharmaceutical and medical device manufacturers across the globe use our GXP-qualified platform to guide operator activities and business processes while automating data collection, providing a detailed record of all actions taking place throughout the product lifecycle.

For example, with Tulip's electronic batch records, manufacturers can make data collection and validation a continuous, seamless part of the manufacturing process with streamlined, automated documentation as operators and machines work.

When it comes time for a batch record review, the necessary information is easily accessible, legible, and accurate. This means manufacturers are able to spend more time ensuring the quality of their product and less time worrying about human-based transcription errors.

If you're interested in learning more about how Tulip can help improve process visibility and simplify compliance, a member of our team would be happy to help—Reach out to learn more!