Performance Qualification in Pharmaceutical Industry: Your Guide

Performance qualification focuses on the practical application of the pharma equipment and system during manufacturing processes. Certain minor issues do not show up during the operational qualification phase. However, they can cause serious setbacks when the equipment is used under full load during actual production. Hence, performing a thorough performance qualification in pharmaceutical industry is vital. Performance qualification (PQ) is the final stage of the equipment qualification process.

What is performance qualification in pharmaceutical industry?

Performance qualification validates whether the equipment consistently performs as per the required specifications during the actual production process. It is performed after the installation qualification and operation qualification phases. Performance qualification in pharmaceutical industry verifies whether the equipment will consistently produce pharmaceutical products per quality standards and regulatory requirements. Basically, it validates the equipment will consistently perform as intended during real production conditions. Performance qualification (PQ) aims on assessing the practical application of the pharma equipment. This necessary for ensuring consistent product safety, efficacy, and quality. Hence, this final stage of the equipment qualification process verifies whether the user and regulatory requirements are being fulfilled during actual conditions. Usually, PQ has two parts:

1. Design of the facility and qualification of the equipment and utilities
2. Process performance qualification (PPQ)

Practical examples of performing performance qualification in pharmaceutical industry: Performance qualification is performed to demonstrate an autoclave is performing as expected (producing sterilized products) in actual conditions. The autoclave is subjected to several cycles of sterilization with real load. Then, the sterilized load is checked for uniform sterilization, any damage, or loss of efficacy. Another practical example is PQ of a packaging line. The packaging line is used to continuously seal blister packs. The seal integrity and alignment across multiple batches are continuously checked.

PQ protocol

A detailed PQ protocol has to be created. It should provide a framework for assessing how the equipment and system perform under actual operating conditions. Additionally, acceptance criteria have to be formulated. The acceptance criteria will detail specific parameters for determining whether the equipment meets the required operational performance benchmarks. The PQ protocol should include the following:

• Tests to be conducted to confirm consistency in product quality during the actual production process.
• Manufacturing conditions as well as the processing limits, component inputs, and operating parameters.
• Sampling plan stating the methods of sampling to be used during and in between the production batches.
• Description of the variability limits as well as the contingency plan for handling nonconformance.
• The necessary data that has to be recorded as well as how and when will it be evaluated. Additionally, the analytical methods to be used to make data-based decisions.

Importance of performance qualification in pharmaceutical industry

Performance qualification plays a crucial role in ensuring high-quality pharmaceutical products are consistently manufactured.

1. Consistency in product quality: PQ has a vital role in ensuring consistency in product quality by verifying whether the equipment consistently and reliably performs as intended. Additionally, it helps ensure uniformity in each batch of pharmaceutical products manufactured.
2. Regulatory compliance: Most regulatory authorities require pharma companies to perform PQ. Performance qualification is conducted to demonstrate compliance with GMP guidelines and regulatory requirements.
3. Process optimization: PQ will provide insights into areas for improving operational efficiency and minimizing wastage, thereby it will contribute to developing a robust manufacturing system. Hence, performance qualification plays a role in process optimization.
4. Risk mitigation: Performance qualification helps identify and address any potential issues associated with real world usage of the equipment prior to full-scale production. Thus, it will reduce the likelihood of costly recalls or regulatory penalties by mitigating quality risks associated with equipment flaws.
5. Patient safety: By validating the performance of equipment during actual production conditions, PQ minimizes the risk of producing defective or unsafe pharmaceuticals. Thus, it has a role in ensuring patient safety, which is the top focus of pharma companies.

8 key steps of implementing performance qualification in pharmaceutical industry

1. PQ protocol development: Define the scope, objectives, and acceptance criteria for the performance qualification phase. Then, create a detailed protocol covering the test procedures, equipment details, and data to be recorded.
2. Verification of equipment installation: Verify whether the equipment is installed correctly and aligns with the design specifications. Additionally, confirm the pharma equipment is operating under standard manufacturing conditions.
3. Equipment calibration and pre-testing: Verify whether all measuring devices and instruments are calibrated properly.
4. Execution of tests under actual or real-world conditions: Perform tests under actual production conditions as per the predefined protocol. Additionally, assess parameters, such as temperature control, pressure, speed, and product quality. Check whether the equipment is performing as intended under real-world conditions.
5. Data collection and analysis: Record the findings from each test conducted. The data obtained has to be thoroughly analysed.
6. Identification and resolution of issues and deviations: Investigate any deviations or failures identified during testing. Implement corrective actions to resolve issues. Then, if necessary, repeat the tests to ensure compliance.
7. Prepare a detailed report: The PQ report should include all findings, test results, and observations. Additionally, include inputs on whether the equipment, system, or process meets the predefined qualification criteria.
8. Secure approval from concerned departments: The final performance qualification report has to be approved by the quality assurance team, validation team, and any other relevant department.

Challenges faced while implementing PQ in pharma industry

1. Variations in pharma equipment performance under different conditions can complicate the performance qualification process.
2. Staying abreast with the evolving regulatory guidelines for equipment qualification.
3. Unexpected deviations from the predefined PQ protocol can derail performance qualification in pharmaceutical industry.
4. Performance qualification is resource-intensive, time-consuming, and laborious.
5. Effective collaboration among departments, such as quality assurance, engineering, and production, is essential but can be difficult to achieve.
6. Accurate and reliable data recording can be challenging, especially in highly regulated pharma environments.
7. Limited availability of skilled personnel and equipment can hamper the smooth execution of PQ.

We have listed some of the common challenges of conducting performance qualification in pharmaceutical industry.

How to overcome common performance qualification challenges?

We have provided some tips to help you overcome common performance qualification challenges faced in the industry.

• Perform preliminary tests to identify any potential equipment variability. This will help address the issues before formal implementation of PQ.
• Prepare detailed, clear, and well-documented PQ protocols to minimize deviations and confusion during execution.
• Have proper plans in place to address unexpected challenges, such as equipment failures or deviations, faced while performing PQ.
• Invest in skilled personnel, necessary resources, and sufficient materials to avoid resource constraints during implementation of PQ.
• Provide ongoing training to personnel involved to ensure they are well-equipped to handle the PQ process.
• Encourage effective communication and coordination among all concerned departments, such as quality assurance, engineering, and production.
• Implement robust data management systems to ensure accurate and reliable documentation of test results and findings. Place special emphasis on proper data recording and integrity. 

Therefore, performance qualification in pharmaceutical industry plays a critical role in ensuring consistency of product quality. However, executing PQ in pharma industry is cumbersome, resource-intensive, and challenging. With the support of industry experts, performing PQ can be hassle-free. Moreover, the equipment qualification process is a mandatory requirement for most regulatory authorities. We understand every business has unique requirements and faces its own set of challenges. Hence, we provide customised regulatory support and develop specific protocols for our clients. Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will help you seamlessly navigate the equipment qualification process.