Pharma IT Insights
Equipment Qualification in Pharma
By Rojan Demirtas
March 14, 2023
Pharma IT Insights
Equipment Qualification in Pharma
By Rojan Demirtas
March 14, 2023
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Equipment Qualification is critical in the pharmaceutical industry. In this Pharma IT Insight, Rojan Demirtas provides a high-level description of the equipment qualification process, the expertise required to do it successfully, and the biggest challenge facing the life sciences industry’s ability to do so.
What is Equipment Qualification in Pharma?
Equipment Qualification is part of the broader validation process. Equipment Qualification, however, addresses explicitly introducing new equipment, systems, or utilities into the manufacturing process. It is a systematic approach consisting of inspections, tests, and assessments.
The Equipment Qualification process aims to ensure that a system, equipment, or utilities have been installed, operate, and perform as intended. This includes identifying and mitigating risk to patient safety and product quality to an acceptable level and ensuring equipment complies with current regulatory requirements and industry standards.
Non-compliance with regulatory requirements and industry standards can cost manufacturers their license to operate. Equipment qualification is just one of many processes that pharmaceutical
manufacturers use to meet the quality requirements laid out in to comply with regulatory standards like good manufacturing practices (GMP).
Since most modern manufacturing equipment contains an IT system that controls and documents various processes, the equipment qualification process must also ensure data integrity. Data Integrity refers to the accuracy, completeness and consistency of data generated throughout the entire life cycle of the equipment/system.
Strict regulatory guidelines require that all data generated during the equipment qualification process must be accurate, complete and trustworthy to ensure and document that the equipment is capable of producing high-quality pharmaceutical products consistently. Without accurate, complete and reliable data it is impossible to determine whether the equipment is functioning correctly and producing products that won’t harm patients.
What kind of expertise is required to complete the validation and qualification of equipment in the pharma industry?
Equipment Qualification & Validation projects require a wide array of competencies, which varies depending on the project. However, at least 4 typical roles are found on most validation teams: Operation Responsible, Engineering Responsible, Quality Assurance Responsible, and Technical Expert.
1. Operational Responsible: A subject-matter expert (SME) in the operated business process and has the overall responsibility of planning and executing tests, protocolling, reporting test results, specifying acceptance criteria and requirements, documenting validation deviations, and creating an overview of validation documentation.
2. Engineering Responsible: Has SME knowledge within good engineering practices and is responsible for supplier selection and assessment. They will also provide design and engineering specifications, as well as approval for validation plans and reports.
3. Quality Assurance (QA) Responsible: Appointed by the organization to perform quality assurance, which involves having general quality oversight regarding GMP compliance, including safeguarding patient safety and product quality. The QA will also be in charge of approving predefined decisions and documentation, as well as granting final approval and release of the system/equipment/utility/process in scope.
4. Technical Expert: Has SME knowledge on elements of the system/equipment/utility/process and can be brought in to contribute with expertise and support the operational responsible and engineering responsible throughout the project.
To improve efficiency, one person can hold several of the roles listed above if the person fulfills the responsibilities of each role. Additionally, each role can be fulfilled by more than one person if the responsibilities lie within defined criteria in the organization and are clearly defined. Also, specific tasks related to a role can usually be delegated. This is true for all but the QA role, which should be held by one person.
Do you need assistance with Qualification & Validation of Manufacturing Equipment?
Do you need assistance with Qualification & Validation of Manufacturing Equipment?
Pharma IT consultants help fill the expertise gaps on your Validation Teams and help ensure you ensure compliance
The life-science industry is facing a shortage of experienced personnel for Manufacturing Equipment Qualification
The aftermath of the COVID-19 pandemic, the ongoing Russian invasion of Ukraine, and high inflation have caused the slowing of hirings in many industries. The life sciences industry, however, is experiencing an even higher demand of talent as new products emerge and demand for existing products continues to grow.
With the current pace of development and manufacturing of pharmaceuticals, companies are facing a shortage of personnel within the qualification and validation area. This shortage has increased the risk of market and manufacturing delays. To overcome this challenge, companies must be proactive and review their current staffing strategies.
If current recruitment strategies are unsuccessful in meeting rising existing demand, companies should both look inward and outward for talent. For example, by shifting existing staff where possible by upskilling their existing personnel with Validation/Qualification and Good Manufacturing Practice (GMP) training.
Where internal upskilling isn’t possible, companies should consider using external resources to fill gaps on their validation teams. Experienced consultants bring years of invaluable industry experience onto your project and can fuel faster turnover of results, project execution within deadline, and compliance in the daily production.
If you are looking to supplement your internal personnel with external resources, Pharma IT has an experienced team of Manufacturing Consultants that can assist you. If you’re interested in learning more about how we can help, reach out to info@pharmait.dk.
Sources:
https://www.pharmexec.com/view/despite-slowing-economy-demand-for-pharma-talent-rises
https://medwatch.dk/samfund/article14605586.ece
https://blog.boracorpcdmo.com/blog/what-you-need-to-know-about-equipment-qualification
https://www.pharmaceutical-technology.com/sponsored/pharmaceutical-qualification-and-validation/
https://www.pharmatimes.com/web_exclusives/exploring_validation_and_data_integrity_in_pharma_1246876
https://ispe.org/pharmaceutical-engineering/ispeak/why-data-integrity-critical-pharma-industry
About the author(s)
Rojan Demirtas is a Pharma Consultant with certifications in GMP, Qualification of Equipment, and GAMP5 Computer System Validation (CSV). He works within GMP compliance, implementation of procedures and processes on projects, and cleaning & sterilization validation in pharma manufacturing.
