by Roseline Tio, Dhika Prameswari, Izwan Firdaus (SEA CSV SME), Qadly Ameen (SEA Process Validation, Pilot Scale, and CQV SME)

In the pharmaceutical industry, producing safe and high-quality products is non-negotiable. This is where Process Validation comes into play, ensuring that pharmaceutical products consistently meet stringent quality standards and customer expectations. The U.S. Food and Drug Administration (FDA) outlined the Three Stages of Process Validation in 2011 to emphasize a proactive approach to quality, efficiency, and safety throughout the manufacturing process, rather than relying solely on testing the finished product.

Stage 1: Process Design

This is the research and development phase, which includes defining a production procedure for the product. It usually consists of the following:

• Creating a Quality Target Product Profile (QTPP): Defining the intended quality characteristics of the product to ensure it meets the needs of patients and regulatory requirements.
• Identifying Critical Quality Attributes (CQAs): Determining the physical, chemical, biological, and microbiological properties that must be controlled to ensure product quality.
• Defining Critical Process Parameters (CPPs): Establishing the variables affecting CQAs and ensuring they are kept within defined limits.
• Development and process support activities leading to process validation require the allocation of internal and external resources.
• Conducting Risk Assessments: Evaluating potential risks and implementing strategies to mitigate them.
• Create process flow diagrams/detailed process description

The Process Validation stage, while requiring rigorous record keeping, also offers business benefits by improving production processes, enhancing efficiency, and troubleshooting issues through data collection and evaluation.

Stage 2: Process Validation or Process Qualification

This step ensures consistent quality levels by reviewing and certifying the manufacturing process, involving data collection and evaluation from all aspects, including building and facilities, raw material transportation, storage, employee knowledge, and working habits. It also establishes sampling sites at various stages and finalizes product packaging, storage, and distribution. It also includes creating contingency plans for potential issues. According to GMP guidelines, we were expected to offer Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services to support validation and quality processes.

• Design Qualification (DQ) defines instrument design aspects, including functional and operational specifications and vendor selection criteria. DQ can be conducted by manufacturers, developers, or end users.
• Installation Qualification includes all actions related to instrument installation. IQ determines if the environment in which it is installed is appropriate, whether the instrument meets the requirements, and whether the installation protocols were followed.
• Operational Qualification involves collecting documentary evidence showing that the installed instrument’s performance in the chosen environment will be according to the criteria specified in operational specifications.
• Performance Qualification assesses the instrument’s performance against recorded operations such as maintenance, change control, and calibration to ensure it meets its intended purpose.

Stage 3: Continued Process Verification

Continued Process Verification is a continuous process validation process used during the production of commercial products to ensure consistent quality delivery.

This stage focuses on detecting and resolving process drift through product sampling, analysis, and verification, involving employee involvement and quality control training. Comprehensive record-keeping is necessary to log anomalies and product quality issues.

Why Partner with PharmEng Technology for Process Validation:

1. Expertise and Experience: PharmEng Technology’s seasoned professional team offers unparalleled pharmaceutical compliance expertise. With years of experience, our specialists are adept at navigating the complexities of system validation and regulatory requirements.

2. Comprehensive Support: From initial assessment and strategy development to validation execution and ongoing maintenance, PharmEng Technology provides end-to-end support. Our thorough approach ensures that your systems are fully validated, compliant, and optimized for long-term success.

3. Commitment to Excellence: At PharmEng Technology, we are committed to excellence in everything we do. We uphold the highest standards of quality, integrity, and professionalism, ensuring our clients receive best-in-class service and support. With PharmEng Technology as your partner, you can trust that your process validation needs are in capable hands.

For more information, please visit our website at www.pharmeng.com or contact us at info.asia@pharmeng.com. Discover how PharmEng Technology can enhance pharmaceutical initiatives with comprehensive process validation solutions.

About PharmEng Technology

PharmEng Technology is a global consulting firm specializing in pharmaceutical engineering, regulatory affairs, and compliance. With a commitment to quality and innovation, PharmEng Technology provides comprehensive solutions to meet the evolving needs of the pharmaceutical and biotechnology industries.

Contact Information

PharmEng Technology
Email: info.asia@pharmeng.com