Qualification & Validation
Qualification and validation are critical processes that ensure pharmaceutical water purification, storage and distribution system consistently produce water meeting the purity requirements outlined in pharmacopoeias, such as USP and Ph.Eur.
Lifecycle of Pharmaceutical Water Systems Qualification & Validation
Qualification involves a series of steps to ensure that water systems are designed, installed, and operate according to predefined criteria. This includes:
- Design Qualification (DQ): Verifying that the design meets regulatory and operational requirements.
- Installation Qualification (IQ): Ensuring that the system is installed correctly and according to specifications.
- Operational Qualification (OQ): Confirming that the system operates as intended under all anticipated conditions.
- Performance Qualification (PQ): Demonstrating that the system consistently performs according to the intended operational parameters.
Validation is the process of proving that the water system consistently produces water of the required quality. This includes:
- Prospective Phase: Conducted before the system is put into routine use, ensuring that it will perform as expected.
- Concurrent Phase: Performed during actual production, providing real-time data to confirm the system’s performance.
- Retrospective Phase: Carried out on systems that are already in use, using historical data to confirm consistent performance.
- Validation Maintenance: Ongoing activities to ensure the system continues to operate within validated parameters over time.
The Importance of Documentation
Proper documentation is essential throughout the qualification and validation process. It ensures regulatory compliance, provides traceability, quality assurance and mitigate potential risk. The key elements of a comprehensive documentation includes:
- Design documents: Detailed drawings, specifications, and calculations that describe the system’s design and intended operation.
- Installation records: Documentation of the installation process, including inspection reports, acceptance certificates, and calibration records.
- Operational procedures: Standard operating procedures (SOPs) that outline the proper operation, maintenance, and cleaning of the water system.
- Qualification and validation protocols: Detailed plans that outline the specific tests and procedures to be performed during qualification and validation.
- Test results: Records of all test results, including data analysis and evaluation.
- Deviation reports: Documentation of any deviations from the planned procedures or expected results, along with corrective actions taken.
- Change control records: Documentation of any changes made to the water system, including justifications and impact assessments.
Full GMP/GDP Compliances to Global Standards and Regulations
Our team of dedicated engineers has a deep understanding of GMP/GDP regulations, qualification/validation procedures, and documentation requirements. By partnering with us, you can have peace of mind knowing that your water system is consistently delivers the purity required for safe and effective pharmaceutical products.
NPR – National Pharmaceutical Regulatory Agency
USP – United States Pharmacopeia
FDA – U.S. Food and Drug Administration
TGA – Therapeutic Goods Administration
BP – British Pharmacopoeia
Ph. Eur. – European Pharmacopoeia
ISO 13485
AAMI TIR34:2014
PHARMACEUTICAL WATER SYSTEM