Commissioning

Commissioning verifies and documents equipment, systems, and facilities adherence to requirements. Review design, conduct tests, and verify performance under normal conditions. Preceding qualification and validation in the process.

Qualification

Qualification is a structured process that demonstrates and documents that equipment, systems, and facilities consistently operate within predetermined limits and tolerances. It typically consists of four stages:

Design Qualification (DQ): Ensures that the design of the equipment or system meets the defined requirements and specifications, considering aspects such as functionality, safety, and regulatory compliance.

Installation Qualification (IQ): Verifies that the equipment or system has been correctly installed, set up, and configured according to design specifications and manufacturer recommendations.

Operational Qualification (OQ): Demonstrates that the equipment or system operates as intended within the predefined operating ranges and conditions.

Performance Qualification (PQ): Confirms that the equipment or system consistently performs as intended under actual operating conditions, over an extended period.

Validation

Validation provides documented evidence for consistent results meeting acceptance criteria. Crucial in GMP environments to ensure manufacturing processes, analytical methods, and computer systems meet quality standards and regulations.

CQV is important in a GMP environment because it:

Ensures quality, safety, and efficacy by confirming intended operations consistently produce desired outcomes for manufactured products.

Helps maintain regulatory compliance by demonstrating that the organization follows GMP guidelines and meets the requirements set forth by regulatory agencies.

Minimizes the risk of product recalls, manufacturing errors, or deviations by identifying and mitigating potential issues before they impact product quality.

Provides a structured approach to problem-solving and continuous improvement, fostering a culture of quality and risk management within the organization.

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Contact Us & FAQ

    Q1. How long have you been offering services in Q&C

    Since 2018.

    Q2. Do you have in-house consultants to set up Validation requirements

    Yes, we have in-house CSA specialists.

    Q3. Is your team well versed with regulatory compliance format

     Yes, we have completed many successful projects due to our process and updates driven approach.

    Q4. What is the average experience of your consultants

    10 Years.

    Q5. How do I connect with you

    You can write to us at info@sagaxteam.com OR fill in the form on the “contact us” page and our team will get back to you.