Validation and cGMP

What is the purpose of cGMP?

To ensure products are consistently produced and controlled according to quality standards, ensuring safety, efficacy, and quality.

Name three key principles of cGMP

1. Proper facility and equipment design.

2. Thorough documentation and record-keeping.

3. Training of personnel.

What is validation in pharmaceuticals?

The process of proving that a system, process, or equipment consistently produces results meeting predetermined specifications.

What are the three types of validation?

1. Process Validation.

2. Cleaning Validation.

3. Analytical Method Validation

What does IQ stand for?

Installation Qualification.

What is the purpose of IQ?

To verify that equipment is installed correctly according to manufacturer specifications and design requirements.

What does OQ stand for?

Operational Qualification.

What is tested during OQ?

The equipment’s functionality under operational conditions to ensure it operates within specified limits.

What does PQ stand for?

Performance Qualification.

What is the purpose of PQ?

To demonstrate that the equipment consistently performs as intended in real-world conditions.

What is 21 CFR Part 11?

An FDA regulation that sets rules for electronic records and electronic signatures

What is the purpose of 21 CFR Part 11?

To ensure data integrity, authenticity, and confidentiality in electronic systems.

Name two key requirements of 21 CFR Part 11.

1. Use of secure, auditable electronic systems.

2. Implementation of access controls and audit trails.

What does CAPA stand for?

Corrective and Preventive Actions.

What is the purpose of CAPA?

To identify, investigate, and resolve quality issues, preventing their recurrence.

What are the steps in the CAPA process?

1. Identify the issue.

2. Investigate the root cause.

3. Implement corrective and preventive actions.

4. Monitor effectiveness.

Explain ALCOA+ and its principles.

• ALCOA:

  • Attributable: Data must be traceable to the person who generated it.

  • Legible: Data must be clear and readable.

  • Contemporaneous: Data must be recorded at the time of the activity.

  • Original: Data must be the first record (not a copy).

  • Accurate: Data must be free from errors.

• ALCOA+ adds:

  • Complete: All data must be included, with no omissions.

  • Consistent: Data must be consistent across all records.

  • Enduring: Data must be durable and accessible for the required retention period.

  • Available: Data must be accessible for review and audit.