Quality Control (QC) Department
QC is responsible for testing raw materials, in-process samples, and finished products to ensure they meet predefined specifications.
Key Responsibilities:
-
Raw Material Testing – Verifying the quality of active pharmaceutical ingredients (APIs), excipients, and packaging materials.
-
In-Process Quality Checks – Monitoring intermediate products to ensure consistency in production.
-
Finished Product Testing – Conducting chemical, physical, and microbiological tests to ensure final product quality.
-
Stability Studies – Evaluating the shelf-life and storage conditions of products.
-
Analytical Method Validation – Ensuring that test methods are accurate, reliable, and reproducible.
-
Environmental Monitoring – Checking cleanroom conditions and water systems for microbial contamination.
-
Documentation & Compliance – Maintaining batch records, test reports, and compliance with regulatory guidelines (e.g., FDA, EMA, WHO).
Validation Department
Validation ensures that all equipment, processes, and systems consistently produce results meeting predetermined criteria.
Key Responsibilities:
-
Process Validation – Confirming that manufacturing processes consistently produce quality products.
-
Equipment Qualification – Ensuring that production and analytical equipment are installed, operated, and maintained correctly (IQ, OQ, PQ).
-
Cleaning Validation – Demonstrating that cleaning procedures effectively remove residues to prevent cross-contamination.
-
Computer System Validation (CSV) – Ensuring software and computerized systems comply with regulatory requirements.
-
Method Validation – Ensuring laboratory test methods provide accurate and reliable results.
-
Facility & Utility Qualification – Validating HVAC systems, water systems, and compressed air quality.
-
Change Control & Risk Assessment – Assessing the impact of any changes in equipment, processes, or materials.
No comments:
Post a Comment