The key functions of Quality Control department in the Pharma Industry are defined here for better clarity and guidance. Quality Control Laboratory is the heart of any Pharmaceutical Industry.
Key Functions of Quality Control
The laboratory (QC) is required to perform the below key functions in order to fulfill the Organization’s requirements in a GMP manner. The List of QC functions is provided below.
- The analysis of Raw Materials
- Packing materials analysis
- In-process sample analysis
- Intermediate analysis
- Finished Goods (API / Drug product)
- Stability study management, and many more.
Also, Read – Latest ICH Quality Guidelines 2023, Latest ICH Guidelines for Pharmaceuticals 2023
Analysis of Raw Material
The quality control department ensures the quality of raw materials against predetermined specifications and quality attributes by analyzing raw materials.
Analysis of Packaging Material
By performing the analysis of Packaging materials, the Quality control department shall ensure the quality of packaging material against predetermined specifications and quality attributes.
Analysis of In-Process Analysis
Analyzing the In-process material quality control department ensures the quality of in-process material against its predetermined specification and quality attributes.
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The functions of Quality Control – Analysis of Finished Product
By analyzing the finished product, the quality control department ensures the quality of the finished product against its predetermined specification and quality attributes.
Analysis of Stability Sample
By analyzing stability samples, quality control defines the shelf life of the product.
The functions of Quality Control – Lab Support
Lab support is a function of the quality control department by performing qualifying and calibrating instruments, and other analytical instruments.
Analysis of Microbiology Sample
By analyzing Microbiology sample quality control the substance/ product is meeting its predetermined specification and quality attribute.
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