GMP-EU are principles and standards that need to be ensured in the entire production process from input materials to final product evaluation. Therefore, quality control in EU GMP is to check all steps in the production process. Let’s learn how to distinguish quality assurance (QA) and quality control (QC). General regulations on quality control in the EU GMP.
1. The difference between QA and QC
Quality Assurance in EU GMP (Quality Assurance – QA) is the department that ensures the manufactured product will meet the quality requirements as registered. Through the work related to building systems, production processes, quality management and monitoring and measuring the implementation of the set quality standards.
Quality Control in EU GMP (Quality Control – QC) is the department that directly checks each stage in the production process from input materials to finished products, semi-finished products to ensure that pharmaceutical products always meet the required quality.
QA and QC are both related to pharmaceutical quality management. However, QA is responsible for covering the entire production activities of the facility and factory, while the QC department is directly involved in quality checking and perfecting products before being circulated on the market.
Depending on the size and organizational chart of each company or enterprise, these two departments can be combined or separated. In benchmarking systems, they are often separated to ensure effective formulation and monitoring in pharmaceutical quality assurance.
Learn more: Benefits of building a factory that meets GMP EU
2. General provisions on quality control in GMP EU
Good manufacturing practice standard GMP-EU has set out the general regulations to be met for quality control at factories and production facilities as follows:
– Each manufacturing facility and factory must have a Quality Control room under the quality control department. This department must operate independently of other departments and be managed by staff with sufficient expertise and practical experience. Having the necessary resources to successfully complete the plan and assigned work. All activities of the quality control room must be carried out according to the prescribed procedures and recorded. An external laboratory may be used in accordance with the inspection guidelines but must be contracted for and documented in the quality control records.
– Quality control in GMP-EU for the assessment of finished product quality including all relevant factors. From production conditions, production process, production record review to finished product standards and final complete packaging quality check.
– In some cases, quality control personnel may directly visit the production area to take samples and investigate.
The independence between quality control in the EU GMP and the production department is fundamental to effective quality control. Good implementation of Quality Control in EU GMP for all steps in the production process will help businesses always ensure the quality of pharmaceutical products and minimize costs incurred in the production process.
We always hope that GMP EU Design and Consulting Joint Stock Company will be a companion with companies and enterprises on quality control in EU GMP.