Pharmaceutical Quality System (PQS) incorporating such key elements as process performance and product quality monitoring system, corrective and preventive action (CAPA) system, change management system and management review ensures the release of safe products of proper quality.
INFAMED K takes risk-based approach to decision-making in regard of process performance and product quality. Acquired product and process knowledge management allows for mitigating quality risk.
Supplier and provider qualification procedure ensures that materials used in production are purchased only from approved suppliers. Quality agreements signed with all approved suppliers define the acceptable level of quality of the materials supplied and the means of ensuring and maintaining it.
Effective customer feedback system is part of INFAMED K PQS. We appreciate any information about the quality of our products received from distributors and patients, as it helps us and our products to get better for you.
Data governance is performed according to Data Integrity Policy, which means that data used for decision-making in regard of process performance and product quality, are attributable, original and accurate.
quality control
Quality Control (QC) is the part of GMP which is concerned with sampling and testing against approved specification, ensuring that raw and starting materials permitted to be used in production are properly tested and finished product is in accordance with approved specification.
Testing is carried out in the own chemical and microbiology laboratories, in-process control os performed at all production steps. This approach ensures independent control of the released products. Quality Control includes the following:
- Testing raw and starting materials against specification at incoming control
- Testing process fluids and gases against specification
- In-process control at all production steps
- Microbiological environmental monitoring
- Testing intermediate, bulk, prepacked and finished product against specification
- Analytical/microbiological methods validation/verification
- Material and product status management
- Reference and retention samples management
- Substance and product stability studies: long-term, accelerated, stress testing
quality assurance
Quality Assurance (QA) enforces the regulatory compliance of company systems and processes. It is assured through implementation, maintenance and continuous improvement of pharmaceutical quality system, continuous personnel training and process performance, and product quality monitoring system. Digitalization of such pharmaceutical quality system processes as GxP documentation management, change management and CAPA management guarantees high effectiveness and transparency of decision-making process.
Process validation and equipment and system qualification assures the release of products of the desired quality. This approach allows to respond quickly to changing customer and regulatory requirements, ensure proper control over any changes in process, materials, and equipment, and ensure that quality is not negatively impacted. Quality Assurance includes the following:
- Deviation management;
- Internal audit management;
- Corrective and preventive action (CAPA) management;
- Supplier management;
- Complaint and recall management;
- Documentation management;
- Change management;
- Quality risk management;
- Training management;
- Outsourcing management;
- Validation and qualification;
- Product quality review;
- Management PQS performance review.
