General
In accordance with the PharmBetrV and GMP (Good Manufacturing Practice) guidelines, bela-pharm GmbH & Co KG has a Quality Control Department. It is the task of quality control to examine the pharmaceutical drugs and their basic materials, as well as the packaging, according to the recognised pharmaceutical regulations and to ensure they meet the required quality. This guarantees that the respective necessary examinations of materials for use, as well as of products for distribution, are carried out and that the materials are approved with the required quality.
Main tasks:
- Drawing-up of specifications
- Checks of basic materials, packaging, intermediate products, bulk goods and finished products
- Protocol and evaluation of test results
- Approval/rejection of materials depending on test results
- Saving of reference samples of basic materials, packaging and products
- Validation of test methods
- Stability checks
The Quality Control Department is, in the framework of the quality assurance system, a department totally independent of manufacture and all the other departments of bela-pharm GmbH & Co KG.
Quality control areas
Quality control includes:
Delivery goods control:
Sampling, testing and approval/rejection of basic materials, packaging, type testing and evaluation, organisation of reference samples.
Control of medicines:
Chemical and physical sampling, testing and approval/rejection of in-process and end controls of medicinal products; testing and evaluation, organisation of reference samples and testing in the framework of quality assurance.
Microbiology:
Microbiological examinations of the quality of basic materials, semi-finished and finished products. Sampling and microbiological testing and evaluation, organisation of reference samples. Sampling and testing in the framework of quality assurance (microbiological monitoring: production, air, water, rooms, equipment, personnel etc.).
Stability testing:
Sampling, storage, as well as stability tests according to V-ICH guidelines. Evaluation, documentation and archiving of stability data.
Method validation:
Validation of analytical methods and method transfer, documentation in the framework of the official approvals.
Organisation of testing means:
Observation of testing means, documentation, organisation and archiving.
Quality control requirements
The management of quality control guarantees adhering to the basic GMP guidelines in its quality control tests:
Details of further training of all scientific and technical employees are recorded.
The tests conform to the authorisation documents taking into account the current status of science and technology, as well as the current requirements of the Pharmacopoeia and GMP guidelines.
Testing is carried out with suitable equipment using validated methods. All basic data is recorded.
It is guaranteed that basic data, test reports and further materials concerned with this, are archived.
The applied analytical methods and tests are validated/re-validated according to the respective current status of technology. Validation follows according to the requirements of the V-ICH guidelines.
According to work instructions, samples are taken of all incoming materials (basic materials, bulk goods, finished products). All materials, with corresponding external coding, remain in quarantine until approval.
Quality control service
Alongside the routine tests on basic materials, intermediate and finished products, quality control also takes over several services for the whole company. This includes microbiological monitoring in the product area, supporting analysis at process validation and purification validation. This follows after written instructions and, if required, these services are passed on to external laboratories.
Responsibility
The responsibility for the work of the quality control lies with the Head of Control of the company bela-pharm GmbH & Co KG. |
