Quality Control

General:

In accordance with the AMWHV (German Ordinance on the Manufacture of Medicinal Products & Active Ingredients) and GMP Directives, the company Bela-Pharm GmbH & Co KG possesses a Quality Control Facility. The task of the Quality Control is to check pharmaceuticals and their raw materials as well as packaging materials for the appropriate quality in accordance with the recognised pharmaceutical regulations. This ensures that the respective necessary inspections are carried out and that both materials for consumption and products for sale or delivery are released in the required quality.

The main tasks are:

  • Creation of specifications
  • Inspections of raw materials, packaging materials, intermediate products, bulk goods and finished products
  • Recording and assessment of the test results
  • Release or rejection of the materials based on the test results
  • Storage of retain samples from raw materials, packaging materials and products
  • Validation of test methods
  • Stability examinations

The Quality Control Department is an area independent of the Production and all other departments at Bela-Pharm GmbH & Co KG within the scope of the Quality Assurance System.

Divisions within the Quality Control Facility:br />

Incoming goods inspections:
Sampling, testing and release or rejection of raw materials, packaging materials, sample inspections and assessment, management of retain samples.

Pharmaceuticals inspection:
Sampling, chemical and physical, inspection and release or rejection of in-process and final inspections on pharmaceuticals; inspections and assessment, management of retain samples, inspections within the scope of Quality Assurance.

Microbiology:
Microbiological examinations of the quality of raw materials, semi-finished goods, finished products, sample taking and microbiological inspections and assessment, management of retain samples. Sampling and inspections carried out within the scope of the Quality Assurance (microbiol. monitoring: production, air, water, rooms, devices, personnel etc.).

Stability testing:
Taking of samples, storage and stability tests acc. the V-ICH guidelines (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products). Assessment , documentation and archival of stability data.

Method validation:
Validation of analytical methods and method transfer, documentation creation within the scope of the official certifications.

Testing equipment management:
Testing equipment monitoring, documentation management, archival.

Requirements:

The Management of the Quality Control Facility ensures that the basic principles of the GMP Directives are maintained in Quality Control within their testing facility:

Records are kept on training and further training for all scientific and technical employees.

The inspections take place in conformance with the certification documentation, with due consideration of the status of science and technology as well as the current requirements on the field of pharmacopoeia and GMP Directives. Inspections are carried out on qualified devices using validated methods. Raw data is recorded without gaps. It is ensured that raw data, test reports and other related material is archived. The applied analysis methods and testing procedures are validated or revalidated according to the respective technological status. Validation takes place in accordance with the requirements laid down in the V-ICH guidelines (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products). Samples are taken of all incoming materials (raw materials, bulk goods, finished products) in Incoming Goods acc. the working instructions. All materials with appropriate external markings remain in quarantine until their release.

Services:

In addition to the routine inspections of raw materials, intermediate and finished products, the Quality Control takes on several services for the entire company. These include microbiological monitoring within the Production Division, supporting analytics for process validations and cleaning validations. All these activities take place according to written working instructions and, if required, these services can also be delegated to qualified, external contract laboratories.

Responsibilities:

The responsiblity for the activities of the Quality Control Division lies with the Head of Control at Bela-Pharm GmbH & Co KG.