- Quality System and cGMP Component:
ADCO QMS is to assure that all products are consistently produced & controlled to the quality standard appropriate to their intended use & as required by the marketing authorization or product specifications.
- Quality Management:
- Quality Policy, Quality Manual, Quality Assurance, Quality Control.
- Documentation Requirement System.
- In-Process follow up team for production department.
- Self-inspection & Supplier Qualification.
- Complaints & Recall procedures.
- Follow –up annual product review.
- Contract manufacturing.
- Non-conforming product handling.
- Quality control system.
- Quality Control System: QC is concerned with sampling, specifications & testing as well as the organization, documentation & release procedures which ensure that all tests are carried out and the materials are not released for use, nor products for sale or supply, until their quality has been judged satisfactory.
- GLP Requirements: OOS investigation
- Calibration procedures
- Reference standard handling
- Material, intermediate, bulk& finished product specification
- Handling of raw data
- Certificate of analysis
- Lab. Notebook
- Volumetric solutions& reagents
- Retained sample procedures
- Logbook
- Sampling plan, procedures & handling.
- The previous activities are out through different QC labs: QC of Raw materials
- QC of Packaging materials
- Central Lab
- In process control
- Microbiology Lab
By the help of our different devices to perform all analysis and testing required as:
- HPLC, GC, UV, Dose unit Sampling Apparatus (DUSA), Next Generation Impactor
- (NGI), etc.
- Stability studies are carried out according to ICH.
- Equipment control & Qualification: Qualification include: IQ/OQ/PQ.
Operating procedures.
Cleaning procedures.
Corrective maintenance procedures.
Preventive maintenance program.
Calibration program.
Others.