B
B GMP & Compliance
ATP-CGPharm Group offers a broad range of QA, QC and technical compliance support and consulting services.
Our highly experienced engineers, pharmacists and technicians, who are perfectly familiar with the GxP Regulations, can support the different departments of your company.
B QUALITY ASSURANCE
Elaboration or improvement of your Quality System according to the newest GMP regulations
> Evaluation of Quality Systems
> Elaboration or revision of SOP’s or other quality documents
> Handling of deviations
> Handling of Change Controls
> Elaboration and follow up of preventive and corrective action plans
> Supplier audits
> Internal audits
> Preparation of audits from the international authorities
> QP services
> GxP-compliance evaluation of existing plants and installations
> …
B QUALITY CONTROL
From the elaboration or improvement of your documents to the development and validation of analytical methods
> Elaboration or revision of SOP’s
> Development of analytical test methods
> Validation of analytical test methods
> Performance of analysis
> GMP-compliance evaluation of existing QC laboratories
> …
B PRODUCTION
Elaboration or improvement of your documents
> Master Batch Records
> Equipment procedures (use, cleaning, calibration, maintenance)
> Cleanrooms cleaning and disinfection procedures
> Gowning procedures
> Material- and personal flows
> GMP-compliance evaluation of existing plants and installations
> …
BENVIRONMENTAL MONITORING
> Cleanrooms
> Cleaning operations
> Purified water
> Water for injection
> Pure steam
> Compressed air
> Process gases (nitrogen, O2, CO2)
> …
B CLINICAL TRIALS
Support in the following areas
> GMP for the manufacturing of investigational medicinal products
> Elaboration of IMPD’s
> Choice of contract manufacturing companies for the production of investigational medicinal products
> Supplier audits