Page 13 - ADAMAS Brochure

Our range of GMP services includes:
▪ GMP compliance auditing
▫ Drug Product (DP) - sterile and
non-sterile
▫ Drug Product—Sterile Fill/Finish (i.e. Lyophilized, Liquids (i.e. Vials, Cartridges, Pre-filled Syringes, Ampules))
▫ Drug Product—Non-sterile Fill/ Finish (i.e. Tablets, Capsules, Creams, Ointments, Oral)
▫ Combination Products
▫ Medical Device
▫ Sterilization (i.e. Gamma Irradiation, E-Beam, VHP)
▫ Batch Disposition (Qualified Person (QP), Exploitant)
▫ Service providers
▪ GMP Training/Inspection
interview training
▫ Greeting and reception, answering questions, avoiding opinion
and conjecture, preparation of documents and personnel prior to entering the inspection room
▫ Drug Substance/Active Pharmaceutical Ingredient
▫ Laboratory (Analytical and Microbial)
▫ Cell-Bank Manufacture and Storage
▫ Excipients
▫ Packaging and Labeling
▫ Warehouse, Storage and Distribution
▫ Printed Packaging Components (i.e. Labels, Cartons, Inserts)
▫ Components and Consumables (i.e. Bags, Vials, Filters, Stoppers)
▪
▪
▪
GAP analysis
▫ Interconnection of Quality Systems and compliance with regulatory filings
Facility assessments
▫ Utilities, equipment, instrumentation, calibration, preventive maintenance, and on-going monitoring of critical systems
Facility walkthroughs
▫ Upkeep, clean and use logs, calibration tags, resolution of observed issues
www.adamasconsulting.com