Service
Validation/Qualification
Validation
Validation and Qualification is a key APC service and we are competent in Facilities and Utilities, Process Equipment, Cleaning and Computer System Validation, in accordance with international regulatory standards for pharmaceutical and medical devices.
Quality Risk Assessment (QRA)
APC professionals are adept at the application of risk analysis and quality risk management in industry.
Qualification
APC has senior practitioners in writing and executing URS, FDS, DQ, IQ, IQ, PQ protocols, reports and documentation tailored for Facility, HVAC, Equipment, EMS, Purified Water, Utilities, Pure Steam and Compressed Air Systems.
GMP, Quality and Quality Systems
APC can provide guidance with compliance to regulatory requirements such as FDA, PIC/s, TGA, ISO9001 and ISO13485.
GMP Consulting and Engineering
Our GMP services include feasibility study, master planning, facility, services and equipment design, all aspects of project management, audit guidance, qualification and validation.
Project Management
APC provides GxP project management services including project delivery strategy, design and tender documentation, project timeline and cost control, construction, testing and commissioning, planning and support and validation activities.
Quality Auditing
Auditing to a standard required by the Therapeutic Goods Administration (TGA), Food and Drug Administration (FDA), European Agency for the Evaluation of Medicinal Products (EMEA) and the Medicine and Health Care Products Regulatory Agency (MHRA) is available.
Training
APC can provide training covering PIC/S, EU, UK & FDA GMP Compliance. Training can be delivered on site or virtually.