Service
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.
APC has managed site relocation projects and associated product transfers successfully. Procurement of critical high tech process equipment can also be managed.
APC project managers routinely work across industries such as Pharmaceutical, Medical Devices, Blood and Tissue Laboratories, Radio Pharmacies.
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.
Validation/Qualification
Validation and Qualification is a key APC service, we are competent in Facilities and Utilities, Process Equipment, Cleaning and Computer System Validation, in accordance with international regulatory standards.
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.