GMP Consulting and Engineering

Our GMP services include feasibility study, site master planning, facility and equipment design, procurement, facility construction budgeting, project management, cost management, engineering and services design, tendering, facility pre-audit, guidance before, during and post TGA facility audit, qualification and validation.

APC provides GMP/GEP consultancy and design services for cleanrooms, laboratories including QC laboratories (chemical and/or microbiological, containment (PC1, PC2, PC3, OGTR), controlled temperature warehouses for the pharmaceutical and allied industries.

APC offers consulting, design and engineering services. From site master and concept planning phase through detailed design, tender, procurement, support during construction and commissioning, to completion, handover and to supporting client operations to GMP/GxP principles within a quality system framework.

APC can tailor their services to meet your company and project objectives.

Services offered

  • Detailed Architectural Layout and Design
  • Utilities Design
  • Mechanical (including HVAL) and Electrical Design
  • Building Management (BMS) and Environmental Monitoring (EMS) Design.
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GMP, Quality and Quality Systems

APC can provide guidance with compliance to regulatory requirements such as FDA, PIC/s, TGA, ISO9001 and ISO13485.


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.

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.


APC can provide training covering PIC/S, EU, UK & FDA GMP Compliance. Training can be delivered on site or virtually.

Contracting Staff

Qualified staff ready to assist you with all aspects of quality and regulatory matters.