GMP, Quality and Quality Systems

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

APC has specialist knowledge in quality systems covering quality assurance, production, facilities and equipment, laboratory controls, materials, packaging and labelling.

Our Quality services include, quality system implementation/gap analysis, validation master plan, traceability matrices, qualification and validation of facilities, equipment and systems, quality system documentation, deviation management, corrective and preventative action (CAPA), sampling, recall systems, quality audit and before, during and post-certification audit guidance.

APC can advise on Good Distribution Practices (GDP) and Good Wholesaling Practices (GWP).

APC can develop a Quality Management System (QMS) tailored for your business. Our consultants can carry out a gap analysis on your QMS and provide remediation advice or prepare/revise QMS documentation.

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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 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.