Service
Quality Auditing
APC can provide the following auditing services,
- Remediation audits
- Mock audits
- 21 CFR Part 11 gap analysis
- ISO 13485 gap analysis
- GMP gap analysis
- Vendor Audits
- Supplier Audits
- Audit finding responses
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.
Audits can be carried out remotely, in person or as a hybrid as required.
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.
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.
Training
APC can provide training covering PIC/S, EU, UK & FDA GMP Compliance. Training can be delivered on site or virtually.