Audits and Inspections
How does your business benefit?
Auditing is a process that scrutinises an organisation’s products, processes, or systems. Besides its regulatory value, auditing and inspection provide opportunities to improve products, services, processes, and systems.
We see audits and inspections as an opportunity to provide you an independent perspective to promote continuous improvement, or as preparation for regulatory and other inspection-types.
We pride ourselves on providing rigorous audits and inspections in regulated and non-regulated industries regarding:
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Products and Services,
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Processes, and
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Systems (including quality management systems).
Komply can also conduct audits and inspections on behalf of third-parties, like certification bodies, or external audits for businesses in several regulated industries.
Industries we work with
Pharmaceutical
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Active Pharmaceutical Ingredients (API)
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Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables), steriles, and freeze-dried
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Prescription medicines, Over-the-Counter (OTC), complementary & herbals
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Biologicals
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Blood & Blood Components
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Drug and device combinations
Veterinary Medicine
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Active Pharmaceutical Ingredients (API)
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Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables, drenches, dips), steriles, and freeze-dried
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Biologicals
Food and Beverage
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Dairy
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Processed & ultra-processed foods
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Allergen management & control
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HACCP
Logistics
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Transportation
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Warehousing
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Distribution
In Vitro Diagnostic Device (IVD)
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Class I, II, III, IV (TGA – Australia)
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Class I, II, III (US FDA)
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ELISA
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Diagnostic disease screening
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Lateral flow
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Immune diagnostic
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Chip/capillary
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Capture systems
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Injectables
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Point of Care (POC) or self-testing
Medical Device
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Classes I, Is, Im, IIa, IIb, and III (TGA - Australia)
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Classes I, II, and III (US FDA)
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Lowest, low, moderate, and high risk (TGA – Australia)
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Simple & complex
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Disinfectants & sterilants
Cosmetics and Sunscreen
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Primary sunscreens
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Secondary sunscreens
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Listed therapeutics
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Registered therapeutics
Other
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Testing laboratories
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Building and construction (laboratories & cleanrooms)
Standards applied in our work
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PIC/S Guide to Good Manufacturing Practice for Medicinal Products
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US Code of Federal Regulations
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ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes
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ISO 14971:2019 – Medical devices – Application of risk management to medical devices
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ISO 9000 Standards Series (including ISO 9001 – Quality management systems – Requirements)
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Veterinary GMP codes
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HACCP, Food Standards Code, and Food Safety Systems (FSSC 22000)
What sets Komply apart?
Leveraging over 30 years’ experience in leading national and multinational biotechnology, contract manufacturing, and consulting organisations, we provide reliable and personalised service.
We believe consulting should be as educative as it is troubleshooting. We transfer knowledge, skills, and experience from consultant to client, and inspire organisational self-sufficiency. You will leave knowing you can tackle challenges without significant external help.
Our tailored, flexible, and client-centric approach means you can rest easy knowing your goals will always be met.
