International GMP Compliance Audits

Auditing. Just the word itself can instil a lot of fear in even the most hardened industry professionals! If you’ve got any compliance worries and want an independent check on the GMP ‘health’ of your facility, or have had an audit and don’t know where to begin remediation efforts, PharmOut can provide GMP Compliance auditing and remediation services to the level of:

  • Australian, Therapeutic Goods Administration (TGA), regulating medicines, medical devices, blood, tissues and chemicals in Australia
  • United States, Food and Drug Administration (FDA), regulating US Food and Drugs.
  • Europe, European Agency for the Evaluation of Medicinal Products (EMEA)

 

Our auditing services include:

21 CFR Part 11 / Annex 11 Compliance

We can provide auditing services to see if you are compliant with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) as outlined in the US Code of Federal Regulations (CFR) Part 11, or those documented in EU or PIC/S Annex 11.

Audit Findings and Responses

Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to address a few small issues. PharmOut can help prepare your GMP Audit Response.

Audits for Research Institutions

Not only do we provide audits to GMP international regulatory standards but we can also provide audits catered to research laboratories that fall under Good Clinical Practice and Good Laboratory Practice requirements.

Compliance Strategy Development

GMP compliance can be tricky. With so many regulations and interpretations from different regulatory bodies, it’s hard to know where to even begin and which of the rules, standards and guidelines apply! We can help you develop a GMP compliance roadmap to guide you on your way.

GMP Compliance Audits

If you have a regulatory audit coming up or just want a check on the current compliance status of your facility, make sure you are audit-ready by having a pre-audit performed by one of our experienced consultants.

Australian TGA Audits

At PharmOut we are fortunate to employ a number of  ex-Australian Therapeutic Goods Administration (TGA) inspectors as consultants. They are TGA experts and can help  you with obtaining regulatory approval from the TGA.

TGA Regulatory Affairs Services

We offer registration strategies and assistance with submissions for companies who wish to supply products to the Australian market but are unsure of the regulatory requirements.

Vendor Assurance/Supplier Audits

PharmOut can help you set up a GMP vendor management audit programme to assess the GMP compliance of suppliers.

If you would like us to help with compliance issues on your site, want to organise pre-audit or post-audit remediation programs, or just have some questions you want to ask, contact us here.

If you want to read more about regulatory matters and topics relating to PIC/S, the ICHFDATGAMHRA or EU and EMA, click on the relevant links.