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GDP Audit Services2017-12-08T17:38:57+00:00

GDP Audit Services

The concept of Self-inpections has long been implemented within GMP regulated industries and is derived from ISO 9001 Quality Management Systems Standard (3).

Self Inspections were introduced into the latest the EU Good Distribution Guide in 2013 and are required to be performed by individuals responsible for the implementation of the Quality System.

Chapter 8 of the EU Good Distribution Practice Guide states:

Self-inspections should be conducted in order to monitor imple­mentation and compliance with GDP principles and to propose necessary corrective measures.

The lack of Self-inspection is one of the most common GDP deficiencies reported by the MHRA.

It should be noted that External Audits differ from Self-inspections as the former must be performed by an independent auditor who must not have any responsibility for the process or system audited.

Aims of a Self -inspection

The aim of Self-inspections is to remain compliant by:

  • Evaluating the organisations operations against the GDP guidelines
  • Recommending corrective actions, and
  • Setting action plans to ensure corrective actions are completed

Self-inspections should be performed by the Responsible Person (RP) at least every six months or at minimum once a year.

GDP Audit Services

As an additional service, we also offer the following suite of External GDP Audit Services:

All our External Audits are designed to assist clients to ensure they meet the required quality standards.

Our External Audits examine and evaluate internal controls in your Quality System, identify organisational risks and suggest areas of improvement.

We believe in offering a impartial service and therefore do not participate in performing GDP Audit Services on any  organisation with whom:

  • We have had a commercial relationship
  • Any of our auditors has had a personal conflict
  • Has been been employed in the recent past (within the last three years) or
  • Has a financial interest in it

Awaiting Inspection? Are you ready?

We know how stressful it can be waiting for the inspection date to arrive.

Whether its your first inspection or one of many you have been through, the feeling of unpreparedness always seems to linger around these formal occasions.

Instead of panicking and having a last minute dash to get your records up to speed, why not let is take the strain?

Our Inspection Preparation audit is designed to identify the gaps in your Quality System to enable appropriate action to be taken.

After all, ‘forewarned is forearmed”.

If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation  please contact our office and send us your request, or schedule a free initial telephone consultation.

Revoked or Suspended Licence? Don’t panic, get in touch

Sometimes, a lapse in organisational competence or an unexpected event can leave a company distracted from its compliance obligations. For the unlucky few, this can be disastrous as it can lead to financial meltdown.

Identification of a number of Critical Failures by the MHRA can result in your Wholesale Dealers Licence being revoked or suspended.

All trading suddenly comes to a halt as your business partners lose confidence in your organisation.

If you are faced with such a situation, help is at hand through our Inspection Remediation service.

If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.

Pharma Experts is a Cogent Assured Provider

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Upcoming Events

Tue 18

GDP Annual Refresher Training

December 18 @ 9:00 am - 5:00 pm