Third Party Audits GxP - services meets customer and regulatory requirements

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) January 9, 2012 -- comes compliance services (CCS) has upgraded its audit management services on a seperate domain: www.auditservicecenter.com

The new web site contains an entire overview of the audit management and related tools, which are totally integrated in the process work flows provided by CCS.

The Audit Service Center (ASC) is an independent provider of value-added regulatory quality and audit management services. Starting with the existing compliance programs of our clients we optimize such programs and manage quality audits of manufacturers of materials, products, components, and services providers, in GMP, GCP, GDP, GLP regulated industries such as pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements.

Our team of highly dedicated quality experts delivers to our clients actionable strategic decision systems, improved supply chain processes and inspection readiness. The Audit Service Center implements tested and proven strategies, tools and methods to cut costs and increase profitability of compliance and audit programs.

Our compliance projects ensure that supply chain requirements meet quality management support, be it for finding a second source of material or component supply, collaborating with suppliers on quality aspects, or investigating suitable outsourcing options. We create the “vendor to partner” dynamics required for improving products and reducing deficiencies.

Section 5.25 of the European GMP Guide requires starting materials to be purchased from approved suppliers and about whom the manufacturer has a particular and thorough knowledge.

An audit conducted by the manufacturing authorisation holder itself should be integral to the manufacturer's quality assurance system and subject to the basic GMP requirements i.e. conducted by properly qualified and trained staff, in accordance with approved procedures, should be properly documented and these aspects can be inspected as necessary by the Competent Authorities. If a third party is involved then the arrangements should be subject to Chapter 7 of the GMP Guide and there should be evidence that the contract giver has evaluated the contract acceptor with respect to the aspects described above. All parties involved should be aware that audit reports and other documentation relating to the audit will be made available for inspection by the competent authorities if requested. This should normally provide sufficient assurance that the results of an audit carried by the third party are credible thus waiving the need for an audit conducted by the manufacturing authorisation holder itself. However, it must also be satisfactorily demonstrated that there is no conflict of interest. Conflicts of interest could arise for example from:
1. A commercial relationship between the organisation performing the audit and the organisation being audited.
2. A personal conflict on the part of the auditor where he/she has been employed by the organisation being audited in the recent past (i.e. within the last 3 years) or has a financial interest in it.

This topic should also be addressed in the technical contractual arrangements and any measures taken by the contract giver should be documented e.g. signed undertakings by the auditors.

Similarly, the principles outlined above could be used to allow sharing of audit reports between different manufacturing authorisation holders using the same active substance supplier, provided the scope of the audits can be shown to be applicable to the active substances of mutual interest.

Visit now: www.auditservicecenter.com to get more information and news about audit and CAPA management, supplier chain optimization, shared audits, and other compliance service options.