Tabriz Consulting Pharmaceutical QA Consultants

Established in 2004, Tabriz Consulting are pharmaceutical QA consultants serving companies within the pharmaceutical and biotechnology supply chains, from suppliers of APIs, excipients and packaging materials, to primary and secondary manufacturers and those storing or distributing pharmaceutical cold chain and temperate products.

We provide GMP, GDP and validation training, QP services, interim QA management, temperature mapping, QMS development, and GMP and GDP auditing via a team of acknowledged experts in:

  • Supplier assurance
  • Validation
  • GMP / GDP regulatory compliance
  • Product transfer
  • Site closure
  • Pharmaceutical cold chain distribution

GMP, GDP and validation training

Our consultants deliver GMP, GDP and validation training at pharmaceutical QA conferences and seminars in Europe and the USA.

We can also deliver cost-effective on-site GMP, GDP and validation training on a comprehensive range of subject areas. Our highly interactive "Insight" training courses are led by pharmaceutical QA consultants who speak regularly on the international conference circuit. They are, however, tailored to the specific needs of the client and delivered at their own premises.

Our "Insight" client base includes multinational pharmaceutical, biotech manufacturers and pharma-logistics service providers as well as smaller local manufacturers of cold chain packaging materials.

QP services and interim QA management

Our consultants are available to provide QP services and QA management on a long-term or short-term contract basis for secondary pharmaceutical manufacturing and APIs. We can provide consultants to support:

  • Product transfer
  • Outsourcing to contract manufacturers
  • Pharmaceutical cold chain distribution
  • GMP, GDP and validation

Our consultants are currently providing QP services and interim QA management for companies in the UK, the Netherlands and the Republic of Ireland.

Temperature mapping

In the fiscal year 2005, 43% of all critical and major deficiencies recorded by MHRA’s GDP inspectors were in relation to the control and monitoring of storage and transportation temperatures; temperature mapping is a key tool.

Our temperature mapping service not only accurately tracks how conditions change within a storage area or stability incubator but also includes expert analysis and action planning.

Temperature mapping and reporting gives our customers confidence that their products and / or those of their clients are stored at the specified conditions as well as ensuring that they pass MHRA / IMB / FDA inspections.

QMS development

Our experienced pharmaceutical QA consultants can help with QMS development by preparing, or advising on the preparation of, key documentation such as technical agreements and standard operating procedures. We can also advise on the design and use of batch record templates.

Whether you have a brand new or an established facility, and whether you require QMS development to support a manufacturer’s or wholesale dealer’s licence, we have the experience to guide you.

One of our most recent projects involved QMS development for a brand-new cold-storage facility and the provision of advice on their application for a wholesale dealer’s licence. The QMS was reviewed and approved by the MHRA during the site inspection.

GMP and GDP audits

Tabriz Consulting can provide a comprehensive and professional GMP and GDP audits service to identify areas for improvement. Our pharmaceutical QA consultants can work with your teams to generate realistic improvement plans, or perform due diligence audits on your behalf at potential suppliers and / or contractors. Our consultants are experienced in:

  • Good manufacturing practice (GMP)
  • Active pharmaceutical ingredients (API)
  • Good clinical practice (GCP)
  • Good distribution practice (GDP)
  • Supplier assurance
  • Pharmaceutical and cold chain distribution

We can also offer GMP and GDP audits to support your site’s preparation for GMP, GDP and PAI inspections by MHRA and EC inspectors and the US F&DA.

Our experienced pharmaceutical QA consultants have conducted pre-FDA audits as well as audits of clinical trials manufacturing facilities, pharma manufacturing facilities, contract laboratories and warehouses in the UK, Europe and Canada.

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Press Release

Safe, Secure Storage and Transportation for Medicinal Products: What Do the Guidelines Mean in Practice?

In a two–day education programme called GMP in Storage, Distribution and the Cold Chain, our principal pharmaceutical quality consultant, Afshin Hosseiny, completes a distinguished panel of expert speakers who will share their knowledge and experience of GMP requirements and current developments

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Tabriz Consulting Ltd

9 Hazlemere Rd

Bucks

Penn

HP10 8AD

Other

United Kingdom

+44 1494 818159 +44 5601 169209 www.tabrizconsulting.co.uk

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Press Release

3 June 2009

In a two–day education programme called GMP in Storage, Distribution and the Cold Chain, our principal pharmaceutical quality consultant, Afshin Hosseiny, completes a distinguished panel of expert speakers who will share their knowledge and experience of GMP requirements and current developments

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28 May 2009

Tabriz Consulting's principal pharmaceutical quality consultant, Afshin Hosseiny, will once again share his experience and insight into the world of the qualified person at the European QP Association's forthcoming QP Forum. The Forum is designed by QPs for QPs and is fast becoming a majo

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12 March 2009

Tabriz Consulting’s principal pharmaceutical quality consultant, Dr Afshin Hosseiny, has recently returned from a visit to a US-based manufacturer of microbicide delivery systems. As part of preparation for phase three clinical trials manufacture, our client needs to validate their facilities and

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Regional Offices

Tabriz Consulting Ltd

9 Hazlemere Rd

Bucks

Penn

HP10 8AD

Other

United Kingdom

+44 1494 818159 +44 5601 169209 www.tabrizconsulting.co.uk

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