GXP / GMP Consultancy

As well as offering training courses we also provide pharmaceutical GXP and GMP consultancy and auditing services. For this we only use leading industry specialists. Specialists who not only have a great deal of experience but also have practical skills and ability to get issues sorted. Our idea is that our consultants should be able to work with you and help you, rather than create even more work for you! We can help with the following areas within the pharmaceutical industry:

Auditing service

We perform supplier audits as well as internal audits against most recognised pharmaceutical standards. We use specialist sector-specific auditors as needed, including experience IT/ Computer System auditors.

Inspection preparation

We help get sites ready for Regulatory and Corporate inspections, including working with groups to get their own areas ready. We can also assist behind the scene during the inspection itself.

Inspection remediation

Not all audits go well, and we can help get sites that have had poor inspections back on their feet.

Qualified Person release

Many of our consultants are eligible to act as Qualified Persons (QPs), and so we can provide locum QP support when needed.

Recent projects have included:

Selecting possible new manufacturing site in Asia

5 sites in Malaysia were identified as possible manufacturing sites for a new medicinal product.
All were audited to GMP (to look for compliance), suitable technology transfer skills and the ability to supply product on time.
A short list was created and on-going partnership discussions continue.

Selecting possible supplier of an Active Pharmaceutical Ingredient

A number of potential sites in Asia were identified.
All were audited to API GMP.
A short list was created and business discussions continue.

Support for development of European QA Managers

A number of new QA Managers at Country Business Units (Affiliates) around Europe have been supported over the past 5 years.
Many were new to GMP.
Included audits of their offices and gap analysis against company requirements.
Followed by support and ongoing training and development.
QA Managers now have a much greater appreciation of the rules and regulations of EU GMP.

If you would like to find out more please send an email with your details and we will be in touch.

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

More details