The European Union’s GDP guidelines were updated on the 7th March 2013. Its requirements (Ref: 2013/C 68/01) come into force 6 months after this date and it applies to the movement of finished pharmaceutical products. You can download a copy here: GDP New. Like GMP Good Distribution Practice has a series of Chapters (10 in all) and these can be seen below. In this post we will highlight the main requirements of the new GDP guidelines, which are much more details than the previous version from 1994 (Ref: 94/C 63/03). For reference the old version of GDP is here – feel free to quickly look at this: GDP Old
Chapters of GDP
- Quality Management
- Premises & equipment
- Complaints, returns, suspected falsified medicinal products and medicinal product recalls
- Outsourced activities
- Self Inspection
- Specific provisions for brokers
1. Quality Management
In the chapter on Quality Management there is an increased emphasis on the quality system setting out in detail additional expectations on how the QMS should operate. This includes the requirements for having systems for Change Control, Corrective Action and Preventive Action, Management Review and Quality Risk Management.
In the chapter on personnel there is the need for an adequate number of competent personnel, organisational charts, job descriptions and initial and on-going staff training. Personnel should also be trained in GDP and hygiene. The roles and responsibilities of the Responsible Person (RP) are also defined and these are highlighted next. There is also the requirement that the RP should be continuously contactable.
The duties of the Responsible Person (RP) are also defined in Chapter 2. These include:
– Implementation and maintenance of the QMS.
– Management of activities and quality of records.
– Initial and continuous training of personnel.
– Coordinating any recall operations.
– Ensuring that customer complaints are dealt with.
– Ensuring that suppliers and customers are approved. Note that customers also need to be approved! This is rare for many normal organisations. Here it means that you only supply medicines to organisations who are authorised to receive them.
– Approving any subcontracted activities.
– Ensuring that self-inspections are performed.
– Keeping appropriate records of any delegated duties.
– Deciding on the final disposition of returned, rejected, recalled or falsified products.
– Approving any returns to saleable stock.
– Ensuring that any additional requirements imposed on certain products by national law are adhered to.
3. Premises & equipment
There should also be suitable premises and equipment. This includes clean, orderly, safe and secure storage of materials that will not negatively affect their quality. There is also the requirement for validation of equipment and computer systems as well as temperature mapping of storage areas and on-going monitoring. There also need to be adequate records of repair, maintenance and calibration activities for key equipment.
The chapter on documentation has many of the general principles that are also found in GMP. These include that they should be clear, understandable and free from errors. Documentation should be approved, signed and dated by appropriately authorised persons. They should be regularly reviewed and kept-up-to-date. Records should be completed at the time of action. Alterations made to entries in records should be signed and dated and the alteration should permit the reading of the original information. Note that there is no specific requirement that entries to paper-based records be made in ink. Documents should be retained for at least 5 years.
The chapter on operations see a detailed expansion of requirements. These includes the requirements to ensure that all suppliers and customers are legitimate and authorised (bona fide) to handle medicinal products and that appropriate due diligence has taken place. Storage conditions should be suitable for the items stored. There should be careful control of picking, supply, export and destruction of unwanted materials. There is also a new requirement for using stock that is First Expiry First Out (FEFO) rather than First In First Out (FIFO) so older stock is used first.
6. Complaints, returns, suspected falsified medicinal products and medicinal product recalls
There are no major changes to the requirements on complaints, returns, suspected falsified medicinal products and medicinal product recalls. The requirements include that complaints are recorded, a nominated person should deal with complaints and necessary follow-up action should occur. Returns need to be carefully controlled. The distributors must immediately inform the competent authority and the marketing authorisation holder of any medicinal products they identify as falsified or suspect to be falsified. Finally effective recall mechanisms need to be in–place.
7. Outsourced activities
With any outsourced activities a written contract between the contract giver and the contract acceptor should exist. This should establish and define the duties of each party.
8. Self Inspection
There is also a more detailed requirement for self-inspection within the new guide to GDP, and this follows the similar principles of self-inspection in GMP. In essence self-inspections should be conducted according to a programme, performed by independent personnel, be recorded, the results made available to management and followed by appropriate actions to deal with any issues seen.
There are many new additional requirements of the new guide to GDP when it comes to transportation. This follows lots of problems and concerns in this area. The requirements include that products should be shipped according to the labelled conditions and that excursions are reported. There are detailed requirements for shipping temperature sensitive items. Contracted transporters should be informed of storage conditions. Note that there is no mention of “ambient” or recording temperature during “ambient” transportation however there is a need for a documented risk assessment of delivery routes to identify when temperature control is needed. In all cases suitable and secure storage conditions are required. Finally there is the requirement to use dedicated vehicles where possible.
10. Specific provisions for brokers
The final chapter of GDP covers specific provisions for brokers. This is a totally new addition to GDP and requires that suitable systems are in place for individuals or organisations involved in the sale or purchase of medicinal products.
This is a simplified overview of the new GDP guide. It has many more detailed requirements than its predecessor. You should read the full document however to gain your own understanding. I hope that this post is useful. If you need any help with any GMP / GDP or Quality related training and consultancy – please get in touch at email@example.com or visit our website.
Feel free to add any comments below.
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 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.
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