Talking Point: Following transit and storage rules
pharmafile | March 12, 2010 | Feature | Manufacturing and Production |Â Â NYK Logistics, Talking Point, logistics, supply chain, talking logisticsÂ
Most people involved in pharmaceuticals will be aware of the strict procedures that must be employed for product manufacture (Good Manufacturing Practice, GMP) and the release process by the qualified person before product can go on sale.
You may be less familiar with the rules covering transit and storage. The supply chain can be complex as a significant number of stages take place before your product finally reaches the patient.
An example would be: from plant – maybe outside the EC, through packaging house, to your UK warehouse (internal or outsourced) – and onto the wholesaler and then the retail pharmacy/hospital customer, before it ever reaches the end patient.
All these transport and storage stages are covered under GDP (Good Distribution Practice) rules – contained in the ‘Orange Book’ – the bible for pharma logistics professionals.
The MHRA are the body who produce and police these guidelines for the UK. Each company will have a responsible person (RP) who must ensure compliance with these rules.
The RP is thus responsible for ensuring Product Integrity (correct storage/transit temperate, cleanliness), security of product as well as full batch/expiry date control and ability to recall product throughout your supply chain.
The Orange Book also gives guidance on returns policy i.e., what is acceptable to be returned to ‘free for sale’ stock and what returns must be destroyed.
This will depend on factors such as how long has the product been with the returning customer, are they a licenced premises and are there temperature records.
It was due to alignment with GDP guidelines that the provision of samples by representatives to healthcare professionals has been revised.
The questions asked were:
• Could you fully track, by batch number, where the product was?
• Could you confirm that the product had been stored at the appropriate temperature and not exposed to extremes of heat or cold?
In light of these questions, the ‘sampling’ policy has been reviewed.
A look at the MHRA website has highlighted a couple of recent topics relating to supply chain:
1. The risk of parallel exporting of product from the UK leading to shortage of supply
Guidance helping pharmaceutical manufacturers and distributors to meet their obligations regarding the supply of medicines was jointly published recently by nine organisations including the MHRA.
The current economic climate has resulted in an increase of some branded medicines being exported from the UK to other EU countries for profit.
This ‘parallel exporting’ of UK medicines is legal and in line with European trade laws.
However, this practice has the potential to contribute to shortages of medicines in the UK market, which could have an impact on patients and the level of care they receive.
The new guidance aims to reduce future problems with the export of medicines for profit by setting out the key legal and ethical obligations for manufacturers, wholesalers, NHS Trusts, registered pharmacies and dispensing doctors in relation to the supply and trading of medicines. The advice was developed jointly by various industry bodies representing the different parts of the medicine supply chain, including the MHRA and the ABPI (Association of the British Pharmaceutical Industry).
This guidance is relevant to marketing authorisation holders: manufacturers, wholesalers, dispensing doctors, registered pharmacies and NHS Trusts.
2. Risk of counterfeit products entering the UK supply chain
The World Health Organisation estimates that 10% of all medicines available could be counterfeit. But is it a risk in the UK?
Well, these stats from the MHRA website indicate that we cannot be too careful.
There have been nine recalls of counterfeit medicines in the UK in the past three years, which had reached pharmacy and patient levels.
A further five cases were discovered at wholesaler level before they reached the market.
Counterfeit medicines available in the UK originally focused upon ‘lifestyle medicines’ – including erectile dysfunction and weight loss medicines.
Counterfeiters are now also focusing on ‘lifesaving medicines’ – including cancer and heart medicines.
No fatalities have been attributed to counterfeit medicine in the UK, although numerous fatalities have occurred around the world.
Counterfeit medicines found in the UK are frequently designed to deceive pharmacists and patients to believe that they are genuine – often only laboratory analysis reveals the counterfeit product.
Counterfeit medicines discovered in the UK typically contain a reduced amount of the active pharmaceutical ingredient, although the wrong ingredient or no ingredient at all have been found less frequently.
The MHRA produced an anti-counterfeiting Strategy in 2007 which is policed by ‘the enforcement group’ at the MHRA which comprises of an intelligence, investigations, prosecutions and support unit of 42 staff based in London, Welwyn Garden City and York.
To further strengthen our supply chain a consultation is underway on ‘measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines’.
This is looking at areas such as:
• Fit and proper person guidance for wholesale dealers
• Introducing a code of practice for RPs – including due diligence requirement
• Storage and transit of medicines
• Role of retail and hospital pharmacies
The MHRA website covers a great deal more but is an excellent starting point for any questions from reporting a possible counterfeit product, to checking on licence approvals to reading about the latest swine flu advice. Or of course ask your own RP.
Website: www.nyklogistics.com
Contact: Richard Shore (richard.shore@uk.nyklogistics.com)
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