manufacture and distribution of medicine
Key Forthcoming Changes to the EU GDP Commission Guidelines – by Sanjay Nadarajah
(Sanjay Nadarajah’s article was originally published in the RQA’s Quasar magazine, January 2013 edition)
First published in the Official Journal of the EU in 1994, the Guidelines laid down in Article 84 of Directive 2001/83/EG on Good Distribution Practice (GDP) of Medicinal Products for Human and Veterinary Use (Document 94/C 63/03) have remained unchanged. The 1994 Guidelines do not reflect recent radical developments in the practice of storage and distribution. Vast changes over the last decade have overhauled the Pharmaceutical industry, prompting the introduction of Directive 2011/62/EU on Falsified Medicines (which provides Writing guidelines on GDP). Revising the outdated 1994 GDP Guidelines was now deemed a necessity.
On 15 July 2011, cheap MLB jerseys the EU Commission published a draft guideline on Good Distribution Practice on its website, for public consultation. From the responses reviewed (made public on 3 February 2012) the Draft paper had clearly stirred debate. Whilst the increased clarity and detail was welcomed, some proposed requirements such as auditing and approving all Distribution Hubs were seen as unrealistic, with more practical, risk-based solutions being offered. The European Medicines Agency’s GMP/GDP Inspectors Working Group is currently reviewing and evaluating the results of the public consultation.
Both the current and proposed guidance touch on: Personnel, Documentation, Premises and Equipment, Complaints, Returns, Recalls and Falsified Medicines and Self-Inspections. However, the proposed revised Guidelines are far more extensive, elaborating on GDP controls to be applied during the storage and distribution of Pharmaceutical products. Unlike its predecessor, the new guidance is organised into dedicated chapters.
Additional chapters introduced cover Quality Management Systems (QMS), Operations, Contract Operations, Transportation and Specific Provisions for Brokers.
The gap between Good Manufacturing Practice (GMP) expectations and that of GDP is slowly being eroded.
Is a detailed guidance really necessary?
Foremost, a detailed guidance provides the wholesale NBA jerseys industry with greater clarity on regulatory expectations; and helps to minimise any scope for misinterpretation. The primary focus is to ensure that the product received by the patient is of the right Quality, Safety and Efficacy.
Second, the increasingly complex and changing landscape of the Pharmaceutical Industry supply chain requires structured, detailed and practical guidance. Products going off-patent, have sparked a sharp increase in the Generics market that relies upon high efficiency at low cost. The common solution has been to outsource manufacture and distribution. The result: greater numbers of more specialised players now comprise the supply chain.
Involving several different contract sites in the sourcing of raw materials, manufacture, packing, storage and transportation of just one product rears its own problems. Poor communication and improper handling of medicines could well become the norm for a convoluted supply chain, resulting in inefficiency and poor Product Quality. There is heightened risk of Ligula counterfeit product or falsified medicines entering the legitimate supply chain.
Maintaining greater controls over the cheap MLB jerseys entire supply chain is now a necessity. The question lies in what controls, and when these should be applied. Here, the guidance looks to the tightly regulated Manufacturing operations for inspiration. GMP related controls for example: – deviation reporting, change control, corrective and preventative actions and risk management – are now being applied to GDP operations.
A risk based approach
Working to a risk-based approach requires understanding of the Product, its entire supply chain, and provides focus. Risk assessments have long since been used within GMP. With the complicated supply chain, rise in product recalls and implementation of the Falsified Medicines Directive, a Risk Management Programme is all but imperative.
The Risk Management programme would consist of the following steps: assessing any risk to product or process; controlling and mitigating the risk; communication to all parties concerned; and a final review of the risk management process itself. Any risk evaluation must be based on factual data from the product and process. The greater the risk, the more information required.
Implementing a risk management programme is a good starting point for meeting new Guideline expectations. Analysing feedback from the public consultation revealed a general consensus that some proposed controls were excessive and unrealistic.
Consultation feedback: four areas of concern
Section 9.12 – “where medicinal products are held on the premises of a hub for longer than 24 hours these will be deemed to be acting as a storage site and required to obtain a wholesale distribution authorisation”
Concerns were raised that many hubs currently used do store medicinal product for greater than 24 hours – over weekends, for example. If mandatory licensing is introduced, storing medicinal products may not be viable from a hub cost-benefit perspective.
An alternative would be for the product licence holder to perform a risk assessment. Appropriate controls are specified to ensure appropriate handling of product, in the event a hub is used.
Section 9.13 – “Where hubs are utilised these should be audited and approved prior to their use.”
Auditing all hubs was considered unrealistic due to time, cost and resource constraints.
The product licence holder could instead issue audit questionnaires. Another option to explore would be to generate a public repository where pharmaceutical companies access a database of GDP audits performed on hubs.
Section 9.19 – “Validated temperature control systems should be used during transportation of cold chain and ambient storage products”. Feedback recommended that the guidelines allow the product licence holder Type to risk assess transportation channels for the specific product and its labelling, ensuring that appropriate temperature controls are applied.
Section 6.9 ii) – “Products returned from customers that do not hold a wholesale dealer licence should only be returned to saleable stock if they were returned within five days of original dispatch.” Again, a risk-based approach Beheer was suggested here. Information gathered on the returned product is used to make a risk assessment, and a decision made: whether or not to return to sale. This renders the five-day defined timeline unnecessary.
The updated EU GDP Guidelines are a welcome, timely revision that makes legislative guidance relevant and useful. – They provide much needed clarity to the rapidly changing Pharmaceutical industry. However over-legislating can hamper Banque the Industry’s ability to make continual improvements to meet future challenges. A risk-based approach coupled with clear guidance may be the way forward.
Sanjay Nadarajah is the founding partner and Quality Director at inglasia pharma solutions (IPS). IPS promotes Pharmaceutical Quality standards globally, through training courses, e-learning and consultancy services. Spanning fifteen years, Sanjay began his career as a laboratory Quality analyst, gaining a solid grounding in GMP. Having carved a pioneering path, he went on to head a European Quality function; most recently served as Corporate Global Auditor, specialising in GDP Provisions.