What is Quarantine in Good Distribution Practice?

‘Quarantine’ in Good Distribution Practice

Quarantine is a term that is often used in the context of public health, but it also has a specific meaning in the pharmaceutical industry.

According to the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use, it’s “…the status of starting or intermediate materials, or packaging materials, or finished products, isolated physically or by other effective means whilst awaiting a decision on their release or rejection”. In other words, it is a way of separating and controlling the materials or products that are not yet approved for distribution.

Why is Quarantine Important?

Quarantine is an essential part of the quality assurance system that applies to the distribution of medicines. It helps to ensure that only the materials or products that meet the required specifications and standards are released for sale or supply. It also helps to prevent the contamination, deterioration, adulteration, theft, and diversion of medicines.
It is especially important for temperature-sensitive products, such as vaccines and biologics, that need to be stored and transported under specific conditions to maintain their quality and efficacy: A deviation in this area means that the products must be quarantined for assessment by the RP.

How is Quarantine Implemented?

Quarantine is implemented by following the principles and guidelines of Good Distribution Practice (GDP), which is a set of standards that aim to ensure the quality and integrity of medicines during the distribution process. 

According to the GDP guidelines, quarantine should be applied to:

• Starting materials, packaging materials, and finished products on receipt from a supplier until their quality has been judged satisfactory.
• Rejected materials and products until a final decision has been taken on their fate.
• Returned products until a decision has been taken on their suitability for resale.

The GDP guidelines also specify that:

• Quarantined materials and products should be stored in separate areas that are clearly marked and access-restricted.
• They should be clearly identified with labels indicating their status and any special storage conditions.
• They should be released or rejected by authorised personnel following a documented procedure.
• Records of quarantine, release, and rejection should be maintained and traceable.

What are the Challenges and Best Practices?

Quarantine can pose some challenges for the organisations involved in the distribution of medicines, such as manufacturer licence holders, wholesale dealer licence holders, blood establishment authorisation holders, and non-UK sites employed by UK marketing authorisation holders. This is particularly the case for any shipments over long international distances. These organisations are required to obtain a licence or authorisation from the relevant authority and to undergo periodic inspections to check their compliance with GDP.

 

Some of the common challenges faced by these organisations are:

• Managing the storage space and capacity for quarantined materials and products.
• Ensuring the security and integrity of said materials and products.
• Monitoring the temperature and humidity conditions of quarantined materials and products.
• Handling the complaints, recalls, and returns of quarantined materials and products.

To overcome these challenges, some of the best practices recommended by experts are:

• Designing and maintaining adequate premises and equipment for quarantine operations.
• Implementing a robust quality management system that covers all aspects of the operations.
• Training and qualifying the personnel involved.
• Establishing clear roles and responsibilities for the operations.
• Developing and following standard operating procedures for the operations.
• Performing regular audits and self-inspections to assess and improve quarantine operations.

It is a regulatory requirement that you and your staff at all levels throughout the company receive GDP Guidelines training, before engaging the tasks and procedures involved within the registered and licensed premises.

Paradigm Shift Consulting Ltd offer a comprehensive range of courses designed to address all possible aspects of GDP operations. We run an online GDP Webinar for RPs and Management every month, with a thorough training schedule covering all 10 chapters of the EU guidelines complete with vivid examples of how things can go wrong and of course, the topic of Quarantine and what you must do to remain within compliance.

If you wish to know more, call us for a free 5 minute consultation, or you can use the contact form below. Alternatively, email us at info@gdptraining.co.uk if your requirements or issues are more complex.

A selection of useful links to associated subjects are shown below.

Online GDP Webinar for RPs and Management

Non-Conformance and Deviation Management

The Legal Supply Chain: Protecting the Patients

Why Does GDP Matter?

EU GDP Guidelines (2013/C 343/01)  Chapter 6