Researchers publish ten step procedure for tackling temperature excursions

Chan
Posted: 09/21/2017

In the face of safeguarding sensitive products travelling through challenging regions, research has uncovered a step-by-step quality strategy quality to minimize the risk of temperature excursions

As specified in Good Distribution Practice Regulations (GDPs), every pharma product needs to be transported and stored in required conditions to preserve the medicine’s integrity. Temperature excursions jeopardize drug quality and stability.

According to Nirmal Kumar and Ajeya Jha of the Sikkim Manipal Institute of Technology in their recent study, “temperature excursions during receipt of raw materials, manufacturing of pharmaceutical products and distribution should be managed during [the] entire product life cycle with holistic approach.”

They recommend rolling in the following ten steps into Standard Operating Procedures of Quality Management Systems (QMS) when transporting medicines.

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1. Technical agreements

These should clarify the responsibilities of the manufacturer and the distributor in the event of environmental excursions during transport– i.e the notification process. Similar to working with any vendor, this agreement should be put in place before activities commence and come in the form of a legally binding contract. The product manufacturer should have these agreements with the supplier of the active pharmaceutical ingredients and the transporters, freight forwarders.

2. Access to data

All relevant supply chain stakeholders should have access to the database detailing the characteristics and requirements of the product in question. These characteristics would include the storage instructions and restrictions labeled on the packaging the medicine.

3. Quality Checklist

The QMS should include a checklist that qualifies the status of the following against GMP and GDP requirements:

  •  Manufacturing plant of choice
  •  Mode of transport and shipping containers
  •  Handling devices and the replenishing process
  •  Warehouse in loaded conditions
  •  Distribution centers
  •  Pharmacy

4. Reaction plan

The SOP should focus on points in the lane that are at high risk of temperature excursions.

This document should specify best practice measures regarding the investigation, handling and management of these breaches. All handlers should be made aware of this resource. 

5. Continuous monitoring

The authors note that: “Records related to temperature excursions and duration should be regularly reviewed and approved to ascertain whether an excursion may have occurred and a systematic investigation should be performed.”

 This approval process should be authorized, whether it is physically or virtually.  

6. Timely notification

Investigations into temperature excursions and their duration should be communicated as soon as possible to the responsible person or manufacturer as defined in the technical agreement.

7. Damage evaluation

In each case of a temperature excursion, a risk analysis should be conducted to assess the quality of the medicine.

The specimen complaint sample and a control sample should be compared via the validated analytical method. Tests should aim to examine the loss of assay and the degradation of purity.

8. Availability of stability data

Against each excursion, the medicine’s stability data should be accessible to verify if there has been an impact on product quality.  Handlers will need to refer to data from the product’s stability study conducted under accelerated conditions, in line with ICH guidelines, as well as freeze-thaw tests.

Freeze-thaw studies calculate the impact had on a medicine from storing it at extremely low and high temperatures (-20°C to +50°C) for up to 12 days. Various cycles will be used in accordance to the distribution lane at hand.

9. Trend spotting

Quality professionals should periodically review statistics relating to temperature excursions to look for trends. If a recurring trend appears then the related facilities should be requalified.

10.   Intervention

If a trend is spotted intervention measures should be made regarding the infrastructure of a lane to prevent temperature excursions from occurring. This may require the modification of storage or transportation modes using a risk management program.

 

Chan
Posted: 09/21/2017
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