Cold Chain Management: A Critical Point for Temperature Sensitive Drugs in Clinical Trials
Life Sciences
The burden of developing diseases, the increase in the ageing population and the reduction of the pipeline of products of the oldest often prescription drugs, are urging the pharmaceutical and biotechnological industries to dispose of new chemicals and to market new medicines at an increasing rate of.
These products cannot be placed on the market, without appropriate clinical trials, which are conducted on a global scale, with different populations and in some cases in locations with less than optimal or developing logistics infrastructure.
In the clinical supply chain, each individual department is critical to the integrity of the, efficacy and safety of the medicinal products under testing, from Active Pharmaceutical Substances (Api) and the manufacture of medicines up to and including delivery to the patient. This is particularly true for temperature-sensitive and time-sensitive medicines used in clinical trials.
Without the necessary compliance during production, storage and distribution of these medicines, patients are at risk of getting unsafe or spoiled products. Extra, clinical trials could be delayed, end up with inconsistent results or even fail
It is at this point that cold chain management assumes its role, as proper control is required, to ensure current standards of excellent quality. Without them, The impact of temperature limit violations, will be disastrous for the integrity of temperature-sensitive products.
Learn more about how Sensitech services® ColdStream® Quality and Compliance and its products, provide solutions to the challenges of regulatory regulations and the supply chain.
Why proper cold chain management is vital
Optimal maintenance of the cold chain becomes increasingly important as companies face ever-increasing regulatory concerns, extensive development of bio-vaccines and increasing supply costs. The aim in each of these trends is to ensure maximum patient safety.
In the study done by SCORR Marketing and I'm not going Clinical Trials, respondents from different types of companies participating in clinical trials provided some information on the management of the cold chain. Here are some highlights:
- Almost half of them (49%) respondents pointed out that reliability is the leading influence on clinical decisions on the cold supply chain.
- Above the 65% stated that the trends in the regulations have a to very significant impact on the distribution of a cold chain. Extra, for more than 60% of respondents, reported that the development of organic products and vaccines is crucial to the. Above the 50% reported supply chain costs as an important factor in the.
- For better management, Temperature monitoring is the leading technology solution, finds the 63% of respondents to rely on it.
Best practices and protocols are key
For companies to meet the challenges of cold chain management, seek documented protocols and best practices that comply with Good Cold Chain Management Practices (GCCMP). This is how they support compliance with industry and government regulations. These practices are particularly important for cold chain management for temperature-sensitive drugs and clinical trials.
To ensure proper temperature management in trial treatments, recommended source is the of March 2015 directive, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (Annex 15: Qualification and Validation). This document describes the certification and validation authorities, which apply to establishments, equipment, the utilities and procedures used in the manufacture of medicinal products;. It can also, to be used as additional voluntary guidance for active substances.
There is increased regulatory pressure both for the conclusion of technical quality agreements with supply chain partners, as well as for the control of suppliers for continuous improvement. In the study mentioned above, The 57% of the companies surveyed outsourced cold chain management. in these cases best practice training may be required for appropriate storage, Handling and distribution.
EU guidelines outline a quality risk management approach and defined procedures to be applied throughout a medicine's lifecycle. Extra, provides information on what a quality risk management system should provide, such as justification of the scope and scope of qualifications and the validation covering the facilities, equipment, utilities and processes.
Transport is also a key area covered by the EU guidelines. Here are some details:
- Finished medicinal products, research drugs, the bulk product and the samples must be transported from the manufacturing site in accordance with the conditions laid down in the marketing authorisation., the approved label, the product specification file or as specified by the manufacturer.
- It is recognized that the certification of transportation can be difficult due to the relevant variable factors. However, transport routes must be clearly defined. Seasonal and other variations should also be taken into account when certifying the transport.
- A risk assessment should be carried out to take into account the impact of the variables on the transfer process other than those conditions that are continuously controlled or monitored. This includes delays in transit, failure of monitoring devices, product sensitivity and other relevant factors.
- Due to the expected variable conditions during transportation, continuous monitoring and recording of any critical environmental conditions to which the product may be subjected must be performed.
Sensitech's Contribution
Sensitech Professional Services will compile a temperature-sensitive supply chain assessment / temperature-sensitive supply chain assessment and will evaluate, document internal and external practices as defined by the EU Directives. Each assessment is tailored to meet the needs and objectives of each client, to identify thermal compliance gaps and improvement opportunities. For example, An assessment may include the overall assessment of global supply chains in different seasons, or could be adapted to the assessment of a particular commercial stripe, product or other variable.
Another key step required by regulatory agencies is proper electronic record keeping. This is related to the fact that the majority of people surveyed above use temperature monitoring technology. This usually includes a secure and comprehensive data management system for viewing, storage, Time and temperature data recovery and analysis for temperature-sensitive shipments. The data management system must be designed and manufactured to comply with FDA guidelines 21 CFR Part 11 and the Annex 11 OF (Data management). Using this technology demonstrates control and provides companies with notifications that they may initiate investigations, which also need to be documented.
Source: Sensitech Inc., USA