SOP Development for Efficient Cold Chain Management

Create Standard Operating Procedures (SOPs) to document cold chain operations, and assure compliance to regulatory requirements and product quality standards

SOP Development (Standard Operating Procedures) for temperature controlled logistics A major aspect of an efficient quality management system is the introduction and effective use of SOPs. Simply defined, a Standard Operating Procedure (SOP) is a comprehensive set of step-by-step instructions that are documented and followed by employees to carry out routine operations.

The purpose is to ensure the integrity and quality of your products by creating efficient uniform performance outputs. They also reduce communication gaps and related failures.

Certain temperature-sensitive pharmaceutical products, including vaccines, may lose their effectiveness if they are not stored within the recommended temperature range. It is, therefore, imperative to maintain the cold chain to ensure such products are transported and stored according to manufacturer’s recommended temperature range throughout shipment until the point of medication administration.

An SOP sets out effective command and control protocols, and detailed procedures for maintaining the cold chain for relevant pharmaceutical products and vaccines. It will also list steps to be taken in case of refrigerator failure, loss of power, or temperature fluctuations to mitigate financial or legal risks. Checklists for cold chain refrigerator audits may also be included.

Policy Statement: It summarizes the purpose of the SOP clearly and concisely, and describes the detailed policy it is intended to support.
Objective: It defines the scope of the SOP – what activities does it cover and where does it apply?
Responsibility: It assigns each task to the position of the person responsible for carrying out that task.
Relevant materials and equipment: It lists any associated SOPs, standard forms and other reference documents, and specific equipment requirements.
Procedure: It clearly describes the procedure as a series of steps. Diagrams and photographs are used where relevant.
Distribution: This records the distribution of the SOP documents and all revisions.

An SOP manual provides the information needed to perform a task correctly and consistently. It captures complete institutional knowledge to perform specific tasks and passes this on to new employees. Similar to other official documents, SOPs have to be well-managed and easily accessible to employees and kept up-to-date. Any previous versions of the manual should be withdrawn.

SOPs must be written by persons who fully understand the tasks being described, the context in which they are to be carried out and any risks associated with those tasks. In addition, they must be able to allocate the tasks to the correct personnel and ensure that the document is reviewed by colleagues and tested before it is released. A badly written and untested SOP is of no use, and may even be harmful.

As a certified ISO 9001 company, Mesa Labs has not only created SOPs for its own manufacturing processes but also offers SOP development, consultancy, and training services in end-to-end GMP and cold chain management. Having been in the industry for more than 20 years, Mesa Labs has built superior industry reputation for its technical excellence, domain expertise, and a large clientele worldwide.

We can provide pre-defined well-written model SOPs from our vast knowledge repository or help you develop your own context-specific, well-focused SOP document custom-written to your regulatory requirements by our skilled and experienced team.

Our team will review your requirements, conduct research and analysis, and then write the SOPs in line with your processes to ensure all regulatory compliance requirements are met.

Contact our services team for help in developing your standard operation procedures.