SOPs Standard Operating Procedures are typical for all GMP operations. Depending on the size of the operation, the number of such procedures is often in the hundreds with a rising trend. However: the findings in official inspections not only apply to missing or incomplete SOPs. A lack of transparency, an unmanageable flood of documents, is also a deficiency that appears in official reports. Putting GMP into practice means: doing what is described in each SOP. Therefore it demands a clear overview and manageability of the overall system.
Process versus Paper
SOPs ensure the reliable execution of standard processes. They help prevent mistakes, avoid the loss of knowledge and make starting out easier for new employees. SOPs must be clear, comprehensible, short, concise and yet precise. The process rather than the paper is important and takes centre stage. That is why gempex experts usually spend time on a process analysis, conduct interviews with stakeholders, and record and structure the process before preparing SOPs. Only then is this knowledge put on paper, packaged in comprehensible sentences and presented in the required form. This results in SOPs that actually represent the ideal process and support it day to day.
Templates – the Basis for Specific SOP Design
Numerous SOP templates are available over the Internet at low cost. Copy, paste, some minor modifications, apply a signature and you are done!? Better not! Authorities note a finding when they identify the copy/paste version, the non-specific document. Describing what actually takes place in the operation is essential. Here proven templates form the foundation, serving as a checklist, providing a structure, saving time and reducing costs. The expert work as such however lies in the process analysis and specific design of the final SOP.
Too Much of a Good Thing – SOP System Optimisation
Setting up SOP systems and writing SOPs is a central service. More and more often however, projects focus on optimising the SOP system since it grows over time, is gradually amended and sometimes gets out of hand. The overview is lost. What is missing, what can be eliminated? Where can content for similar topics be combined, duplication be avoided, and the system be made more flexible through proper referencing? These are increasingly challenging questions today. When the system is properly optimised, putting GMP into practice and acting according to the SOPs is made noticeably easier and more efficient.
Outsourcing – External SOP Maintenance
Preparing SOPs is one demanding task while maintaining them, keeping them current, distributing, retracting and archiving them is another. At least one person is required to look after all of this – regardless of how big a company is. This can overtax the resources of individual departments or smaller companies, making outsourcing these tasks a reasonable, economical solution. gempex looks after the professional maintenance, administration and distribution of SOPs, makes them available centrally using electronic platforms and ensures they are kept current in regards to the latest regulatory changes. As an external GMP office.
- an efficient, streamlined SOP system designed for easy maintenance
- benefit from experience that helps avoid small mistakes with possibly major consequences
- professional assistance with speedy implementation
- specific SOP design through a preceding process analysis
- time and cost efficiency through access to proven templates that provide structure
- reliable, fast optimisation of systems developed over time
- perspective of external experts
- outsourcing to ease the burden and relieve the strain on resources