What are the requirements for SOP
What is an SOP?
The term Standard Operating Procedure (SOP or standard operating instructions) is understood to mean a standardized procedure for processes in critical areas of the pharmaceutical industry, in laboratories, the aviation industry or, for example, the military. All external and internal circumstances are included here. This documentation is intended for those areas that are usually not described in sufficient detail in test reports or test plans (e.g. according to GLP or ISO / IEC 17025).
In practice, an SOP has to be assigned to the work instructions. SOPs are used for the official approval of products or services that have an impact on the environment, health and safety. Failure to comply with the defined processes can result in significant sanctions by the authorizing authorities and are therefore to be classified even more strongly as work instructions.
Structure and structure of SOPs
SOPs must describe the respective work processes in as much detail as possible so that the user has as little room for interpretation as possible.
Typical formal features of an SOP:
- The title page with:
- Code of the SOP or version number
- Date of approval
- Validity date
- Name of the creator, reviewer and approver
- Page number and total number of pages
2. Table of contents (depending on the scope of the SOP)
3. Description of the workflow
4. Associated samples for quality control, if applicable
This is used for clear tracing and a compliant revision. This data can be placed very well in the header and footer of the document, for example.
How is an SOP managed?
- Creation of the SOP with documentation of the process (usually by those employees who are familiar with the work process to be described)
- Review of the SOP by a second person with signature and taking into account the test criteria used
- Approval by the person in charge of the management
- Distribution of the approved revision to the recipients and, if necessary, training of the persons concerned
When checking and approving, the following is observed:
- Is the content displayed correctly?
- Is the content described completely and without gaps?
- Have the formulations been chosen to be understandable?
- Are formal guidelines met?
What is the SOP for?
- Standard-compliant documentation of work processes within the organization
- Ensuring that every employee has the information relevant to their work available in a suitable form at all times at the relevant workplace
- Easier induction and training of employees
- Avoidance of recurring errors in the workflow
- Compliance with production requirements or with guidelines that affect the environment or compliance or similar.
Typical mistakes to avoid:
- Current version was not distributed to all relevant recipients
- Outdated versions in circulation
- Unstructured, ambiguous formulations (SOPs that are too detailed and extensive can also be unsuitable for everyday work)
- Too general description of the relevant workflow
- Description corresponds to the ideal state instead of the real occurrences
- Failure to adhere to formalities and structures
- No practical relevance of the SOPs (lack of acceptance etc.)
Example: For which areas should SOPs exist (according to GLP)?
- Test and reference items
- Equipment, materials and reagents
- Record keeping, reporting, retention and retrieval
- Test systems
- Quality assurance procedures
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