Every FDA-regulated company should have these 10 standard operating procedures in place:
- Visitor & FDA Inspection policies and procedures
- SOP on SOPs
- Change control
- Quality unit authorities and responsibilities
- Internal audits
- Personnel health, disease control, qualifications and GMP training
- Product review, approval, release or rejection
- Vendor selection and qualification
- Sample storage and retention
- Customer complaints and product recall procedures
This list is not all-inclusive and the actual number of SOPs a company may develop and establish to address the above issues will be dependent upon company philosophies and complexity of operations. This list is reflective of those SOPs that will define the company’s management philosophy and policies related to these issues, and also addresses how certain functions or activities will be performed to ensure essential tasks are performed correctly, consistently and in conformance with internally approved procedures. The list does not include operational SOPs, which are dependent upon the actual functions and operations conducted by individual companies within specific facilities.
Additionally, for the purposes of NPA GMP certification, where NPA’s GMP standards state that there shall be written procedures—it must be taken as a mandatory requirement to establish one or more SOPs that address that particular GMP requirement.
