Are there basic standard operating procedures (SOPs) that all companies should have in place?
Every FDA-regulated company should have these 10 standard operating procedures in place: 1) Visitor & FDA Inspection policies and procedures 2) SOP on SOPs 3) Change control 4) Quality unit authorities and responsibilities 5) Internal audits 6) Personnel health, disease control, qualifications and GMP training 7) Product review, approval, release or rejection 8) Vendor selection and qualification 9) Sample storage and retention 10) 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 proce
Related Questions
- May standard operating procedures (SOPs) or blanket protocols that cover a number of procedures be utilized in lieu of repeating descriptions of identical procedures in multiple protocols?
- Are there basic standard operating procedures (SOPs) that all companies should have in place?
- What are standard operating procedures (SOPs)?
