Standard Operating Procedures for Controlled Environments
Standard Operating Procedures (SOPs), or work instructions, are the foundation of quality management systems across industries. They provide consistent, detailed instructions for operations, covering materials, methods, equipment maintenance, and administrative tasks. Clear SOPs ensure compliance, uniformity, and high-quality standards, creating a unified company knowledge base and consistent corporate culture.
The FDA Code of Federal Regulations (CFR) mandates written SOPs and document controls for all life science operations. Written SOPs demonstrate compliance with quality, cleanroom, industry standards, health, safety, environmental, and manufacturing regulations.
This technical series covers following chapters:
- Introduction to Writing Internal SOPs for Controlled Environments,
- Optimizing Cleanroom Operations: SOPs for Gowning Protocols,
- SOPs for Cleanroom Operator Requirements and Training,
- SOPs for Facility Maintenance, Cleaning, and Sanitization,
- SOPs for Critical Cleaning.
