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We offer GCP/GMP/GLP SOPs singly or grouped, for U.S. FDA-regulated industries: Pharmaceutical, Biotechnology, Medical Device, and Quality Manuals.
Our Current Good Manufacturing Practices (CGMP) / Quality System Regulation Standard Operating Procedures (SOPs) provide basic templates for U.S. FDA-regulated industries including Pharmaceutical, Biotechnology, Medical Device and Diagnostics. Our templates can be used 'as-is' or customized by your personnel to meet your company's specialized needs. View sample lists.
SOPs are available for:
- Production and Process Control
- Adverse Event Report
- Document Control
- Training
- Quality Manuals (GMP, ISO 13485, ISO 9001)
- Validation templates -- IQ, OQ, PQ, software
- Risk Management File templates (ISO 14971:2007)
- Other
*All SOPs are disgned to meet U.S. FDA requirements under 21 CFR Parts 11, 210-211, 820, and ISO 9001, 13485, and 14971.
Need a quote? E-mail us at SOPs@Safis-Solutions.com or by phone at (317) 777-6200.