Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Preface. Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products. Analytical Methods and Techniques for Biological Products. Laboratory Training Manual. Assessment of Training. Training Assessment with Quiz and Answers. Training Log. Analytical Method Validation Master Plan. Analytical Methods Validation Protocol. SOP for Annual Re-Qualification of HPLC Units. SOP for Annual Re-Qualification of GC Units. ABC Pharmaceutical Company. Regulations. Index.