The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies to consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
Why these FDA Guidance/EU Guidelines for Industry - Process Validation is so important to the pharmaceutical and biotechnology industry.
What FDA segments are included and excluded within the "NEW" Process Validation.
Where does the Process Validation commence.
What are the Three Stages and Where DThey Apply within the NEW Process Validation.
How Stage 1 integrates with Phase 1.
The Validation approaches that are included within this Guidance document.
The Statutory and Regulatory Requirements for Process Validation.
An Introduction tPhase 1 Guidance for Industry and Its Application within the "NEW" Process Validation.
The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required.
General Considerations for Process Validation - Stage 2 Process Qualification.