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In general, you must formally validate all process steps, production equipment, cleaning methods, testing methods, computer systems and environment, facilities and utilities which are directly used for the manufacture of sterile and non-sterile products. This validation is relatively less comprehensive.
According to USP <1224> , method transfer is defined as the documented process that qualifies a laboratory (RL) to use an analytical method originating from another laboratory (TL), regardless of whether it’s internal or external. What is the analytical method transfer protocol?
According to FDA Guidance for Industry – Q9 Quality Risk Management , “Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. If my cleaning methods are not validated would they cause contamination of my products?
Add the objective of the installation qualification protocol Write the objective of the protocol defining the installation qualification (IQ) and operational qualification (OQ) requirements and acceptance criteria for the equipment with location i.e., packaging or manufacturing, and the facility.
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