GMPSOP

OCTOBER 26, 2022

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.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

GMPSOP

JULY 23, 2023

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.

Documentation 52

Documentation Method Validation Packaging Labelling 52

GMPSOP

JUNE 16, 2023

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?

Documentation 52

Documentation Dosage Communication Method Validation 52

GMPSOP

MARCH 4, 2023

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?

Documentation 52

Documentation Communication Method Validation Packaging 52