Communication Documentation Method Validation 
GMPSOP
OCTOBER 26, 2022
Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.
GMPSOP
JULY 23, 2023
Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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. Additional documents included each month. Checkout sample preview s.
GMPSOP
MARCH 4, 2023
Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. What is the probability my cleaning methods weren’t validated?
FDA Law Blog: Biosimilars
FEBRUARY 13, 2025
The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks. In such cases, performance testing may be conducted again.
Expert insights. Personalized for you.
52 
Let's personalize your content