Remove Communication Remove Document Remove Method Validation
article thumbnail

Concept of validation in pharmaceutical industry

GMPSOP

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.

article thumbnail

A step-by-step guide to successful installation qualification (IQ)

GMPSOP

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Importance of acceptance criteria in analytical method transfer

GMPSOP

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.

article thumbnail

What is quality risk management in pharmaceutical?

GMPSOP

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?