2014, FDA and Method Validation - Pharmacy Technician Pulse

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

2014

FDA

Method Validation

Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

JANUARY 11, 2023

Validation of Cleaning Processes (7/93): Guide to Inspections Validation of Cleaning Processes.” August 2014. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Bethesda, MD: PDA and River Grove, IL: DHI Publishing, 2014. January 2012.

Method Validation

Method Validation Documentation Packaging Compounding

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

Documentation

Documentation FDA Communication Packaging

Life-Cycle Approach to Cleaning Topical Drug Products

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Stay Connected