Attend the seminar Quality Control Laboratory Compliance - cGMPs and GLPs to examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions.

Jan 21, 2025 · CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing...

A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Similar concepts apply to bulk drugs.

Quality Production Laboratory Materials Facilities and Equipment Packaging and Labeling Regulatory Education for Industry (REdI): Focus on CGMPs & FDA Inspections

Mar 14, 2023 · Testing raw materials at your quality control laboratory when you receive them is no longer enough, especially if you're dealing with critical materials. Today, pharma companies need to audit their suppliers and establish effective working relationships actively.

Nov 1, 2023 · This paper provides a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and related public quality standards. It discusses GMP compliance requirements and practices, emphasizing those relevant to the analytical chemist in development and quality control.

Sep 2, 2006 · This article identifies key components of a laboratory control system and discusses current cGMP practices and challenges. The Laboratory Facility Facility personnel designate cGMP areas on the building's floor plans.

Mar 1, 2023 · Current Good Manufacturing Practice, also known as cGMP, are a set of regulations that ensure the quality of pharmaceutical products, medical devices, biotechnology products, food and beverage, and dietary supplements. They therefore apply to all organizations involved in the manufacturing processes of these products.

Nov 4, 2024 · cGMP guidelines cover every aspect of production, from facility design to staff training, equipment calibration, quality control, and record-keeping. These practices help prevent contamination and errors, safeguarding consumers from harmful products.

We offer cGMP lab services to support drug product development. CMC Pharma can execute laboratory studies under cGMP guidelines to meet your project needs. This means that data generated in our lab may be used to support filings with the U.S. FDA when cGMP lab studies are required for product approval.