Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
The purpose of the GxP quality guidelines is to ensure a product is safe and meet its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics.
- Pharmaceutical cGMPs for the 21st Century
- EU-GMP guidelines (European union-GMP guidelines)
- WHO-GMP guidelines (World health organization-GMP guidelines)
- GMP for active pharmaceutical products
- GMP for biopharmaceuticals
- cGMP quality principles for biologics and biotechnological products
- Licensing in pharmaceutical production & GMP documentation
- Issuance and retrieval of GMP records
- Cancellation of GMP records
- Good Documentation Practice (GDP)
- Role of GxP in medical and food industries
- Good Engineering Practice (GEP)
- Good Auditing Practice (GAP)
- Good Review Practice (GRP)
- Role of GxP and c GxP in biopharmaceutical Industry
- The Role of c in cGMP
Related Conference of Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
February 27-28, 2025
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Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals Conference Speakers
Recommended Sessions
- Pharmaceutical Audit
- Auditing Deviations, Product Complaints, and CAPA Systems
- Best Industry Practices
- Biologics & Biosimilars
- Clinical Affairs & Regulatory Strategies
- Contract and Sterile/Aseptic Manufacturing
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
- Current Regulations and Quality Standards
- Excipient Qualification and Supply Chain Controls
- Formulation Development
- Global Regulatory Intelligence
- GMP in Food Industry, Microbiology & Biotechnology
- Good Clinical Practices and Good Laboratory Practices
- Good Manufacturing Practices: The Gap Within
- Impact of Brexit on Regulatory Framework
- Intellectual Property Rights
- Medical Device & Combination Products Regulations
- Penalties for Regulatory Non-compliance
- Quality Control & Quality Assurance
- Quality Management System in Testing Laboratories
- Regulatory Affairs
- Regulatory Challenges for Medical Devices
- Regulatory Communications and Submissions
- Regulatory Requirements for Pharmaceuticals
- Softwares in GMP and GCP
- Storage, Distribution, Transportation
- Validation
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