SOPs for Regulatory Applications for the Pharmaceutical Industry

Launched June 2013 11 lectures
Dr. Laura Brown
LB Consulting UK and Cardiff University, UK

Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOPs) provide the main forum for the documentation of a pharmaceutical company's systems and operations and compliance with GXP such as GCP, GPV, GMP and GLP. SOPs are... read moretherefore amongst the most critical documents inspected by Regulatory Agencies during GXP inspections. Inspectors review whether they reflect current practices and regulatory requirements and are followed as written. Every department in research and development is required to have SOPs as part of their quality systems.

SOPs are used to ensure consistency and quality within the pharmaceutical organisation and also ensure compliance with regulatory requirements as well as providing a basis for ensuring that the correct people are trained for their specific roles in a GXP environment.

The functions of SOPs include:
• Ensure compliance with GXP regulatory requirements
• Training of staff
• A means of standardisation and sharing of best practice
• A tool to help manage the workplace
• An audit document – training, risk, best practice
• Document control of procedures