Writing Effective SOPs and Good Documentation Practice

Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore the most popular documents audited by Regulatory Agencies during GMP inspections and all too often they result in observations.

This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOP’s that contribute to consistent and efficient operations. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP’s play in achieving the required level of compliance and quality.

This course is designed to assist with writing effective SOPs which contribute to the overall compliance of a company. What regulatory inspectors look for in SOPs, Good Documentation Practices, Global Harmonization of SOPs and maintenance of the SOP system though change control are also discussed.

· Regulatory inspectors expectations for SOPs

· The role of SOP’s with respect to GMP operations, global harmonization, documentation and document control.

· Good Documentation Practices

· Reviewing current SOP’s to determine gaps and overlaps to strengthen the existing documentation system.

· Maintenance of SOPs

· Designing an SOP template to optimize efficiency of organization and formatting of SOP’s

· The team approach to SOP writing, defining responsibilities and knowing the audience.

· The importance of capturing the actual flow of an operation within the document

· Writing tips on how to keep the document concise, unambiguous and accurate.

· Training of SOP documents

· Managing revisions and deviations through a document Change Control System