Writing effective SOPs and Good Documentation Practice

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Description

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

Overview

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 company's systems and operations. SOPs are therefore the most popular documents audited by Regulatory Agencies during GMP inspections and all too often tey result in observations.

This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOPs 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 SOPs play in achieving the required level of compliance and quality.

The course material is presented by means of slides, handouts and participation of the attendees through discussion and individual/group exercises.

Note: Participants may bring an SOP related to their work for the workshop exercise on day two where individual questions will be addressed. Confidentiality will be respected.

This course will deliver the tools to enable you to:

  • Consider the impact of not following SOPs as wsritten
  • Understand the key role SOPs play in the overall quality and compliance system
  • Use SOPs to improve the efficiency of operations
  • Write user friendly documents which are easily followed and reflect current practice

Who Should Attend?

This Two-day course is valuable for Managers, Supervisors, Laboratory Analysts, operators who are involved in the organization, writing or management of SOPs required fr GMP purposes in the Pharmaceutical and related industries with daily responsibilities in the following areas:.

  • Quality Assurance
  • Documentation
  • Compliance
  • Regulatory Affairs
  • Production
  • Laboratory
  • Training

Course Programme

Questions and answers will be taken throughout the duration of the course.

Day 1

8:45 am Registration and Coffee

9:15 am to 10:30am

  • Introduction - Exercise
  • Benefits of SOPs
  • Regulatory inspectors expectations for SOPs

10:30 am Morning refreshments

10:45 am to 12:15pm

  • The role of SOP's with respect to GMP operations and Quality Systems
  • Global Harmonization
  • Good Documentation Practices

12: 15pm Lunch

1:30 pm to 3:00 pm

  • Maintenance of SOPs
  • Reviewing current SOP's to determine gaps and overlaps to strengthen the existing documentation system.
  • Designing an SOP template

3:00 pm Afternoon refreshments

3:15 pm to 4.45pm

  • Exercise
  • The Team Approach to SOP writing

Day 2

9:00 am to 10:15 am

  • Defining Responsibilities and signatures
  • Ensuring the flow of the document for a consistent outcome
  • Exercise

10:15am Morning refreshments

10:30 am to 12:00 pm

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

12:00 pm Lunch

1:00pm to 2.30pm

  • Training of SOPs
  • Exercise
  • The Change Control System

2:30pm. Afternoon Refreshments

2:45 pm to 4:30 pm

  • Managing Revisions
  • Recap
  • Individual SOP work

4:30pm Course Closes and Certificates

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