Writing effective SOPs in a GMP environment

Course objectives:

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 to ensure they reflect current practices and are followed as written.

This course provides helpful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOP’s. 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.

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.

The workshop emphasises practical issues such as:
     • The benefits of SOP’s
     • The logical approach to defining and writing the procedure section of the SOP
     • Writing SOP’s as part of a team
     • Critiquing an example of a badly written SOP

The course provides ample opportunities for group discussions and hands on exercises. It enables participants to gain the skills and knowledge necessary to meet the expectations of regulatory agencies.

This course will deliver the tools to enable you to

• Understand the purpose and benefit of effective SOPs
• Understand the critical role of SOPs in Quality Documentation systems
• Use various tools such as flowcharting to define a logical procedure
• Write a concise, unambiguous SOP for its intended purpose
• Ensure the document is written for the correct audience
• Link SOPs to good documentation practices
• Define clear responsibilities in order to promote action and closure within the document
• Manage revisions, non conformance and deviations from a current SOP
  

Who should attend:

This Two-day course is valuable for all personnel who are involved in the organisation, writing or management of SOP's required for GMP purposes.

• Quality Assurance

• Documentation and Technical Writing

• Quality Control Laboratory

• Regulatory Affairs

• Contract Laboratory

• Analytical Laboratory

• Project Management

• Training
• Validation
• Consultants

Course outline:

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

Day 1
8.30 Registration and Coffee

Morning Session 1 - 9.00 to 10.30am
     • Introduction
     • Individual Exercise
     • Benefits of SOPs
     • Global Harmonisation of SOP’s

10.30 Morning refreshments

Morning Session 2 - 10.45 am to 12.30pm
     • Overview of Regulatory Expectations
     • The Role of SOP’s in Quality Documentation Systems
     • Good Documentation practices

12.30 Lunch

Afternoon Session 1 - 13.30 to 15.00pm
     • SOP Maintenance
     • Group discussion (Paper versus electronic maintenance)

15.00 Afternoon refreshments

Afternoon Session 2 - 15.15 to 17.15pm
     • Designing an SOP template
     • Exercise (groups of 2 or 3 people)

17.15pm End of day

Day 2

Morning Session 1  - 9.00 to 10.30am
     • Review exercise for end of day 1
     • The team approach to SOP writing
     • Defining responsibilities and knowing the audience

10.30 Morning refreshments

Morning Session 2 - 10.45 am to 12.30pm
     • Ensuring the flow of the document
     • Group exercise
     • Writing tips for a concise, unambiguous document

12.30 Lunch

Afternoon Session 1 - 13.30 to 15.15pm
     • Writing tips for a concise, unambiguous document (continued)
     • SOP’s as a training tool
     • Exercise – critique a badly written SOP
     • SOPs and the Change Control System

15.15 Afternoon refreshments

Afternoon Session 2 - 15.15 to 17.00pm
     • Managing revisions, Non-conformance and Deviations
     • Final Advice and Summary
     • Individual SOP work

17.00pm End of day