1. Standard Operating Procedure What is an SOP? Who should Write? Format and Content of SOPs How to Implement Managing Change Control Who is Responsible? Who looks at them?

2. 2 Standard Operating Procedures (a.k.a. SOPs) Documents that describe a specific procedure in detail Living documents that represent current practice Official documents that can be used in court. Signed approvals indicate responsibility. FDA requirement as stated in the drug cGMPs (CFR 21 Parts 210 & 211)

3. 3 In fact... SOPs are mentioned 23 times in the drug GMPs –“There shall be written procedures... “ –“Such written procedure shall be followed..“

4. 4 SOP’s are important because They provide a written record of a specific procedure They can be used as a training tool They provide the FDA with evidence that company is in control of there procedure & processes They make good business sense

5. 5 When do you need to write an SOP? GMP regulations specify some instances. However, additional procedure relating to the development and/or manufacture of drug products should also be in SOP format SOPs are not intended to restrict experimental activities in the product development process

6. 6 Getting Started... Identify individual or group responsible for the process Agree on a format (template) and or process for review, approval, and distribution of the documents (write an SOP for SOP’s) Identify procedures to be written Assign writing responsibilities to appropriate individuals Review and solicit comments as needed until the document is acceptable

7. 7 SOP Format Header Body Footer Attachments

8. 8 SOP Header Title SOP Number (XXX-YYY-ZZ) Effective Date Approvals (document, control, writer, manager/supervisor, QA or GMP coordinator) Other information

9. 9 SOP Body Purpose – the reason for writing the SOP Scope – the limitations of the procedure Responsibility – positions responsible for specific parts of the procedure Procedure – step by step instructions Documentation – necessary to support the procedure

10. 10 SOP Footer/Attachments The SOP must be paginated Attachments – part of the SOP or separate?

11. 11 Tips... Write clearly and concisely avoiding excessive detail Avoid using jargon unless absolutely necessary Watch grammar and spelling – use of shall, will, should, can Be careful referencing other SOPs Be careful with attachments and forms

12. 12 Maintaining SOPs Document Specialist Quality Assurance/Quality Control Change control Availability and distributions of copies –Paper copies –Electronic copies Training Periodic Review Archiving

13. 13 Finally... It is a concern if an SOP is not in place It is a violation if a SOP is in place but not followed Map out what you need to accomplish Set realistic goals for writing/prioritize Utilize learning from other areas Assess the quality and relevance of SOPs