Documentation - The First and Last Exit in GMP
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The document outlines the policies and procedures for managing tasks in an organization, emphasizing the distinction between policies, procedures, and instructions. It provides guidance on creating effective Standard Operating Procedures (SOPs) and highlights the importance of clear instructions for various tasks. Workshops are suggested for writing cleaning policies and SOPs, along with the necessary components to include for effective governance.
Documentation - The First and Last Exit in GMP
- 1. Documentation The First & Last Exit in GMP 02 Nov 2019, Karachi Policies & Procedures
- 3. 2 Policies and Procedures
- 4. Policies • Documents used to influence and dictate actions / decisions • Broad in scope and affect typically different organizational/ business/ geographical units • Describes requirements but NOT specifics on how to accomplish tasks
- 5. Policies Directions reflecting vision ……Where to go …… How to go? … How to execute? … How to move ? … What not to do? …
- 6. Procedure Set of instructions that describes a task or process. A specified way to perform an activity
- 7. Instructions The specific, detailed requirements for performing a particular task
- 9. Consistent Construct Continuous What, Why and How
- 10. Consistent Construct Continuous Clear CompleteCorrect
- 11. Question You have a Cleaning Policy in place but don’t have a procedure to execute for cleaning of water tank inside GMP zone It is outsourced & performed by 3rd party, you are unaware about the procedure of cleaning used by them. What is your point of view? Explain please 5
- 12. Question If a mixer is run for 15 minutes, it mixes the materials because it is repeated 3 times and validated, So there is no need for in-process tests 6
- 13. Workshop Write instruction how to clean a pipe piece used in filling of water in manufacturing unit Write instructions to hang a wall clock, adjust its time, change of its battery periodically, and its monitoring OR
- 14. Workshop What others aspects should be included in SOP other than instructions
- 15. Workshop How to write • Concept …begin with the end in mind • Select a format (approved) • Collect the inputs • Define scope • Identify the audience • Write SOP • Send for review • Answer the questions • Get it authorized
- 16. Workshop Write Cleaning Policy (An outline) • Statement • Principle, values, philosophy • Detail objectives • Strategy to achieve objectives • Specific actions when required • Desired outcome of specific actions • Performance indicators • Review program
- 17. Thank You