STANDARD OPERATION PROCEDURE (SOP)

1. STANDARD OPERATION PROCEDURE (SOP)

2. Why SOP? The purpose of SOP is to describe the Performance of a controlled process and if it is written to fulfill only that purpose efficiently and effectively, it becomes a rugged, flexible and valuable quality assurance tool

3. The following data which developed during R&D and Process Design will be well described in the SOP form • chemicals and components required including minimum quality, specifications, part numbers • Full description of any reagent, component or simple preparation and handling • A list of equipment required, its characteristics, capacity, precision and handling • Technician Training Requirement • Test methods or observations that ensure the effectiveness of process control and its documentation. • Processing control parameters and the techniques or methods that ensure their control and testing limit • Step-by-step description of the production process • Data-handling requirements with some examples for calculation • Reporting and documentation requirements

4. SOP FORMS • No governmental agencies have approved format for SOP • There are common expectations within the industry and from regulatory agencies that ensure the accountability, traceability and consistency of these documents • SOP usually one of the most important issue for company Audit • Small information or typing mistakes in SOP could be fetal

5. Don’t forget the following points when writing SOP!!!!

6. Company name and pagination: • the company name and pagination must appear on every page of the document. • Title: • The title should be descriptive. E.g. An SOP titles [Cell cultivation with temperature shift in bioreactor] is not descriptive of the procedure and should be change to [Operation method of 100 L bioreactor for cell cultivation using temperature shift strategy] • Identification and control: • Procedures must be uniquely identified. This identification supports accountability and traceability of the document throughout the facility and over time as it changes. The accountability and traceability of procedures are based on assigning them identification number or codes and control numbers or codes (revision and edition numbers) • Purpose: • The purpose or objective of a procedure should restate and expand a well-written title. Expand or quality the directive language used in the title (e.g. operation, monitoring and routine maintenance associated with CEPP and New Brunwsik Bioreactor)

7. Scope: • The scope should provide limits to the use of the procedure. Are there certain samples that are appropriate to test by this method? Do the operations apply only to certain equipment or to certain departments? Is there a limit to the capacity, volume or throughput of the procedure? State to what areas this procedure does and does not apply. • Responsibility: • Who is responsibility for the performing the work describes? Who is responsible for reporting the work? Are there special training for certification equipments? • Procedure: • Describe the procedure in a step-by-step, chronological manner. Use active verb and direct statement. E.g. Open the main switcher, Open valve number XYZ, Record the DO value after 30 minutes, etc. • Calculation/ data handling/ documentation requirements: • Describe how the raw data are managed and reported. Provide examples of calculations, when appropriate. • Frequency: • This should be written for maintenance and cleaning SOPs

8. Lets talk about SOP’s • What doesn’t require SOP? • How much details is enough? • Should we write specifications or results in SOP? • Who should write the SOP?

9. Lets develops our SOP!!!