SOP Management Practices Quiz

GMP (Good Manufacturing Practice) and SOP (Standard Operating Procedure)

• GMP is a set of written instructions.
• GMP aims for transparent, understood, and achievable quality objectives.
• SOPs are sets of procedures.
• SOPs are used in pharmaceutical industries.
• SOPs include both technical and operational elements.
• SOPs are managed under a work plan or a Quality Assurance (QA) Project Plan.
• FDA documentation rules:
  • If it isn't written down, it didn't happen.
  • If it isn't written down properly, it didn't happen either.
  • Don't forget rules 1 and 2.
• SOPs are 3rd layer in documentation, following GLP and company policies (first and second layers respectively).

SOP Objectives

• Describe responsibilities for managing sites.
• Provide accurate and timely data collection.
• Detail regularly recurring work processes.
• Facilitate compliance with technical and quality systems.
• Maintain Quality Control and Quality Assurance processes.
• Ensure compliance with governmental regulations.
• Serve as a training document about the procedure.

SOP Why it Is Essential

• Fundamental part of a successful quality system.
• Essential for plant effectiveness and efficacy.
• Essential for regulatory requirements.
• Ensures consistent production operations for quality control.
• Ensures uninterrupted and scheduled completion of processes.

SOP Benefits

• Provides information for proper job performance.
• Includes all safety, health, and environmental information for proper job performance.
• Provides consistency.
• Achieves pre-determined specifications and quality results.
• Minimizes variation and promotes quality (reviewed during accident investigations).
• Serves as training documents.
• Ensures GMP is followed and achieved at all times.
• Avoids confusion and function overlapping, while ensuring accountability and responsibility.
• Assures the quality and consistency of service, thus minimizing harm to patients.
• Useful tools for training new staff.
• Gives clarity for employees to follow steps/procedures systematically and uniformly.

Types of SOP

• Safety and Precautions
• Analytical Method
• Methodic
• To Deal With Complaints
• Instruments/Equipment & Apparatus
• Fundamental
• Prep. Of Reagents
• Q.A.

SOP Writing Style

• Concise, step-by-step, easy to read, and follow format.
• Avoid complicated information; use active voice and present tense verbs.
• Keep information simple and short.
• Short procedures with few decisions can use simple steps format.
• Long procedures (over 10 steps) require graphical or hierarchical steps.
• Procedures requiring many decisions need flow charts.
• Document identification and control, accountability, and traceability responsibility must be consistent.

SOP Writing Guidance

• Write in present tense.
• Avoid past, conditional, or future tense unless necessary.
• Avoid ambiguity.
• Keep words short and get to the point.
• Move from one step to another step logically.
• Highlight exceptions with a symbol and handling instructions.
• Highlight warnings using larger fonts or icons.
• Reduce word count without altering meaning.
• Avoid introducing acronyms without explanation.
• Avoid using "may" or "if possible"; be positive and direct.

Inside the SOP

• Include company name and pagination (e.g., page 4 of 7).
• Use descriptive titles with directive language.
• Use unique numbers and version numbers for procedure identification.
• Ensure accountability and support throughout the facility as it changes.

SOP Review and Approval

• SOPs should be reviewed by individuals with adequate training and experience.
• Draft SOPs should be tested by individuals other than the original writer before finalization.

SOP Frequency of Revisions and Reviews

• SOPs need to remain current to be useful.
• Whenever procedures change, SOPs should be updated and re-approved.
• Relevant sections should be modified, with change dates and revision numbers noted within the Table of Contents and document control.
• SOPs should be systematically reviewed periodically (e.g., every 1-2 years).
• Review SOPs to ensure compliance with current policies and procedures.
• Review to see if SOPs are still necessary.

Implementing SOP

• Training is a crucial step.
• Employees should follow the procedure exactly with each and every step in detail.
• Training should explain the why behind the SOP.
• Reinforce the importance of the procedure and detail its impact and implications for staff, production, personnel, and equipment.
• Demonstrate how every step of the SOP will be performed and provide safety and accuracy to increase user confidence.

SOP Management

• Organization should have a procedure to determine which procedures or processes needed to be documented.
• SOPs should be written by individuals who perform the tasks on a routine basis or those directly responsible for completing the tasks.
• Ideally, a system owner should eliminate obsolete SOPs, ensure SOPs meet quality requirements, manage change controls, and distribute and maintain current SOPs.
• The system owner needs to ensure that all new or revised SOPs are validated after sufficient training and reporting performance measures.

SOP for Cleaning of Vessels

• Fill the tank with hot tap water (50-60°C).
• Pass steam through the jacket.
• Drain the water.
• Fill with water-detergent mixture (0.1% Teepol).
• Heat and drain the water.
• Rinse with plain hot water (at least twice).
• Clean the exterior with warm water and the interior with distilled water.
• Dry with steam and then apply label.

SOP for Mixing of Aqueous & Oily phase

• Check outlet valves and label for closed status.
• Open the inlet valves and transfer aqueous/oily phases from their respective mixing tanks.
• Heat and agitate according to determined rate and specified time.
• Monitor mixing process through sight glass intermittently.
• Stop agitation/heating after the specified time gap.
• Cool and homogenize the product.
• Transfer finished product to the filling unit.
• Record all processing details.

SOP for Packaging & Labeling

• Ensure the container is clean and dry.
• Open the lid.
• Place containers below the syringe nozzle.
• Adjust volume to be filled per container.
• Turn on the filling machine.
• Check the process intermittently.
• Turn off the machine when completed.
• Replace the lid.
• Apply a sticker label.
• Put the containers in the final container.
• Report packaging and labeling details.

SOP for Liquid Mixing

• Ensure the tank is closed and marked as cleaned.
• Close the bottom tank valve.
• Open the mixing tank lid.
• Transfer water and materials as per the Batch Mixing Record (BMR).
• Close the mixing tank lid.
• Run the stirrer for the designated time with speed adjustments.
• Shut off the stirrer after mixing.
• Apply status labels.

SOP for Filtration (Filter Press)

• Confirm equipment is clean for use.
• Fill the tank with 25 liters of syrup and 1 kg of filter aid.
• Pump the slurry into a chamber, displacing air from the top.
• Stop the outlet when filtration starts.
• Remove and recirculate the filtrate until it is clear.
• Connect to filter press pump and open the valve.
• Filter the result and send to pre-cleaned storage tanks.
• Label the tank properly.

SOP for Rotary Bottle Washing Machine

• Examine glass pieces for removal.
• Fill trays with fresh distilled water (DM water).
• Clean stainless steel trays before loading.
• Remove broken bottles before washing.
• Adjust holder sizing and fixing to the stainless steel platform.
• Change the pump switch settings for adjusting the pump pressure as needed.
• Put bottles inverted on the washing nozzles.
• Unload bottles into an aluminium, clean, perforated tray.
• Dry washed bottles in the oven at 120°C for 1 hour.

Conclusion

• SOPs facilitates communication in an organization at all levels.
• The structure of SOPs supports cross-functional engagement to allow for effective management.
• A well implemented system requires employees, management, production, and equipment processes to function together.
• Best practices are improved, and maintained when procedures are followed.

Other Topics Covered

• Introduction Semisolid & Liquid Dosage Forms
  • Semisolid: Cosmetics, Gels & Jellies, Cream, Toothpaste, Plaster, Nail Lacquers, Suppositories, Lipstick, Facewash.
  • Liquid: Simple Solutions, Drops, Syrups, Elixirs, Suspension(Solid in Liquid), Emulsion(Liquid in Liquid).
• Common Equipment (as per GMP)
• SOP Preparation: Procedure to determine need for a documentary process. A task or process is documented by a routinely involved or responsible individual.
• Who can Write SOP? Environmental personnel, performers, equipment manufacturers, safety personnel, technical initiations, equipment maintenance personnel.

Test your knowledge on the key responsibilities and best practices for managing Standard Operating Procedures (SOPs). This quiz covers aspects such as SOP distribution, purpose, structure, and critical components that ensure their validity. Ideal for those looking to enhance their understanding of SOP management.