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SOP (Standard Operating Procedure): How to Write and Manage
SOP: Introduction and Outcome
SOP or standard operating procedure is one of the most important components of GLP and GMP. Be it synthetic R&D, analytical research, QC, producition, safety, HR, supply chain, finance and managements, each and every activity is carried out by SOP, so there is no doubt in saying that SOP decides organizational culture. SOPs are detailed, step-by-step instructions that guide personnel performing specific processes within the pharmaceutical development. That is why I decided to share my skill-based knowledge on this topic. In this article, I will discuss SOPs and its importance in pharmaceutical development.
Table of content
- Introduction and Outcome
- What is the SOP?
- Language of the SOP
- The person who prepare the SOP
- 11 Components of the SOPs
- Types of SOPs
- The SOP Management Process
- 5 Tips for Writing and Updating the SOPs
- Advantages of SOPs
- Location of the SOP
- Conclusion
- Interview questions on SOPs
What is the SOP?
SOP is a written procedure for a laboratory program. It defines how to carry out protocol-specified activities and are often written in a chronological listing of action step. SOP should full-fill the following criteria:
- SOP must contain unique number and revision number
- SOP must have page number and total page number
- For equipment testing: performance acceptance criteria, recommended corrective actions, and a template for continuous entries of test results and corrective actions should include
Language of the SOP
The SOP should be written in language that the person at the workplace can understand
Who prepare the SOP?
The following apers are involved in preparing SOP
- The concerned departmental person
- The concerned department HOD
- QA person and
- Other concern department head/designee
11 Components of the SOPs
Each SOP should contain the following sections;
- Approval
- Index
- Introduction
- General
- Objective
- Scope
- Responsibility
- Accountability
- Procedure
- References
- Abbreviations
Types of SOPs
In any pharmaceutical industries SOP is required at every stage from literature search to route selection, process control, manufacturing to release of pharmaceutical. Accordingly, there are various types of SOPs that are specific to each department and process. Then following types of SOPs are widely used in the pharmaceutical industry:
- Manufacturing SOPs: These SOPs outline the procedures for manufacturing pharmaceutical products, including formulation, blending, filling, and packaging.
- Quality Control SOPs: Quality control SOPs define the processes for testing, inspecting, investigating (OOS & OOT) and releasing raw materials, intermediates, and finished products.
- Cleaning and Sanitation SOPs: These SOPs provide guidance on cleaning and maintaining equipment, facilities, and manufacturing areas to prevent contamination and ensure product safety.
- Calibration and Maintenance SOPs: Calibration and maintenance SOPs outline the procedures for calibrating and maintaining equipment used in the manufacturing process.
- Documentation and Record Keeping SOPs: These SOPs detail the requirements for documenting and maintaining accurate records throughout the manufacturing and distribution processes.
- Training SOPs: Training SOPs cover the procedures for training personnel on various aspects, including safety protocols, specific manufacturing processes, and quality control measures.
- Change Control SOPs: Change control SOPs define the processes for implementing changes within the manufacturing or distribution processes while ensuring compliance with regulations.
- Deviation Management SOPs: Deviation management SOPs outline the procedures for identifying, investigating, and managing deviations from standard procedures.
- Analytical R&D SOPS: These SOPs outline the procedures managing Analytical activities such as method development, method validation, impurities control strategy, technology transfer, Analytical control preparation, lab management, routine activities etc.
- Synthetic R&D SOPS: These SOPs outline the procedures managing synthetic R&D activities
- Safety SOPs: Safety SOPs are integral part of all departments
Note:
- Each department should have their own SOP. SOPs are designed and finalized as per department need
- It is important for pharmaceutical companies to develop SOPs specific to their operations, ensuring that each process is documented and standardized according to regulatory requirements.
The SOP Management Process
Developing, implementing, and maintaining SOPs require a structured management process. Here are the key steps involved in effective SOP management:
- Initiation: Identify the need for a new SOP or updates to existing SOPs based on changes in processes, regulations, or best practices.
- Preparation: Gather relevant information and involve subject matter experts in the preparation of the SOP. Clearly define the objectives, scope, and responsibilities associated with the process.
- Approvals: SOPs should go through an approval process involving key stakeholders, including department heads, quality assurance personnel, and regulatory affairs experts. Obtain the necessary signatures and approvals before implementing the SOP.
- Implementation: Communicate the approved SOP to all relevant personnel and ensure that they understand and follow the procedures outlined. Provide any necessary training or support to facilitate the implementation process.
- Training: Conduct training sessions to educate personnel on the SOP, its importance, and their roles and responsibilities in adhering to it. Regularly review and update training materials as needed.
- Maintenance: SOPs should be regularly reviewed, updated, and maintained to reflect any changes in processes, regulations, or best practices. Assign a designated individual or team responsible for managing and maintaining the SOPs.
By following a structured SOP management process, pharmaceutical companies can ensure that their SOPs remain up to date, effective, and compliant with regulatory requirements.
5 Tips for Writing and Updating the SOPs
Writing and updating SOPs requires careful attention to the concerned department or related activity. Here are some tips to consider when creating or revising pharmaceutical SOPs:
- Familiarize yourself with the approved SOP Format: Understand the standard format and structure of SOPs in the pharmaceutical industry. Ensure that your SOP adheres to the required format to maintain consistency across all SOPs.
- Involve Subject matter experts: Collaborate with personnel who have expertise in the specific process or task being documented. Their input and knowledge will ensure the accuracy and effectiveness of the SOP.
- Be clear when writing SOPs: Use clear and concise language to convey instructions. SOPs should be easy to understand and follow by personnel at all levels of the organization.
- Use Graphical representation: Incorporate flowcharts, diagrams, and images where appropriate to enhance understanding and clarity. Visual representations can simplify complex processes and make SOPs more accessible.
- Include Relevant signatures/approval process: Ensure that SOPs include spaces for relevant signatures, indicating approval and acknowledgment of understanding. Signatures provide accountability and demonstrate compliance with the SOP.
Regularly review and update SOPs to reflect changes in processes, regulations, or best practices. Seek feedback from personnel who use the SOPs regularly to identify areas for improvement and ensure that the SOPs remain effective and relevant.
Advantages of SOPs
The following are the advantages of SOP:
- Enhancing Regulatory Compliance
- Ensuring Consistency and Quality
- Increasing Efficiency and reducing the cost
- Promote Accountability and Responsibilities at organizational levels
- Improve safety
- Track and measures the organizational proficiency
- Reduce error
- Increase communication between different department
- Enables proper onboarding and training
- Reduce time in operating and celebrational activities such as Development, Validation, Technology transfer and Instrument calibration
Regulatory Compliance
One of the primary reasons SOPs are crucial in the pharmaceutical industry is regulatory compliance. Regulatory bodies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) require pharmaceutical companies to have well-documented SOPs for their operations. During inspections, regulators review these SOPs to ensure that processes and procedures are being followed correctly. Failure to have proper SOPs or deviations from approved SOPs can lead to warnings, non-compliance, and potential patient safety risks.
Ensuring Consistency and Quality
SOPs are meticulously written and verified to ensure accuracy and consistency in the pharmaceutical development and manufacturing processes. They provide step-by-step instructions that guide personnel in executing tasks precisely. By following SOPs, pharmaceutical companies can achieve consistent results in terms of product quality, safety, and efficacy. SOPs help prevent deviations from standard procedures and reduce the risk of human error, ensuring that each batch or lot meets the required quality standards.
Increasing Efficiency and reducing the cost
SOPs help streamline processes, eliminate inefficiencies, and optimize workflows. They provide a standardized approach to executing tasks, ensuring that all personnel involved are following the same procedures. By eliminating variations and unnecessary steps, SOPs contribute to increased efficiency, productivity, and cost-effectiveness in pharmaceutical operations.
Promote Accountability and Responsibilities at organizational levels
SOPs clearly define the roles and responsibilities of each individual involved in a specific process. This ensures that tasks are assigned to the appropriate personnel and that there is no overlapping of responsibilities. By clearly outlining the responsibilities, SOPs facilitate effective delegation and accountability within the organization. This clarity and structure help in maintaining a well-organized and efficient workflow.
Location of the SOP
Instrument SOPS should be kept close to the instrument and department sop should be kept in the department and operational SOP should be kept at the designated place .
Conclusion
In conclusion, SOPs are an essential tool in the pharmaceutical industry for ensuring compliance, consistency, and efficiency.I hope this article has helped you understand SOP and its importance. Now you can design, write and implement the SOP in your department . You may also want to check out other articles on my blog, such as calibration of UPLC, Calibration of UV and Calibration of pH meter
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FAQs
What is the standard test procedure or SOP?
SOP is written, defined and approved procedure to conduct operational and calibration activities.
What are the different types of SOPs?
There are two types of SOPs, operational and calibration
What are the 5 standard operating procedure?
Title page, table of content, procedures, approval and references are the 5 standard operating procedure
What is the main purpose of the SOP?
The main purpose of SOP is to perform activities using defined procedures to avoid error, enhance quality, maintain safety and efficacy
What are the 4P’s of the SOP?
Philosophy, Policy, Procedure and performance are the 4P’s of the SOP
What is an SOP checklist?
Purpose, Responsibility, approval, procedure, references and abbreviations are check list of SOP.
How to write SOP?
SOP should be written as per department or as per instrument needs. Department person and QA should involve in writing the SOP.
Who implement the SOP?
Department head in coordination with QA implement the SOP
What are the advantages of the SOP?
SOP enhances quality, efficacy, safety and cost-effectiveness
References
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kilitch-healthcare-india-limited-672956-03282024
- GLP and cGMP; ludwig Huber; Agilent technology
- https://www.usp.org/compounding/general-chapter-797
Abbreviations
- SOP: Standard operating procedure
- QC: Quality control
- QA: Quality assurance
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