Standard Operating Procedures for Regulation on use and Distribution of Biotechnology Products

Introduction

Standard operating procedures are a set of written instructions that are followed either repetitively or routinely. SOP is considered as a backbone of food and pharmaceutical industries. Standard operating procedures explains technical and fundamental program based operational tools of an organization that are managed according to a work plan or quality assurance (QA) project plan.

Need of standard operating procedures

1. It provides safety, healthy, environmental, and operational information to the public.
2. It ensures the continuity of the process with any interruption.
3. It ensures the completion of the process within a prescribed schedule.
4. It helps to maintain quality control of all the processes and products.
5. It ensures the success of the processes.
6. It also ensures the procedures which are followed are approved by the company and government.
7. It provides guidance and training for new staff.

Objectives of standard operating procedures

1. Describing the responsibilities of the coordinating center for managing and monitoring the participating sites.
2. Providing the necessary guidelines for accurate and timely data collection and resolution of data clarifications.
3. Maintaining the quality control and quality assurance of all the processes.
4. Ensuring compliance with governmental regulations.
5. To serve as a training document for teaching users about the process for which the SOP was written.

Areas of standard operating procedures

The SOPs are employed mostly in the following areas:

1. Dealing with complaints about products.
2. Analytical methods
3. Preparation of chemical reagents.
4. To check the quality assurance of the products.
5. To manufacture the instruments, laboratory equipment, and apparatus.
6. Safety and precaution of the products.

Writing method of SOPs

1. It should be written in a concise, step by step, easy to read.
2. The provided information should not be complicated.
3. The active voice and present tense verb should be used.
4. The range of words should be minimum.
5. The movement of one step to another step should be logical.
6. Some of the routine procedures that are short and require few decisions can be written using a simple steps format.
7. The long procedures, with few decisions, should be written along with graphical format or hierarchical steps.
8. The procedures which require many decisions should be written along with a flow chart.
9. Requirements for document identification and control, accountability, traceability, responsibility must be included with every standard operating procedure.
10. Warning caution must be used.

Format of standard operating procedure

1. Name of the company and pagination: The name of the company and the number of the page must appear on every page.
2. Title of the product: The title given should be in a descriptive manner.
3. Identification: The unique number and version number should be given to all the procedures for easy identification. The identification number of the standard operating procedures should support the accountability of the document throughout the facility and overtime as it keeps on changes.
4. Review and approval: All the standard operating procedures should have a proper space for the signature of:
   1. The person who has written the standard operating procedures (Initiator).
   2. The person who has reviewed the standard operating procedures (Reviewer).
   3. Quality assurance head of the company or organization (Approver).
5. Purpose: The objectives of the standard operating procedures should describe the operational procedure of the product.
6. Scope: The scope includes limits to use standard operating procedures.
7. Procedure: It describes the steps employed using active verbs and direct statements.

Types of standard operating procedures

There are 2 types of standard operating procedures are available:

1. Technical standard operational procedures: In this type the procedures are made to instruct the user of the product. It carries out specific analytical methods which need to be done in the laboratory, to collect a sample in order to preserve the sample integrity and representatives. It also covers data processing and evaluation, modelling and risk assessment.
2. Administrative or Fundamental programmatic standard operational procedures: In this type the standard operating procedures are made for administrative purpose. It performs reviewing documentation such as quality assessment project plans. It also includes co-coordinating the activity and record the results as well as coordinating the team efforts.

Process of standard operating procedures

The process of standard operating procedures involves five different steps such as:

1. Standard operating procedure preparation: There are only few authorities can write SOPs they are Equipment manufacturers, performs maintenance on equipment, environmental personnel, job performers, safety personnel, technical initiators.
2. Standard operating procedure review and approval: The procedures are reviewed by one or more individuals with proper training and experience with the process.
3. Frequency of revisions and reviews: Standard operating procedures should remain current for use. Sometimes changed standard operating procedures changes, and these changes should be updated and re-approved. The standard operating procedures should be reviewed periodically like every 1-2 years.
4. Implementing standard operating procedure: While implementing everyone should follow the procedure exactly with each and every step in detail. People need to understand the importance of procedure.
5. Management of standard operating procedure: The organization or company should have standard operating procedure on preparation, approval, revision and control of standard operating procedure for better control and management of standard operating procedure.

Benefits of standard operating procedures

1. It provides safety of the product to public.
2. It helps to prevent contamination and cross-contamination.
3. Reduces the variations in the potency of the product.
4. It also helps to reduce the side effects and toxicity of the products.

Also Read:

• Downstream processing and its steps
• Amino acids: Structure, Optical activity and Classifications
• Different Staining Methods used in Microbiology
• Biosafety Cabinet: Introduction, Development and Safety guidance
• Tryptophan Operon: History, Structure, Regulation and Attenuation
• Enzymes: Introduction, Enzyme activity and work Mechanism

References and Sources:

• https://www.slideshare.net/GajananSanap/documentation-142777368
• https://www.intechopen.com/books/latest-research-into-quality-control/standard-operating-procedures

Standard Operating Procedures for Regulation on use and Distribution of Biotechnology Products