Standard Operating Procedure

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve pre-determined specifications and quality end results. SOPs should allow for the continual improvement of standards of service, and provide evidence of commitment to protecting patients.

Benefits of SOP

  1. Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization:
  2. To ensure that processes continue uninterrupted and are completed on a prescribed schedule. Ensure against process shut-downs caused by equipment failure or other facility damage.
  3. To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. Following health and environmental steps in SOPs ensures against spills and emissions that threaten plant neighbors and create community outrage.
  4. To ensure that approved procedures are followed in compliance with company and government regulations. Well-written SOPs help ensures that government regulations are satisfied. They also demonstrate a company’s good-faith intention to operate properly.
  5. To serve as a training document for teaching users about the process for which those who need re SOP was written. Thorough SOPs are used as the basis for providing standardized training for employees who are new to a particular job and training.
  6. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. The process of actively caring about fellow workers involves one worker coaching another in all aspects of proper job performance. When the proper procedures are outlined in a good SOP, any coworker can coach another to help improve work skills.
  7. To serve as a checklist for auditors. Auditing job performance is a process similar to the observation mentioned in the previous item only it usually involves record-keeping SOPs and should serve as a strong basis when detailed audit checklists are developed.
  8. To serve as a historical record of the how, why, and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment is changed. As people move from job to job within and between companies, written knowledge and skills disappear from the workplace. Properly maintained written SOPs can chronicle the best knowledge that can serve new workers when older ones move on.
  9. To serve as an explanation of steps in a process so they can be reviewed in accident e investigations. Although accidents are unfortunate, view them as opportunities to learn how to improve conditions. A good Standard Operating Procedure (SOP) gives you a basis from which to be investigating accidents.

SOP Requirements

The data generated through these procedures should be maintained to show compliance with the above-mentioned requirements.

  • Prepare apex documents like Quality Policy, Quality Manual, Site Master File, Validation Master Plan, etc. to describe the quality commitments of the management
  • Define the roles and responsibilities of all personnel working in the organization
  • Prepare policy for periodic review of documents. Ensure that the current industrial practices and pharmacopoeial requirements are fulfilled by the current versions of documents.
  • SOP for the document (SOPS, MPCR, BPCR, validation/qualification protocols, formats) preparation, review, approval, training, distribution, control, and retention
  • Procedure for maintaining revision history
  • Management, control, and retention of superseded or obsolete documents
  • Document archival and retrieval procedure
  • Handling, archival, retrieval, and retention of electronic records/documents.
  • Procedure for control of electronic signatures
  • Equipment cleaning and sanitation procedure
  • Issuance and control of equipment logs
  • The document describes measures taken for avoidance of cross-contamination and its training records
  • Cleaning validation master plan
  • Procedure for batch-to-batch and product-to-product cleaning and its verification to ensure removal of the residue of previous batch/product
  • Records for incoming raw materials and packaging materials
  • SOP for preparation of process validation protocol and reports
  • SOP for preparation of master production control records
  • SOP for preparation of batch manufacturing and control records
  • SOP for allocation of batch number
  • Calibration master plan and calibration reports
  • Batch release procedure
  • SOP for preparation and control of QC datasheet
  • SOP for allocation of analytical control number
  • Procedure for review of analytical data
  • SOP for investigation of OOS results
  • SOP for change control, revision of any process or documents, or up-gradation of facility or equipment should be routed through impact assessment and change control procedure.
  • SOP for deviation handling system
  • SOP for corrective and preventive action (CAPA)
  • SOP for stability testing
  • SOP for product distribution and its control

Format of Technical SOP

In general, technical SOPs will consist of five elements:

  • Title page
  • Table of Contents
  • Procedures
  • Quality Assurance/Quality Control
  • References
  1. Title Page
  2. Table of Contents
  3. Procedures – The following are topics that may be appropriate for inclusion in technical SOPs. Not all will apply to every procedure or work process being detailed.

a) Scope and Applicability (describing the purpose of the process or procedure and any organization or regulatory requirements, as well as any limits to the use of the procedure),

b) Summary of Method (briefly summarizing the procedure),

c) Definitions (identifying any acronyms, abbreviations, or specialized terms used), Health & Safety Warnings (indicating operations that could result in personal injury or loss of life and explaining what will happen if the procedure is not followed or is followed incorrectly; listed here and at the critical steps in the procedure)

d) Cautions (indicating activities that could result in equipment damage, degradation of sample, or possible invalidation of results; listed here and at the critical steps in the procedure)

e) Interferences (describing any component of the process that may interfere with the accuracy of the final product),

f) Personnel Qualifications/Responsibilities (denoting the minimal experience the user should have to complete the task satisfactorily, and citing any applicable requirements, like certification or “inherently governmental function”),

h) Equipment and Supplies Listing and specifying, where necessary, equipment, materials, reagents, chemical standards, and biological specimens h. Procedure (identifying all pertinent steps, in order, and the materials needed to accomplish the procedure such as:

  1. Instrument or Method Calibration and Standardization
  2. Sample Collection
  3. Sample Handling and Preservation
  4. Sample Preparation and Analysis (such as extraction, digestion, analysis, identification, and counting procedures)
  5. Troubleshooting
  6. Data Acquisition, Calculations & Data Reduction Requirements (such as listing any mathematical steps to be followed)
  7. Computer Hardware & Software (used to store field sampling records, manipulate analytical results, and/or report data)

i) Data and Records Management (eg, identifying any calculations to be performed, forms to be used, reports to be written, and data and record storage information).

4. Quality Control and Quality Assurance Section – QC activities are designed to allow self-verification of the quality and consistency of the work. Describe the preparation of appropriate QC procedures (self-checks, such as calibrations, recounting, reidentification) and QC material (such as blanks-rinsate, trip, field, or method; replicates; splits; spikes; and performance evaluation samples) that are required to demonstrate successful performance of the method. Specific criteria should be included. Describe the frequency of required calibration and QC checks and discuss the rationale for decisions. Describe the limits/criteria for QC data/results and actions required when QC data exceed C limits or appear in the warning zone. Describe the procedures for reporting QC data and results.

5. Reference Section – Documents or procedures that interface with the Standard Operating Procedure (SOP) should be fully referenced (including version), such as related SOPs, published literature, or methods manuals. Citations cannot substitute for the description of the method being followed in the organization. Attach any that are not readily available.

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