Standard Operating Procedures (SOP)

Draft Standard Operating Procedures for your facility.

What are Standard Operating Procedures (SOP)?

  • SOP is a procedure specific to a task or an operation that described in the process. It is a controlled document that instructs “how to” perform a task.
  • SOPs are drafted in compliance with GMP, Health Canada regulations, industry standards, provincial laws and corporate policies. 
  • The role of the SOP is t0 ensure robust, reproducible and compliant processes
  • SOPs enhance regulatory compliance and minimize safety risks 

SOP Categories

  1. Manufacturing SOPs:

  • Detailed procedures for pharmaceutical manufacturing processes
  • Batch record maintenance, equipment calibration, and quality control protocols
  • Standardization of production workflows to maintain consistent product quality
  1. Quality Assurance SOPs:

  • Guidelines for quality control, sampling, and testing procedures
  • Documentation and reporting requirements for product release and rejection
  1. Regulatory Compliance SOPs:

  • SOPs related to regulatory submissions, inspections, and audits
  • Ensuring adherence to guidelines set by regulatory authorities
  • Documentation and reporting requirements for regulatory compliance
  1. Risk and Safety SOPs:

  • Procedures for handling hazardous materials, waste management, and safety protocols
  • Emergency response plans and incident reporting guidelines
  • Ensuring a safe working environment for employees and minimizing risks

SOP Development and Implementation:

  1. SOP Drafting Process:

  • Step-by-step guide on developing effective SOPs
  • Involvement of key stakeholders and subject matter experts
  • Ensuring SOPs align with industry regulations and organizational objectives
  1. SOP Approval and Authorization:

  • Outlining the SOP review and approval process
  • Roles and responsibilities of personnel involved in authorization
  • Documenting changes and version control for SOP updates
  1. SOP Training and Communication:

  • Training matrixes to ensure understanding and compliance of procedures across the enterprise
  • Strategies for effectively communicating SOPs to employees
  • Utilizing technology for efficient distribution and access to SOPs

SOP Management and Continuous Improvement:

  1. SOP Review and Revision:

  • Establishing a periodic review process for SOPs
  • Incorporating feedback and lessons learned for continuous improvement
  • Ensuring compliance with changing regulations and industry best practices
  1. Documentation and Record Keeping:

  • Importance of maintaining accurate and up-to-date SOP documentation
  • Organizing and archiving SOPs for easy retrieval and reference
  • Electronic systems and databases for efficient management of SOP records
  1. Auditing and Assessments:

  • Conducting internal and external audits to evaluate SOP compliance
  • Implementing corrective and preventive actions based on audit findings
  • Continual assessment of SOP effectiveness and identifying areas for improvement

Get in Touch with Your SOP Expert

Find out what SOP solutions would work best for your business.
For more information about Standard Operating Procedures (SOP) and the h0w they will increase efficiency of your processes

Please feel free to contact us.