May 26, 2014


How Good Are Our SOPs?

Standard Operating Procedures (SOPs) are high-level written instructions for performing recurring procedures safely, accurately, consistently, and efficiently. In the Healthcare industry, SOPs help in meeting business and regulatory requirements and in achieving compliance with the law. Sections of regulations such as 21 CFR Part 58, 210, 211, 310, 314, 820 refers to well-written, reviewed, and revised SOPs in one way or the other. Most of the SOP related FDA-483s, revolve around absence of SOPs, failure to maintain or implement them, and/or ignorance of the companies to train employees properly on using SOPs. Many of the warning letters received by the pharmaceutical companies are because of inadequate, uncontrolled, and outdated procedures.

Consequently, there is a growing need for organisations to check the quality and effectiveness of their SOPs. Some of the checkpoints that might help in re-visiting and improving our SOPs require focus over the following areas:

SOP Development

  • Use a well-defined template for writing including all the mandatory fields such as Title, Versioning, Effective date, Revision history (21 CFR Part 820.40)
  • Write clear, short, simple, and user oriented sentences in active voice using an instructional tone
  • Refer regulatory guidelines without copying the entire regulation (describe actual processes)
  • Supplement the SOPs with Flowcharts, Job Aids, Notes, and Appendices
  • Include all the required signatures and approvals (21 CFR Part 211, 820) with their meaning

SOP Testing & Implementation

  • Get the SOPs peer-reviewed and quality checked
  • Test the SOPs through new users ( experienced user might miss steps)
  • Dry-run the SOPs
  • Train all the required people on SOPs and maintain a training log
  • Encourage employees to use SOPs for internal communication

SOP Control & Maintenance

  • Keep SOPs in secure locations that can be accessed by the employees and reproduced during audits (21 CFR Part 58.81)
  • Have a well-defined revision process including proper document management system to update SOPs against changes or mistakes (21 CFR Part 820.40)
  • Update Revision history when there is a change in roles, responsibilities, requirements and processes; do not update for grammar or format changes
  • Audit SOPs regularly based on company policy to ensure safe, updated, and effective procedures
  • Remove obsolete SOPs

21 CFR Part 11 requires controlling and approving procedures that impact patient safety and product quality. Good SOPs not only ensure safety and quality but also facilitate internal and external communication, which prevents chaos and provides cross-functional insight within an organisation. Moreover, it can be used as a reference document, a checklist during inspections, and as a proof of sound business activities resulting in high quality and safe medicines and devices. Properly documented and controlled, SOPs can definitely prevent warning letters, legal actions, and recalls.Read More to learn more about Life sciences services.