The QMN Weekly Bulletin
Pharmaceuticals / GMPs

Warning Letters, FDA Guidances Feature Tips for Drafting SOPs

Jan. 15, 2016

Effective standard operating procedures are central to any life sciences company, but the FDA’s pharmaceutical regulations don’t mention SOPs specifically. Instead, regulations refer to “procedures” related to quality control and require them to be maintained in writing.

For example, pharma companies need to maintain SOPs that address buildings and facilities, equipment, control of components and drug product containers and closures, and production and process controls.

Written procedures need to be drafted, reviewed and approved by the appropriate business unit, and then must be signed off on by the quality control unit. Any deviations from these written procedures must be documented and justified, says John Avellanet, managing director and principal of consultancy firm Cerulean Associates.

A good SOP needs to describe who is involved, as well as who has ultimate ownership of that process. It will describe the action steps, including when, where and how those steps are carried out. It also will describe the end result of a process and how compliance is verified.

The specific requirements that have informed the SOP should be referenced, such as whether those are regulatory requirements or clinical best practices.

What SOPs Do You Need?

Regulations and guidance are good places to start when deciding which processes need to be recorded as SOPs. FDA also released in 2011 a list of SOPs organizations should maintain to be in compliance, which include:

  • Responsibilities of the quality control unit;
  • Cleaning and maintenance of equipment;
  • Production and process control;
  • Sampling and testing of in-process materials and drug products;
  • Prevention of objectionable microorganisms and microbiological contamination in drug products not required to be sterile;
  • Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials and labeling control;
  • Warehousing and distribution of drug products;
  • Laboratory controls, testing and release for distribution;
  • Stability testing;
  • Notification of responsible officials of investigations, recalls, reports of inspectional observations and any GMP-related actions; and
  • Written and oral complaint handling, investigations and reviews.

That list is a good starting place for drug companies, but the FDA expects companies to maintain many other SOPs, such as corrective and preventive actions, Avellanet said.

Inadequate SOPs rank among the most frequently cited Form 483 observations. Our new management report Writing SOP’s: Best Practices for Life Science Companies will teach you the practical techniques you need for crafting well-written, flexible and compliant SOPs.