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FDA 483s and Warning Letters on SOP

Most of  FDA's 483s and Warning Letters observations are deficiencies in Standard Operating Procedures (SOP) at a given organization.

As per 21 CFR requirements-

  • There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess,
  • These written procedures shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit,
  • Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance,
  • Any deviation from the written procedures shall be recorded and justified.

The top 10 reasons for FDA''s 483 related to SOPs include:

1. Procedures not followed

2. Investigations of discrepancies, failures

3. Absence of written procedures

4. Deficiencies in scientifically sound laboratory controls

5. Deficiencies in control procedures to monitor and validate performance

6. Written procedures not established / followed

7. Calibration/inspection / checking not done

8. Deficiencies in training operations, GMPs, written procedures,

9. Deficiencies in cleaning / sanitizing / maintenance

10. SOPs not followed / documented.

Read also: Most Common FDA 483 Observations

How to resolve the issues:

  • Have a procedure in place for determining what procedures or processes need to be documented
  • Understand the compliance regulations well
  • Be knowledgeable about the activity
  • Be knowledgeable with the internal structure
  • Be subject-matter expert who actually performs the work or uses the process
  • Follow a team approach, especially for multi-tasked processes where the experiences of a number of individuals are critical
  • Review and validate the SOPs by one or more individuals with appropriate training and experience with the process
  • Test draft SOPs by individuals other than the original writer before finalizing
  • Have the SOPs approved as per the organization's Quality management plan
  • Review SOPs on a periodic basis
  • When there is a process change, update and re-approve SOPs
  • Maintain a master list of SOPs indicating the SOP number, version number, date of issuance, title, author, status, organizational division, branch, section, and any historical information regarding past versions.

Related: How to Respond to an FDA 483 Observation?

Reasource Person: Prasadhi Shiva

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