PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Complaints and Recall

PIC/S Guide to Good Manufacturing Practice for Medicinal Products PICSGMP-8: Chapter 8: Complaints, Quality Defects, Product Recall

Per PIC/S GMP Chapter 8: complaints + recall. Requirements include (a) operate Complaints handling including receiving + recording + investigation + response + trending + (b) operate Quality Defect investigation including root cause analysis + impact assessment + CAPA (Corrective and Preventive Actions) + (c) implement Product Recall capability including notification of regulators + customers + retrieval + reconciliation + (d) maintain mock recall exercises + (e) integrate with broader pharmacovigilance + post-marketing surveillance + (f) maintain documentation supporting regulator inspection + (g) cooperate with PIC/S inspectorate + local regulators.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 12 controls across 7 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • AS9100D-5.1 Leadership and Commitment
  • AS9100D-8.5 Production and Service Provision
  • FDBR-705 Consumer Rights (§501.705)
  • FDBR-ConsumerRights Consumer Rights (Fla. Stat. 501.705, 501.706, 501.707)
  • CPSC-CS.4 Vulnerability Disclosure
  • CPSC-PM.2 Product Recall Procedures

ISO 26000:2010 · 1 control

  • ISO-26000-6.7 Consumer issues
  • PNGCYBER-3 NICTA Oversight and Computer Emergency Response Team (CERT) Coordination
  • 2.5.4 Product Sampling, Inspection, and Analysis
  • USMCADIGITAL-2 Personal Information Protection and Consumer Protection

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Query this from an agent

The graph holds this control, the 12 it maps to, and the evidence behind each claim, over MCP and REST.