Complaints

Question 1

A typical complaints procedure is:

Answer 1

• Receipt of complaint (Request sample if not provided)
  
  • Full record of details – who, what, where and when etc.
  • Assessment – technical/quality or medical
  • Prioritisation based on risk to patient, for example
    ○ Critical, Major ,Minor
    ○ The EU Classification of recalls has helpful definitions
  • Fast track, yes or no? Hold stock, yes or no?
  • Investigation
  • Investigation must investigate/eliminate possibility of counterfeit
  • Conclusion(s)/recommendations – including CAPAs
  • Written company report
  • Reply to complainant
  • Archive
  • Review of complaints file
  • Trending of complaints
    Improvement of the complaints system itself

Question 2

Upon receipt, the person responsible must make a full record of the complaint details. Where possible, these should include:

Answer 2

• Date and time of receipt of complaint
  
  • Name, address and telephone number (of reporter and the actual person who discovered the problem)
  • Date and time of discovering the problem
  • Product details including strength and pack size
  • Nature of the complaint
  • Batch number and expiry date
  • Storage conditions in which the product was kept
  • Date purchased/dispensed
  • Details of pharmacy/wholesaler/hospital etc.

Question 3

Typically, a complaints investigation includes:

Answer 3

• Assessment of risk to the patient/user e.g. with a clinician (who is available to advise in your company? …and can you contact them readily?
  
  • Retrieval of appropriate batch documentation
  • Examination of returned/house samples (Note EC Directive 2003/94 requires that retained samples should be maintained at the disposal of the competent authority)
  • QC analysis of the sample and possibly a particular component raw material
  • Examination/analysis of batches either side
  • Full report of testing performed and results obtained
  • Involvement of the QP during and/or at the end of the investigation