Complaint_Handling_Procedure_FULL_LFG_IFG_July_2025

Complaint Handling Procedure – Local & I-F-G Effective: July 2025.

Overview Procedure for handling product complaints Applies to Locally Finished Goods (L-F-G--) and Imported Finished Goods (I-F-G--) Ensures compliance, accuracy, and timely resolution.

Definitions – Complaints Written or verbal communication Relates to product quality, indicating concern safety, or performance.

Non Medical Complaints Chemical, Packaging or Product bacteriological, or labelling errors or deterioration or physical illegibility malfunction contamination Regulatory noncompliance Visible tampering.

Medical Complaints Patient reaction or injury Product failure or lack of efficacy Failure of pharmacological activity Escalate immediately to Medical Affairs Email: Adcock.Aereports@Ad cock.com.

[Audio] Adverse Events (A-E---) Any unintended medical occurrence Results in death Requires hospitalisation Results in disability Life threatening event Congenital abnormality.

[Audio] DO Requirements – Documentation Use black ink only Ensure writing is clear and legible Complete all sections of the form Submit correct A-I-C-C invoice number Do not use wholesaler invoice number.

[Audio] DO Requirements – Recording Information Record complainant name accurately Forward emailed acknowledgement letters to customer Check lot number, code, defect description Confirm quantity affected and samples returned.

[Audio] Date Format Day in numbers Month in letters Year in numbers Do not erase errors (for example 22) (Aug) (24 or 2024) – strike through, initial and date.

[Audio] Complaint Forms Download from Adcock Ingram Intranet DMD → Group Quality Assurance → Complaint Form Aeroton One form per lot number One form per defect description.

[Audio] Communication Complete A-I-C-C Representative section clearly Copy Sales Manager and Product Manager Copy Complaint Coordinators: Nomazizi Semane, Sinethemba Zwane Copy QA Release Manager: Amina Mbonane – 011494 8586.

[Audio] Submission – General Submit complaints timeously Complaint form and unit must be submitted together Complaints logged only once sample received by QA.

[Audio] Submission – Option 1 (R-M-A--) Customer Service raises R-M-A Logistics collects samples Sales may collect single units if requested QA receives and logs complaint.

[Audio] Submission – Option 2 (Direct) Place unit in plastic bag Staple complaint form to outside of bag Submit form and unit together Leave at Security or QA office.

[Audio] Important Contacts LFG: Sinethemba Zwane – 011494 8801 IFG: Nomazizi Semane – 011494 8744.

[Audio] DO Not Requirements Do not return blood/body fluid contaminated units Take clear photos instead Do not discard defective units Do not use red or blue ink.

[Audio] DO Not – Continued Do not overwrite errors Do not mix forms and units in same bag Do not include multiple lot numbers or defects on one form Do not delay returning complaints.

[Audio] Medical Complaints – Responsibilities Doctor to complete AE forms Ensure information is accurate Obtain device information Sales/Product Rep completes report.

[Audio] Medical Complaints – Communication Inform Medical Affairs within 24 hours Applies to Sales, Marketing, Product Specialists Email: [email protected].

[Audio] Return of Complaint Form & Unit Sales/Product Specialist responsible Complete form with customer where possible Customer to sign form No admissions or conclusions permitted.

[Audio] Depot Returns Pack complaint units securely Label addressee clearly Customer Service/Logistics arrange return Request PO from Product/Sales Manager.

[Audio] Ordering or processing errors Shipping damage Temperature excursions Product preference opinions Requests for product change Exclusions – Not Product Complaints.

[Audio] Imported Finished Goods (I-F-G--) Same complaint process as local products Photos must be clear and legible Suppliers may request physical units Contaminated units – photos only.

[Audio] Important I-F-G Notes During Use means used on patient Insufficient info may lead to closure Suppliers do not credit unvalidated complaints Liaise with Product/Sales Manager if credit required.

[Audio] End of Procedure Thank you Ensure compliance with this procedure at all times.