Vector Control Inspection Update - WHO · Copenhagen, Denmark 2 – 5 December 2019 1 Vector Control Inspection Update Conrad Mark, Technical officer, WHO Prequalification Team

1Copenhagen, Denmark 2 – 5 December 2019

Vector Control Inspection Update

Conrad Mark, Technical officer, WHO Prequalification Team

Overview

• Why conduct inspections• Inspection process• Trends• Commonly cited nonconformances

Copenhagen, Denmark 2 – 5 December 2019 2

Why inspect

• Demonstrate ability to meet specified ISO 9001:2015 and WHO requirements

• Assess the facility’s ability to manufacture vector control products that consistently meet the set specifications and applicable requirements


Inspection process

• Communication and confirmation of inspection date• Communication of tentative inspection plan• Inspection of facility

• Manufacturing process• Material handling• Personnel • Process and testing controls• Procedures, records and other relevant documented information• Validation (where applicable)• Equipment and calibration documents


Inspection process (continued)

• Writing and communication of the inspection report • Submission of corrections and corrective actions (CAPA)• Review of CAPA• Closure of inspection


2018 November 2019

Total number of Inspections

14 13

LLINs 13 12

Other formulations 1 1

Comparison of inspections conducted in 2018 and 2019


Category Number

Critical 4

Major 48

Minor 40

Non conformances identified in 2019


Country Number of inspections (2019)China 9India 2Pakistan 1Rwanda 1

Countries Vs Inspections


Clause 7.1.5.2 – Measurement traceability • Several equipment was not calibrated

◦ the measuring tape used to determine the length that is to be cut◦ the balances used for weighing of raw materials◦ the standard weights used for calibration of the balance in the

laboratory.• Calibration records not retained.

Examples of commonly cited non conformances


• Before After

Calibration non-conformance


Clause 8.5.2 – Identification and traceability • Batch numbers of the active and inactive raw materials

used in production not recorded in the batch manufacturing records.

• Inadequate identification and traceability of the fabric at different production stages.

• Sampled raw materials were not adequately identified. • Freshly prepared laboratory solutions not labelled

Examples of commonly cited non conformances (Continued)


Traceability

Traceability at different production stages


Unlabeled solutions Labeled solutions

Labelling of lab solutions Non conformance


Clause 8.6 Product release• No evidence that the testing results for the working liquid

were reviewed and released by the Head, technical department

• Product release did not take into account:o review of the production processo all related production records.



Clause 8.1 – Operational planning and control• Inadequate control of labels and printed polybags in that:

◦ no reconciliation was performed to ascertain:- number of labels issued to production- number being used- remaining balance

• Excel sheets used for calculation of the API content i.e. deltamethrin◦ not locked to safe guard the formulas from unintentional changes

or alterations.



Locked excel sheet


• Corrections refer to:◦ immediate actions taken to address the non conformance

• Corrective actions refer to:◦ actions taken to address the root cause of the non conformance

• It is important that identification of the root cause is well done and documented

• Correction and Corrective Action plans received so far shown improvements and willingness by the facilities to improve their QMS and comply with the WHO and ISO 9001 requirements

CAPA response: Corrections and corrective actions


Thank you Merci

Questions?

The end


Documents

Vector Control Inspection Update - WHO · Copenhagen, Denmark 2 – 5 December 2019 1 Vector Control Inspection Update Conrad Mark, Technical officer, WHO Prequalification Team