Vector Control Inspection Update - WHO · Copenhagen, Denmark 2 – 5 December 2019 1 Vector...

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

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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

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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

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Inspection process (continued)

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

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2018 November 2019

Total number of Inspections

14 13

LLINs 13 12

Other formulations 1 1

Comparison of inspections conducted in 2018 and 2019

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Category Number

Critical 4

Major 48

Minor 40

Non conformances identified in 2019

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

Countries Vs Inspections

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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

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• Before After

Calibration non-conformance

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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)

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Traceability

Traceability at different production stages

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Unlabeled solutions Labeled solutions

Labelling of lab solutions Non conformance

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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.

Examples of commonly cited non conformances (Continued)

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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.

Examples of commonly cited non conformances (Continued)

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Locked excel sheet

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• 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

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Thank you Merci

Questions?

The end

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