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