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Keep Manufacturing Facility Trustable

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Obaid Ali / Roohi B. Obaid
Obaid Ali / Roohi B. Obaid

Using sound science and risk based approaches is indispensable in prediction and maintaining certainty within emerging regulatory frames.

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Pharmaceutical Manufacturing Facility Keep it Young Regulatory Quality Facility Equipment Process Supply 1 2 3 OARO-10 Sep 2017PDA-2017
Pharmaceutical Manufacturing Facility Keep it Young Regulatory Quality 1 OARO-10 Sep 2017PDA-2017 Review & monitor • Recalls & Lot Acceptance Rates, Trend data & keep an eye on • Increase in Deviations, OOS, CAPAs, complaints, audit observations Trace and track increase in • Change in Process/ equipment/ facility OOS: Out of Specification (Results), CAPA: Corrective & Preventive Action
Pharmaceutical Manufacturing Facility Keep it Young Facility Equipment 2 OARO-10 Sep 2017PDA-2017 WHEN Finishing attracts Parts are not available Technology is obsolete INCREASE Maintenance & Downtime Contamination issues Environmental Monitoring
Pharmaceutical Manufacturing Facility Keep it Young Process Supply 3 OARO-10 Sep 2017PDA-2017 Materials • Supplier is lethargic or losing interest Capacity • Increase in market demand Change • ↓ Process yield • ↑ deviations • ↑ Downtime • ↑ Failures • ↑ Variability • ↑ Rework

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Keep Manufacturing Facility Trustable

  • 1. Pharmaceutical Manufacturing Facility Keep it Young Regulatory Quality Facility Equipment Process Supply 1 2 3 OARO-10 Sep 2017PDA-2017
  • 2. Pharmaceutical Manufacturing Facility Keep it Young Regulatory Quality 1 OARO-10 Sep 2017PDA-2017 Review & monitor • Recalls & Lot Acceptance Rates, Trend data & keep an eye on • Increase in Deviations, OOS, CAPAs, complaints, audit observations Trace and track increase in • Change in Process/ equipment/ facility OOS: Out of Specification (Results), CAPA: Corrective & Preventive Action
  • 3. Pharmaceutical Manufacturing Facility Keep it Young Facility Equipment 2 OARO-10 Sep 2017PDA-2017 WHEN Finishing attracts Parts are not available Technology is obsolete INCREASE Maintenance & Downtime Contamination issues Environmental Monitoring
  • 4. Pharmaceutical Manufacturing Facility Keep it Young Process Supply 3 OARO-10 Sep 2017PDA-2017 Materials • Supplier is lethargic or losing interest Capacity • Increase in market demand Change • ↓ Process yield • ↑ deviations • ↑ Downtime • ↑ Failures • ↑ Variability • ↑ Rework