Compliance Update Allergenic Products Advisory Committee Meeting March 15, 2002 Teddi Lopez DCM/OCBQ Center for Biologics Evaluation and Research.

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Presentation transcript:

Compliance Update Allergenic Products Advisory Committee Meeting March 15, 2002 Teddi Lopez DCM/OCBQ Center for Biologics Evaluation and Research

Enforcement Actions Biological Product Deviation Reports –formerly Errors and Accidents Recalls Issues Leading to Enforcement Actions Forward Thinking

Enforcement Actions Seizures Injunctions Warning Letters License Suspension License Revocation - NOIR Other –Letter after NOIR –Regulatory Meeting with Agency

Enforcement Actions Allergenic Product Manufacturers

Inspection vs. Enforcement FY99

Inspection vs. Enforcement FY00

Inspection vs. Enforcement FY01

FY02 Enforcement Actions If inspection in FY01, but action taken in FY02, inspection counted for FY02 Other inspections completed in FY02 pending classification or review –NAI - No Action Indicated –VAI - Voluntary Action Indicated –OAI - Official Action Indicated - warrant further review

Inspection vs. Enforcement FY02

Biological Product Deviations 21 CFR –Final rule effective May 7, 2001 most firms adopting currently –problems with product in distribution Examples - Precipitates, stability failures

Biologic Product Deviation Reports

Precipitates Accounts for high numbers of BPDs for Allergenic Products Reports may be combined as long as 45 day reporting requirement met Issue discussed between APMA and CBER in October 2000 Interim measures in effect

Recalls Voluntary on part of manufacturer Allergenics - related to labeling

Allergenic Product Recalls

Most Frequent Issues  Enforcement Actions Inadequate Investigations and Corrective and Preventive Actions –failures during production and testing –complaint handling –precipitates (interim plan) Refiltration/Reprocessing/Reworking –lack of validation –sterility assurance concerns

Continued... Container/Closure –integrity –processing Validation –processes, systems, assays –equipment qualification Reserve samples; inspection –

Continued…. Biological Product Deviation Reporting –includes stability failures SOPs Deficiencies Annual Review

Improvement Noted Container Closure Integrity SOPs –in place; still need tweaking Validation –all areas including refiltration, etc. Annual Reviews and Retention Samples BPDR reporting –but still an issue when precipitates not the cause

Forward Thinking Precipitate issue –continue work between manufacturers and CBER with goal of understanding and preventing –may be reported (BPDs) en masse; provided time frame met.

Further Information CBER Home Page – BPD Final Rule – Division of Case Management –