FDAの海外査察の状況を保健福祉省（HHS）が批判

アメリカの保健福祉省（HHS）の監察総監室（Office of Inspector General, OIG）がFDAの医薬品に関する外国のfor cause査察に関する監査を行い、FDAの不備を批判する報告書を発出しました。

FDAの上位組織であるHHSがFDAを監査して、FDAに対して指摘を出したというものです。

OIGによるFDAの監査

OIGは、FDAが実施した以下の医薬品に関する外国のfor cause査察についてレビュし、監査を行いました。

  • 2016年1月1日～2017年3月31日に実施した64件の査察
  • 2018年1月1日～2019年3月31日に実施した68件の査察

監査の結果、OIGは以下の不備を発見しました。

  1. FDAは、外国のfor cause査察に関するポリシーと手順に必ずしも従っていなかった
  2. FDAは、すべての主任査察官（lead investigator）が査察を実施する前に必要なトレーニングを完了したことを裏付ける文書を提供できなかった

OIGによる、FDAへの改善推奨

OIGはFDAに対して6つのRecommendationを発出し、FDAは改善に取り組む旨を述べています。

  1. FDA should identify and implement additional ways to improve the timeliness of its foreign for-cause inspection process.
    (FDAは、外国のFor-cause査察プロセスのタイムリネスを改善するための追加の方法を特定し、実施する必要がある。)
  2. FDA should consider streamlining the process for writing and reviewing EIRs to minimize potential delays due to unexpected events.
    （FDAは、予期しないイベントによる潜在的な遅延を最小限に抑えるために、EIRの作成とレビューのプロセスを合理化することを検討する必要がある。）
  3. FDA should conduct an analysis of the workloards of indivisuals responsible for determining final classification, issuing warning letters, holding regulatory meetings, and address any potential issues identified by this analysis.
    （FDAは、査察の最終のクラシフィケーションの決定、Warning Letterの発行、レギュラトリーミーティングの開催を担当する個人の作業負荷の分析を実施し、この分析によって特定された潜在的な問題に対処する必要がある。）
  4. FDA should implement poliies and procedures to ensure that lead investigators assigned to inspections have completed the Level 1 Investigator Certification Process.
    （FDAは、査察にアサインされた主任査察官がレベル1の査察官認定プロセスを確実に完了するためのポリシーと手順を実施する必要がある。）
  5. FDA should ensure that supervisiors review investigators’ qualifications and document that they meet applicable training requirements when the investigator training records do not exist.
    （FDAは、監督者が査察官の資格を確認し、査察官のトレーニング記録が存在しない場合に、それらが該当するトレーニング要件を満たしていることを文書化することを保証する必要がある。）
  6. FDA should review the training records of the lead invstigators that were outside the scope of the audit to verify that the documentation supports either that the investigators completed the required training courses, Level 1 Perdformance Audit, and Level 1 Investigator Certification, of that the investigators are recommended “experened investigators” by supervisors and have completed training courses equivalent to the current required training courses.
    （FDAは、今回の監査の対象外であった主任査察官のトレーニング記録をレビューして、査察官が必要なトレーニングコース、レベル1パフォーマンス監査、およびレベル1査察官認定を完了しているか、査察官が監督者から「経験豊富な査察官」として推薦され、現在必要なトレーニングコースと同等のトレーニングコースを修了していることを文書がサポートしていることを確認する必要がある。）

HHSによるFDA監査報告書

報告書を閲覧したい方はこちらからどうぞ

HHSの指摘の1つである「主任査察官のトレーニング記録が提出できなかった」という、FDAが査察で頻繁に出す指摘をFDA自体が受けてしまったというのがなんとも皮肉ですね。
アメリカでは当局自体も監査対象となって是正がなされる点が良い仕組みとなっているように思います。

https://www.youtube.com/watch?v=zIHXobIP_vo

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS（手順書）ひな形　医薬品関連” ]

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  467. Neotonics review

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  475. LOTTERY DEFEATER

  476. Lottery defeater system review

  477. SUGAR DEFENDER REVIEW

  478. PURDENTIX REVIEWS

  479. The genius wave

  480. LOTTERY DEFEATER

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  483. The genius wave reviews

  484. Lottery defeater review

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  486. sugar defender 24

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  489. Dentavim

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  491. PLANTSULIN REVIEW

  492. Lipo slend reviews

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  495. GLUCO FREEDOM

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  497. LIPOZEM

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  501. Lottery defeater system reviews

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  504. Tonic Greens

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  508. Pineal XT review

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  515. Lottery defeater system

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  523. Lipozem review

  524. PROSTAVIVE

  525. Boostaro reviews

  526. Alphabites review

  527. Quietum Plus review

  528. nitric boost real reviews

  529. The genius wave review

  530. Alpha bites reviews

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  534. Alpha bites review

  535. ALPHA BITES

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  537. nitric boost supplement

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  544. NAGANO LEAN BODY TONIC

  545. LOTTERY DEFEATER

  546. ALPHA BITES REVIEWS

  547. Alpha bites

  548. Fitspresso

  549. Alphabites

  550. Alpha bites reviews

  551. LOTTERY DEFEATER

  552. BOOSTARO REVIEWS

  553. FITSPRESSO REVIEWS

  554. LOTTERY DEFEATER

  555. BOOSTARO

  556. NAGANO TONIC REVIEWS

  557. ALPHA BITES REVIEW

  558. Lottery defeater system reviews

  559. Fitspresso reviews

  560. Alpha bites reviews

  561. TURMERIC HACK

  562. LIPOZEM REVIEW

  563. PURAVIVE REVIEW

  564. FITSPRESSO REVIEWS

  565. Lipo Slim reviews

  566. PRONAIL COMPLEX REVIEWS

  567. Lipo Slim review

  568. NERVOVIVE REVIEWS

  569. Alphabites review

  570. Fitspresso reviews

  571. Alphabites

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  573. Alphabites review

  574. Lipozem reviews

  575. LipoSlim

  576. Alpha bites reviews

  577. Lipo Slim reviews

  578. Alpha bites reviews

  579. Alpha bites

  580. Femi pro reviews

  581. MANNAFLUX

  582. Alphabites

  583. Boostaro

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  585. Dentavim

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  588. buy Booster XT

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  590. Alphabites reviews

  591. Alphabites

  592. Booster XT scam or legit

  593. NEUROQUIET REVIEWS

  594. Alphabites review

  595. Fitspresso review

  596. Mitolyn

  597. Lipozem review

  598. Mitolyn review

  599. Mitolyn review

  600. MITOLYN REVIEWS

  601. Mitolyn review

  602. Mitolyn

  603. Mitolyn

  604. where to buy Booster XT

  605. Lottery defeater review

  606. Fitspresso

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  608. Alphabites

  609. Nicoya PuraTea

  610. where to buy Booster XT

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  612. Mitolyn

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  614. Mitolyn reviews

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  618. Mitolyn reviews

  619. ALHA BITES REVIEW

  620. MITOLYN

  621. ALHA BITES REVIEWS

  622. Lipozem reviews

  623. PROSTAZEN REVIEWS

  624. PROSTAZEN REVIEW

  625. LIPOZEM REVIEWS

  626. Mitolyn review

  627. MITOLYN

  628. Mitolyn review

  629. Fitspresso review

  630. Fitspresso review

  631. Kerassentials reviews

  632. MITOLYN REVIW

  633. ALPHA BITES REVIEWS

  634. Mitolyn reviews

  635. Mitolyn review

  636. Mitolyn

  637. MITOLYN REVIWS

  638. NAGANO TONIC

  639. Neuroquiet

  640. Mitolyn

  641. Mitolyn

  642. SUGAR DEFENDER

  643. Mitolyn

  644. Mitolyn review

  645. PROSTAZEN REVIEWS

  646. PROSTAZEN REVIEWS

  647. Nagano Lean Body Tonic

  648. Leanbiome review

  649. TRIBAL FORCE X REVIEW

  650. TONIC GREENS

  651. Mitolyn review

  652. ProvaDent

  653. TRIBAL FORCE X

  654. MITOLYN

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  656. MITOLYN REVIEWS

  657. LeanBiome review

  658. Mitolyn

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  660. LOTTERY DEFEATER REVIEWS

  661. Mitolyn

  662. Lottery Defeater review

  663. ALPHA BITES REVIEW

  664. Mitolyn reviews

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  666. Mitolyn review

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  677. MITOLYN REVIEWS

  678. MITOLYN REVIEWS

  679. MITOLYN REVIEW

  680. LEANBIOME REVIEWS

  681. LOTTERY DEFEATER SOFTWARE

  682. MITOLYN REVIEW

  683. ERECPRIME REVIEWS

  684. PROSTAZEN REVIEWS

  685. Mitolyn review

  686. Tonic greens

  687. Nagano Lean Body Tonic

  688. Nagano Lean Body Tonic Review

  689. Mitolyn review

  690. LOTTERY DEFEATER REVIEWS

  691. ALPHA BITES

  692. AIZEN POWER

  693. LOTTERY DEFEATER REVIEWS

  694. LOTTERY DEFEATER

  695. MITOLYN REVIEWS

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  698. DENTICORE REVIEW

  699. DENTICORE

  700. PROSTAVIVE REVIEW

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  702. TONIC GREENS REVIEWS

  703. MITOLYN REVIEW

  704. MITOLYN REVIEW

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  712. Billionaire Brain Wave

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  717. Alpha Bites Review

  718. MITOLYN REVIEW

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  740. NATURAL MOUNJARO DRINK

  741. Billionaire Brain Wave Review

  742. NATURAL MOUNJARO RECIPE

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  757. MITOLYN REVIEWS

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  761. Boostaro review

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  770. SUGAR DEFENDER

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