規制当局が要求する監査について

筆者がコンサルテーションや外部監査、模擬査察などを実施する中、監査に対する誤解が多いように感じている。

監査は、「間違いを見つけること」ではない。「間違いがないことを確認する」ことである。
間違いを見つけるのはQCの仕事である。また品質を保証するのはQAの仕事である。
では、いったい監査の目的は何であろうか。

例えば、PIC/S GMPの第9章には以下のような要件が記載されている。
「それらが品質保証の原則に適合しているか検証するため、あらかじめ定められたプログラムに従った間隔にて監査されること。」
また、21 CFR Part 820 QSRの820.22　品質監査には以下の記載がある。
「各製造業者は、品質監査の手順を確立し、品質システムが品質システム要求を遵守していることを確実にするため、および品質システムの有効性を判定するために監査を実施すること。」
いずれも間違いを発見せよとは記載されていない。
監査では、品質システム（QMS）が、規制要件を満たしているか、また品質システム（QMS）の有効性を判定することがその目的である。

どのような企業がFDA等の規制当局に好印象を与えるかというと、
・FDA査察官と同様のスキル・洞察力をもった監査員が存在し、内部監査（Self Inspection）が適切に実施されている。
・内部監査の指摘に対して、CAPAを実行し、常に改善を図っている。
・品質システムが有効に機能しており、その証拠が揃っている。
上記を満たす企業である。

医薬品企業・医療機器企業がグローバル化を促進する中、FDAをはじめ海外の規制当局の査察を受ける機会が多くなった。
一方で規制当局は、サプライチェーンがグローバル化していることに伴い、海外査察の回数を増やしている。
しかしながら、査察にかけることができるリソースは限られているため、効率的な査察手法が必要である。
従来の査察では、査察官から指摘された事項を是正しておけば、容認されてきた。
しかしである。わずか数日の査察（FDAによる査察は、日本においては4日間）で査察官が発見することができる問題点・リスクは数が限られている。
したがって、査察官が発見したエラー（リスク）に対して是正を行えば自国民の安全が守られるということにはならない。
そこでFDAなどの査察では、エラー（リスク）を発見する査察手法から、当該企業が経営者のガバナンス（統治）のもと『品質システム（品質システム）』を確立しているかどうかを調査するといった手法に切り替えているのである。

「自己点検」は、英語では「Self Inspection」を訳したものであるが、この訳には問題がある。本来は「自己査察」または「内部監査」である。
lこれまでの製薬・医療機器企業は、当局の指摘に従って改善していれば、許可が与えられた。しかしながら、当局の指摘を行う能力や、時間に依存する。
したがって、当局の査察（Authority Inspection）ではなく、自社の監査（Self Inspection）により、リスクを受容可能まで低減することが重要である。
なお、「自己点検」は、内部監査、外部監査、定期レビュ、マネージメントレビュなどからなる。

また、監査を実施し、指摘事項をまとめ、監査報告書を作成することで監査を終了しているケースをしばしば見かける。
そうではない。監査は、指摘に対して被監査部門が是正処置を行い、その結果をフォローアップ（再監査）することによって確認することによって終了するのである。

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  324. NERVOVIVE REVIEWS

  325. Alphabites

  326. Fitspresso reviews

  327. NERVOVIVE REVIEW

  328. Fitspresso reviews

  329. FREE SUGAR PRO

  330. Alpha bites review

  331. Lipozem

  332. Lipozem

  333. LipoSlim

  334. Alpha bites

  335. Lipo Slim review

  336. Alphabites

  337. Alphabites review

  338. Alphabites

  339. Femipro

  340. Femipro review

  341. MANNA FLUX

  342. MANNA FLUX

  343. Kerassentials review

  344. Alphabites reviews

  345. Alphabites

  346. Boostaro

  347. Boostaro review

  348. TONIC GREENS REVIEW

  349. Dentavim

  350. LEANBIOME

  351. how does Booster XT work

  352. Booster XT review

  353. Booster XT side effects

  354. Alphabites reviews

  355. Alphabites reviews

  356. Alpha bites

  357. Alpha bites reviews

  358. Booster XT review

  359. NEUROQUIET REVIEWS

  360. Booster XT side effects

  361. NEUROQUIET REVIEWS

  362. NEUROQUIET REVIEWS

  363. Alphabites

  364. Alpha bites

  365. Fitspresso review

  366. Fitspresso reviews

  367. Mitolyn

  368. Lipozem reviews

  369. Lipozem

  370. Mitolyn review

  371. Mitolyn review

  372. Mitolyn

  373. MITOLYN REVIEWS

  374. MITOLYN REVIEWS

  375. Mitolyn

  376. Mitolyn reviews

  377. Mitolyn

  378. Mitolyn

  379. Mitolyn

  380. Booster XT results

  381. Booster XT

  382. Lottery defeater

  383. Lottery defeater system reviews

  384. Fitspresso reviews

  385. Fitspresso reviews

  386. Alphabites reviews

  387. Alphabites

  388. Alpha bites review

  389. Alpha bites

  390. Nicoya PuraTea

  391. Nicoya PuraTea reviews

  392. Booster XT ingredients

  393. Mitolyn review

  394. Mitolyn review

  395. Mitolyn

  396. Mitolyn review

  397. Mitolyn

  398. Mitolyn reviews

  399. Mitolyn

  400. Mitolyn

  401. Mitolyn review

  402. Mitolyn

  403. Mitolyn review

  404. Mitolyn

  405. Mitolyn reviews

  406. Mitolyn reviews

  407. Mitolyn reviews

  408. Mitolyn reviews

  409. ALPHA BITES

  410. MITOLYN REVIEW

  411. ALHA BITES REVIEW

  412. Lipozem

  413. Lipozem

  414. PROSTAZEN REVIEWS

  415. PROSTAZEN REVIEW

  416. LIPOZEM REVIEW

  417. SERENAFLOW REVIEW

  418. Mitolyn reviews

  419. MITOLYN REVIEW

  420. Mitolyn

  421. Mitolyn review

  422. Mitolyn review

  423. Fitspresso

  424. Fitspresso review

  425. Fitspresso reviews

  426. Fitspresso reviews

  427. Kerassentials reviews

  428. MITOLYN REVIWS

  429. TRIBALFORCE

  430. ALPHA BITES REVIEWS

  431. Mitolyn

  432. ALPHA BITES REVIEWS

  433. Mitolyn reviews

  434. Mitolyn review

  435. Mitolyn reviews

  436. Mitolyn review

  437. Mitolyn review

  438. MITOLYN

  439. NAGANO TONIC REVIEWS

  440. Neuroquiet

  441. Mitolyn review

  442. Mitolyn reviews

  443. Mitolyn review

  444. NEOTONICS REVIEWS

  445. SUGAR DEFENDER REVIEWS

  446. Mitolyn review

  447. Mitolyn

  448. Mitolyn

  449. PROSTAZEN REVIEWS

  450. PROSTAZEN REVIEW

  451. PROSTAZEN REVIEW

  452. Nagano Lean Body Tonic

  453. PROSTAZEN

  454. Mitolyn

  455. Leanbiome review

  456. Mitolyn

  457. TRIBAL FORCE X

  458. TONIC GREENS

  459. Mitolyn review

  460. TRIBALFORCE

  461. ProvaDent

  462. TONIC GREENS

  463. Mitolyn reviews

  464. TRIBAL FORCE X

  465. MITOLYN REVIEW

  466. MITOLYN REVIEW

  467. LeanBiome

  468. Mitolyn

  469. LeanBiome review

  470. Mitolyn review

  471. LOTTERY DEFEATER SOFTWARE

  472. LOTTERY DEFEATER

  473. Mitolyn

  474. LOTTERY DEFEATER

  475. Mitolyn

  476. Mitolyn reviews

  477. PROVADENT

  478. ALPHA BITES

  479. Mitolyn reviews

  480. PROVADENT

  481. Mitolyn

  482. Mitolyn

  483. Mitolyn review

  484. Mitolyn reviews

  485. Mitolyn reviews

  486. Mitolyn review

  487. Mitolyn reviews

  488. Mitolyn

  489. Mitolyn

  490. Mitolyn reviews

  491. Mitolyn

  492. Mitolyn review

  493. Mitolyn reviews

  494. Mitolyn review

  495. Mitolyn reviews

  496. Mitolyn reviews

  497. Mitolyn reviews

  498. Mitolyn

  499. MITOLYN REVIEW

  500. MITOLYN

  501. MITOLYN REVIEW

  502. MITOLYN REVIEWS

  503. SIGHT CARE

  504. SIGHT CARE REVIEWS

  505. MITOLYN REVIEWS

  506. MITOLYN REVIEWS

  507. LEANBIOME

  508. MITOLYN REVIEWS

  509. LOTTERY DEFEATER SOFTWARE

  510. ERECPRIME

  511. LOTTERY DEFEATER REVIEWS

  512. LOTTERY DEFEATER REVIEWS

  513. LOTTERY DEFEATER SOFTWARE

  514. LOTTERY DEFEATER REVIEWS

  515. Mitolyn

  516. Tonic greens

  517. Tonic greens

  518. Quietum plus review

  519. Quietum plus review

  520. Nagano Lean Body Tonic Review

  521. Nagano Lean Body Tonic Review

  522. Mitolyn

  523. ALPHA BITES

  524. MITOLYN REVIEWS

  525. LOTTERY DEFEATER SOFTWARE

  526. MITOLYN REVIEWS

  527. MITOLYN REVIEW

  528. MITOLYN REVIEWS

  529. LOTTERY DEFEATER REVIEWS

  530. LOTTERY DEFEATER SOFTWARE

  531. DENTICORE REVIEW

  532. PROSTAVIVE REVIEWS

  533. TONIC GREENS REVIEWS

  534. MITOLYN REVIEW

  535. MITOLYN REVIEW

  536. MITOLYN REVIEWS

  537. Mytolyn review

  538. MITOLYN REVIEW

  539. MITOLYN

  540. MITOLYN REVIEW

  541. MITOLYN REVIEWS

  542. MITOLYN REVIEW

  543. Billionaire Brain Wave review

  544. MITOLYN

  545. Mitolyn review

  546. MITOLYN

  547. MITOLYN REVIEW

  548. Mitolyn

  549. MITOLYN REVIEW

  550. MITOLYN

  551. Alpha Bites

  552. MITOLYN REVIEWS

  553. MITOLYN

  554. MITOLYN

  555. MITOLYN

  556. MITOLYN

  557. MITOLYN REVIEWS

  558. MITOLYN REVIEWS

  559. SOULMATE STORY REVIEWS

  560. Lottery Defeater

  561. PRODENTIM REVIEW

  562. Lottery Defeater Review

  563. NATURAL MOUNJARO RECIPE

  564. MITOLYN REVIEWS

  565. NATURAL MOUNJARO RECIPE

  566. Lottery Defeater

  567. NATURAL MOUNJARO DRINK

  568. Boostaro

  569. NATURAL MOUNJARO RECIPE

  570. NATURAL MOUNJARO DRINK

  571. Boostaro

  572. NATURAL MOUNJARO 4 INGREDIENTS

  573. MITOLYN WEIGHT LOSS

  574. NATURAL MOUNJARO 4 INGREDIENTS

  575. Pronerve6

  576. Billionaire Brain Wave

  577. NATURAL MOUNJARO 4 INGREDIENTS

  578. Billionaire Brain Wave

  579. MITOLYN WEIGHT LOSS

  580. NATURAL MOUNJARO RECIPE

  581. MITOLYN

  582. Billionaire Brain Wave Review

  583. MITOLYN REVIEW

  584. MITOLYN REVIEWS

  585. MITOLYN REVIEW

  586. MITOLYN

  587. MITOLYN REVIEW

  588. MITOLYN

  589. MITOLYN

  590. MITOLYN WEIGHT LOSS

  591. MITOLYN REVIEW

  592. MITOLYN

  593. MITOLYN REVIEW

  594. Mitolyn review

  595. MITOLYN REVIEWS

  596. MITOLYN REVIEW

  597. Mitolyn review

  598. MITOLYN

  599. MITOLYN REVIEWS

  600. PRODENTIM REVIEWS

  601. Kerassentials

  602. MITOLYN REVIEW

  603. Boostaro

  604. NATURAL MOUNJARO RECIPE

  605. Boostaro

  606. MITOLYN REVIEWS

  607. Lottery Defeater

  608. NATURAL MOUNJARO RECIPE

  609. Lottery Defeater Review

  610. MITOLYN REVIEWS

  611. SUGAR DEFENDER

  612. MITOLYN

  613. Leanbiome review

  614. MITOLYN REVIEWS

  615. Leanbiome review

  616. PRODENTIM REVIEWS

  617. Mitolyn

  618. MITOLYN REVIEWS

  619. PRODENTIM REVIEWS

  620. NAGANO TONIC

  621. MITOLYN

  622. NAGANO LEAN BODY TONIC

  623. MITOLYN REVIEWS

  624. PRODENTIM

  625. NAGANO TONIC

  626. MITOLYN REVIEWS

  627. NAGANO LEAN BODY TONIC

  628. MITOLYN

  629. NATURAL MOUNJARO RECIPE

  630. NATURAL MOUNJARO RECIPE

  631. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  632. POTENT STREAM

  633. NATURAL MOUNJARO RECIPE

  634. POTENTSTREAM

  635. NATURAL MOUNJARO RECIPE

  636. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  637. NATURAL MOUNJARO

  638. POTENT STREAM

  639. NATURAL MOUNJARO RECIPE

  640. NATURAL MOUNJARO RECIPE

  641. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  642. NATURAL MOUNJARO

  643. NATURAL MOUNJARO

  644. NATURAL MOUNJARO

  645. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  646. POTENT STREAM REVIEWS

  647. NATURAL MOUNJARO RECIPE

  648. NATURAL MOUNJARO RECIPE

  649. POTENT STREAM

  650. NATURAL MOUNJARO

  651. POTENT STREAM

  652. NATURAL MOUNJARO RECIPE

  653. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  654. POTENTSTREAM

  655. NATURAL MOUNJARO RECIPE

  656. MITOLYN REVIEWS

  657. PROSTAZEN

  658. MITOLYN REVIEWS

  659. MITOLYN REVIEW

  660. MITOLYN REVIEW

  661. MITOLYN REVIEW

  662. PROSTAZEN REVIEWS

  663. MITOLYN REVIEW

  664. PROSTAZEN REVIEW

  665. MITOLYN REVIEWS

  666. MITOLYN

  667. MITOLYN REVIEWS

  668. PROSTAZEN

  669. MITOLYN REVIEWS

  670. MITOLYN

  671. PROSTAZEN REVIEWS

  672. MITOLYN REVIEWS

  673. NATURAL MOUNJARO RECIPE

  674. PROSTAZEN

  675. NATURAL MOUNJARO RECIPE

  676. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  677. PROSTAZEN

  678. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  679. PROSTAZEN

  680. NATURAL MOUNJARO RECIPE

  681. PROSTAZEN REVIEWS

  682. PROSTAZEN

  683. PROSTAZEN REVIEW

  684. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  685. NATURAL MOUNJARO RECIPE 4 INGREDIENTS

  686. NATURAL MOUNJARO

  687. NATURAL MOUNJARO RECIPE

  688. Herpafend

  689. MITOLYN REVIEW

  690. Mitolyn review

  691. MITOLYN REVIEW

  692. NITRIC BOOST ULTRA

  693. MITOLYN

  694. MITOLYN

  695. MITOLYN REVIEW

  696. NERVE FRESH REVIEW

  697. MITOLYN REVIEWS

  698. NERVE FRESH REVIEW

  699. MITOLYN

  700. NERVE FRESH REVIEWS

  701. MITOLYN REVIEWS

  702. MITOLYN REVIEW

  703. NERVE FRESH

  704. MITOLYN

  705. NERVE FRESH

  706. MITOLYN

  707. MITOLYN

  708. NERVE FRESH

  709. NERVE FRESH REVIEWS

  710. MITOLYN

  711. NATURAL MOUNJARO RECIPE

  712. MITOLYN REVIEWS

  713. MITOLYN

  714. Mitolyn review

  715. MITOLYN REVIEW

  716. Tea burn review

  717. MITOLYN REVIEWS

  718. KERASSENTIALS REVIEWS

  719. MITOLYN REVIEW

  720. MITOLYN REVIEW

  721. MITOLYN

  722. MITOLYN

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