備檢

評增組為規檢之備、含文、人備、後勤、應計。

用

• 規檢已告或預→用
• 期察檢備→用
• 末檢以來新系/程已實→用
• 業勢（警函、483）顯新聚→用
• 大審發恐引規注後→用

入

• 必：檢機（FDA、EMA、MHRA 或他）
• 必：預檢範（資整、CSV、GMP、GLP、GCP）
• 必：循架與系錄
• 可：前檢報與見
• 可：近業警函與 483 題
• 可：開 CAPA 與審發

行

一：析機特聚

研檢機今先：

# Inspection Focus Area Analysis
## Document ID: IFA-[SITE]-[YYYY]-[NNN]

### FDA Current Focus Areas
| Focus Area | Regulatory Basis | Recent 483 Trends | Risk to This Site |
|-----------|-----------------|-------------------|-------------------|
| Data integrity | 21 CFR Part 11, CGMP | #1 cited observation in drug 483s since 2016 | [H/M/L] |
| Audit trail | 21 CFR 11.10(e) | Disabled/incomplete audit trails | [H/M/L] |
| Electronic signatures | 21 CFR 11.50-11.300 | Missing manifestation, shared accounts | [H/M/L] |
| Computer system validation | GAMP 5, FDA guidance | Inadequate validation of Category 4/5 systems | [H/M/L] |
| Change control | ICH Q10 | Undocumented or retrospective changes | [H/M/L] |
| Laboratory controls | 21 CFR 211.160-211.176 | OOS investigation, test repetition | [H/M/L] |

### EMA/MHRA-Specific Considerations
| Area | EU Annex 11 Reference | Focus | Risk to This Site |
|------|----------------------|-------|-------------------|
| Computerized system validation | §4, §5 | Risk-based validation, supplier assessment | [H/M/L] |
| Operational phase | §6-§13 | Security, audit trail, backup, business continuity | [H/M/L] |
| Cloud and outsourced systems | §3.4 | Service level agreements, data sovereignty | [H/M/L] |
| Data governance | MHRA DI guidance | ALCOA+, culture of integrity | [H/M/L] |

得：檢機特之檢聚險評析。 敗：近 483/警函資未得→詢 FDA 警函庫、EMA 檢報或業刊為今勢。

二：行備自察

各聚評址：

# Inspection Readiness Assessment
## Document ID: IRA-[SITE]-[YYYY]-[NNN]

### Readiness Scoring
| Focus Area | Weight | Current State | Score (1-5) | Gap | Remediation Priority |
|-----------|--------|--------------|-------------|-----|---------------------|
| Data integrity controls | High | [Description of current state] | [1-5] | [Gap description] | [Critical/High/Medium/Low] |
| Validation documentation | High | [Description] | [1-5] | [Gap] | [Priority] |
| Audit trail compliance | High | [Description] | [1-5] | [Gap] | [Priority] |
| Electronic signatures | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| Change control | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| Training records | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| SOPs (current, approved) | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| CAPA management | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| Vendor qualification | Low | [Description] | [1-5] | [Gap] | [Priority] |
| Periodic review | Low | [Description] | [1-5] | [Gap] | [Priority] |

Score: 1 = Critical gaps, 5 = Fully compliant
Overall readiness score: [Sum / Max] = [X]%

### Remediation Plan
| Gap ID | Description | Owner | Action | Deadline | Status |
|--------|------------|-------|--------|----------|--------|
| GAP-001 | [Gap] | [Name] | [Remediation action] | [Date] | [Open/In Progress/Closed] |

得：量化備察含序補行。 敗：總備 <70%→計求檢延（若許）、行急補。

三：備文包

組文為檢備包：

# Inspection Document Bundles

### Bundle 1: Validation Pack (per system)
- [ ] Current validation status summary (one-page per system)
- [ ] User Requirements Specification (URS)
- [ ] Risk Assessment
- [ ] Validation Plan
- [ ] IQ Protocol and Report
- [ ] OQ Protocol and Report
- [ ] PQ Protocol and Report (if applicable)
- [ ] Traceability Matrix
- [ ] Validation Summary Report
- [ ] Periodic review records
- [ ] Change control history since last validation

### Bundle 2: Data Integrity Evidence
- [ ] Data integrity policy and programme
- [ ] ALCOA+ assessment results
- [ ] Audit trail review records (last 12 months)
- [ ] Data integrity monitoring metrics and trends
- [ ] Data integrity training records

### Bundle 3: Operational Evidence
- [ ] Current SOPs (master list with effective dates)
- [ ] Training matrix (all GxP personnel)
- [ ] Change control log (last 24 months)
- [ ] Deviation/incident log (last 24 months)
- [ ] CAPA log with closure status
- [ ] Internal audit reports and CAPA follow-up

### Bundle 4: System Configuration Evidence
- [ ] User access list (current active users with roles)
- [ ] System configuration documentation
- [ ] Backup and recovery test records
- [ ] Security patch log
- [ ] Business continuity/disaster recovery plan

得：諸包成、索、可於檢者求 30 分內取。 敗：文缺或不全→立缺列、序補、記計。檢者察亂。

四：設假檢則

# Mock Inspection Protocol
## Document ID: MIP-[SITE]-[YYYY]-[NNN]

### Scope
- **Focus areas:** [Top 3-5 risk areas from readiness assessment]
- **Systems in scope:** [Systems likely to be inspected]
- **Duration:** [1-2 days]

### Participants
| Role | Name | Mock Inspection Role |
|------|------|---------------------|
| Mock inspector | [Experienced QA or external consultant] | Ask questions, request documents |
| System owner(s) | [Names] | Respond to questions, demonstrate systems |
| QA | [Name] | Observe, note findings |
| Back room coordinator | [Name] | Locate and provide documents |

### Mock Inspection Scenarios
| Scenario | Focus | Inspector Might Ask |
|----------|-------|-------------------|
| 1: Show me the audit trail | Data integrity | "Show me the audit trail for batch record BR-2025-1234" |
| 2: Walk me through a change | Change control | "Show me the change control for the last system upgrade" |
| 3: Show training records | Training | "Show me the training records for user [Name] on system [X]" |
| 4: Explain your validation | CSV | "Walk me through how you validated this system" |
| 5: Show a deviation | CAPA | "Show me your last critical deviation and its CAPA" |
| 6: User access review | Access control | "Show me how you manage user access when people leave" |

### Post-Mock Assessment
| Scenario | Outcome | Findings | Actions |
|----------|---------|----------|---------|
| [#] | [Satisfactory/Needs Work] | [Description] | [Remediation if needed] |

得：假檢於實檢前顯事。 敗：假檢顯要缺→與實檢見同急。

五：計檢後勤

# Inspection Logistics Plan

### Room Setup
| Room | Purpose | Equipment | Assigned To |
|------|---------|-----------|-------------|
| Front room | Inspector workspace | Table, chairs, network access, printer | Facility manager |
| Back room | Document retrieval and strategy | Copier, network access, phone | QA team |
| Demo room | System demonstrations | Workstation with system access | IT support |

### Roles During Inspection
| Role | Person | Responsibilities |
|------|--------|-----------------|
| Inspection coordinator | [Name] | Single point of contact with inspector, schedule management |
| Subject matter experts | [Names] | Answer technical questions in their domain |
| Back room lead | [Name] | Coordinate document retrieval, track requests |
| Scribe | [Name] | Document all questions, requests, and responses |
| Executive sponsor | [Name] | Available for escalation, opening/closing meetings |

### Communication Protocol
- All document requests flow through the back room lead
- No documents provided without QA review
- Questions requiring research get a "we will get back to you" response (track and follow up)
- Daily debrief with inspection team after each day

得：後勤計確專、組之檢應。 敗：要員不在檢日→識備員告之。

六：立應模

# Inspection Response Templates

### Template 1: 483 Observation Response
[Date]
[FDA District Office Address]

Re: FDA Form 483 Observations — [Inspection Dates] — [Facility Name]

Dear [Inspector Name],

We appreciate the opportunity to address the observations identified during the inspection of [facility] on [dates].

**Observation [N]:** [Quote the exact observation text]

**Response:**
- **Root Cause:** [Brief root cause description]
- **Immediate Corrective Action:** [What was done immediately]
  - Completed: [Date]
- **Long-term Corrective Action:** [Systemic fix]
  - Target completion: [Date]
- **Preventive Action:** [How recurrence will be prevented]
  - Target completion: [Date]
- **Effectiveness Verification:** [How effectiveness will be measured]
  - Target verification date: [Date]

### Template 2: Immediate Correction During Inspection
When an inspector identifies an issue that can be corrected immediately:
1. Acknowledge the observation
2. Implement the correction (if feasible)
3. Document the correction with before/after evidence
4. Inform the inspector that the correction has been made
5. Include in the formal response as "corrected during inspection"

得：應模供速構應檢見。 敗：模通而不對特見→各應含特據與時。

驗

• 機特聚已析含險評
• 備自察畢含量分
• 諸缺補計含主與期
• 諸範系文包成索
• 假檢行含記發與隨
• 檢後勤計定室、職、訊則
• 應模備於常見型
• 諸要補項於檢日前閉

忌

• 末刻備：檢備為續程、非臨陣磨。慌組產亂應
• 隱事：檢者為歷專察隱。明含補計常優於試隱
• 過獻信：答所問。獻未求信開新詢線
• 未訓員：未練應檢者問之專員劣行。假檢為要練
• 忽後室：後室（文取與策協）同重於前室。劣文取生亂象

參

• design-compliance-architecture — 檢者欲見之基檔
• conduct-gxp-audit — 內審當擬檢法
• monitor-data-integrity — 資整為 FDA 檢首聚
• investigate-capa-root-cause — CAPA 必檢前徹查
• qualify-vendor — 商資檢中常求