Summary of "【Webinar】【医薬品・医療機器】プロセスバリデーションセミナー"

High-level summary

This webinar explains process validation for pharmaceuticals and medical devices, covering regulatory background, core concepts, practical methodology (V‑model: DQ / IQ / OQ / PQ), the lifecycle approach (process design → qualification → continuous verification), computerized system validation (CSV), and differences between pharmaceutical (process) and medical device (discrete) manufacturing needs.

Key lessons

• Validation is future‑oriented: demonstrate the process will consistently produce product meeting predetermined specifications over time (1st, 10th, 1000th lots, years later).
• Verification is past‑oriented: demonstrate a specific product/lot met specifications.
• For equipment, follow the V‑model: capture user requirements, validate design (DQ), verify installation (IQ), verify operation (OQ), and qualify process performance (PQ).
• Use worst‑case / challenge conditions and a risk‑based, statistically justified sample size rather than blindly using “three lots” as a rule.
• Continuous process verification (monitoring) is required after initial qualification/validation—validation is not a one‑time activity.
• Computerized systems must be validated (CSV) in the context of the hardware; automation must not degrade quality or increase risk.
• Some medical device processes are “special processes” (e.g., soldering, welding, bonding, crimping, some sterilization steps) that require validation because downstream inspection is insufficient.
• Retrospective validation (validating already‑installed systems after the fact) is generally no longer acceptable; concurrent validation is allowed only in special, limited circumstances.
• Documentation, change control, requalification, and personnel competence/certification are essential to maintain a validated state.

“Validation ensures ongoing, consistent product quality; verification confirms a past batch met spec.”

Main concepts and background

Regulatory foundations and references mentioned:

• FDA process validation guidance (original 1987 definition; revised guidance 2011 recommending a lifecycle approach).
• ISO 9000 definition (continuous production meeting predetermined specifications).
• ISO 13485:2016 (medical device QMS) and related practical guidance (special processes, sample size/statistics).
• PIC/S Annex 15 (equipment qualification / validation guidance).
• Japanese QMS / MHLW ordinance update (alignment to ISO 13485:2016), with a compliance deadline highlighted (March 26, 2024).

Why validation matters:

• Final product sampling is often insufficient: sampling can miss rare out‑of‑spec items in distribution tails. Process control and validation ensure consistent quality over time and across fluctuating environmental or operational conditions.
• Examples/analogies used in the webinar: bespoke sneakers (DQ/IQ/OQ/PQ), cooking rice and rice cookers (hardware vs software, process parameters), autoclave loading patterns and temperature mapping.

Detailed methodology — V‑model and lifecycle process validation

General lifecycle:

1. Process design
2. Process qualification (DQ → IQ → OQ → PQ)
3. Continued process verification (monitoring / control during routine production)

Before starting: create a Process Validation Procedure that defines scope, roles, timing, plan creation, change control, reporting, approvals, and document storage. Appoint a validation manager.

1) Planning

Produce a Process Validation Implementation Plan including:

• Which process(es) to validate
• Purpose and objectives
• Acceptance criteria (pass/fail)
• Methods and evaluation approach (including statistical rationale)
• Test/sample size rationale and period
• Responsible personnel and approvers
• Implementation organization and resources

2) Design Qualification (DQ)

• Confirm user requirements specification (URS) and regulatory/GMP design requirements are captured.
• Verify design documents/drawings meet the URS before manufacturing or construction of equipment.

3) Installation Qualification (IQ)

On delivery/installation, verify and document equipment is installed per design and manufacturer requirements:

• Installation site, orientation, piping/power/network connections
• Materials of construction and surface finishes (welds, wiring)
• Spare parts lists, manuals, calibration status
• Utility connections (water, air, gas, electricity) and their qualifications where relevant

4) Operational Qualification (OQ)

Demonstrate equipment and systems operate within defined limits and perform intended functions:

• Execute functional tests, empty runs and loaded runs
• Map distributions (e.g., temperature mapping in autoclave) and identify hot/cold spots
• Perform challenge / worst‑case tests within defined operational envelope (bracketing approach can reduce test scope)
• Tests may be supplier‑performed (FAT/SAT can be used as evidence); IQ/OQ may be combined (IOQ) if appropriate and documented

5) Performance Qualification / Process Qualification (PQ / PV)

Demonstrate the process performs consistently under normal operating conditions:

• Run process with normal inputs and parameters; include worst‑case product samples where needed
• Show product meets specifications and process is reproducible—move beyond the blanket “three consecutive lots” rule to a statistical, risk‑based sample size and selection
• Record and analyze deviations; implement corrective actions and change control

6) Validation report & release

• Summarize results, conclusions, deviations, CAPA, and approval decisions
• Ensure all findings are documented and unresolved items are managed via change control and CAPA

7) Continuous Process Verification (Post‑approval monitoring)

Establish ongoing monitoring and controls to ensure the validated state is maintained:

• Routine checks of process parameters (temperature, humidity, set/actual values)
• Alarm thresholds, trend analysis, periodic reviews
• Preventive maintenance and requalification schedule (particularly for aging equipment)
• Revalidation on significant changes, upgrades, or when trends indicate drift

Risk, statistics and the “three lots” rule

• The traditional “validate on at least 3 consecutive lots” rule originated from a need to detect nonlinearity and variability, but it is outdated as a rigid rule.
• Replace prescriptive lot counts with evidence‑based, risk‑based, and statistically justified sample sizes and approaches tailored to the process and its risks.

Differences between pharmaceuticals and medical devices; special processes

• Pharmaceuticals: primarily process industries using fluids; many tests are destructive, so sampling and process validation are relied upon heavily.
• Medical devices: many discrete, inspectable steps allow verification via inspection, gauges, X‑ray, electrical tests. However, “special processes” (soldering, welding, bonding, crimping, sterilization, foreign object inspection) are not easily verified downstream and therefore require validation.
• Human‑dependent inspections: require rigorous training, qualification, certification, and potentially stricter pass criteria. For critical judgments, high competence targets (e.g., near‑100% competence) and frequent re‑training may be required.

Computerized System Validation (CSV)

• Apply CSV per PIC/S Annex 11 and relevant guidance when automating manual tasks (software, firmware, PLCs, microcontrollers).
• Three principles when computerizing:
  1. Do not reduce the number of required controls.
  2. Do not degrade quality.
  3. Do not increase risk.
• CSV must be integrated with hardware qualification — it cannot be performed in isolation from equipment installation/qualification.
• Ensure automation reproduces or improves previous manual performance (use QbD and risk considerations).
• CSV activities should be integrated into DQ / IQ / OQ / PQ where relevant. FAT/SAT and supplier evidence can be leveraged.

Concurrent / retrospective validation and change management

• Retrospective validation (validating an already in‑use process or equipment after the fact) is generally no longer acceptable because of unknown prior changes and risks to future performance.
• Concurrent validation (validating while manufacturing) is permitted only in special, pre‑defined circumstances (e.g., very small batches, emergency/orphan situations) where lot demarcation is impractical.
• Change control: any significant change in equipment, process, utilities, or software requires an impact assessment and appropriate revalidation or verification activities.

Utilities, testing methods and analytical method validation

• Utilities (WFI/purified water, HVAC, compressed air, etc.) require qualification and monitoring.
• Analytical/test method validation is essential — invalid methods undermine process validation conclusions.
• Transportation and distribution are usually handled as verification (e.g., data‑logger evidence), not as a process validation performed in‑facility.

Practical implementation notes and recommendations

• Use supplier FAT/SAT and supplier documentation where possible to avoid duplication; ensure evidence is traceable and acceptable.
• Apply worst‑case and bracketing strategies to reduce the total number of validation runs while covering the most challenging conditions.
• Maintain clear documentation: URS, functional specs, design specs, validation plans, test protocols, records, CAPAs, and validation reports.
• Maintain personnel competence: training, on‑the‑job training (OJT), competency assessment, and stricter pass criteria for critical inspections.
• Plan requalification intervals and define triggers for revalidation (e.g., equipment age, trend deviations, process or equipment changes).

Commercial / practical resources mentioned

• QMSdoog / E‑Compliance: downloadable QMS and validation templates, SOP forms compliant with GMP and ISO 13485:2016; available in editable format and via Rakuten store (advertised during the webinar).
• A beginner’s guide / book on CSV was promoted for those implementing CSV for the first time.

Speakers and sources referenced

• Webinar presenter (unnamed primary narrator)
• QMSdoog / E‑Compliance (templates and services)
• U.S. Food and Drug Administration (FDA) — process validation guidance (1987 original; 2011 revision)
• ISO standards (ISO 9000; ISO 13485:2016)
• PIC/S Annex 15 (equipment qualification and validation guidance)
• Japanese Ministry of Health, Labour and Welfare (MHLW) — QMS ordinance revision
• FDA webinars and API / GMP guidance references
• Practical guidance on ISO 13485 and PIC/S Annex 11 (computerized systems)

Additional notes

• The seminar used multiple analogies (custom shoes, cooking rice, rice cooker) to explain DQ/IQ/OQ/PQ and hardware vs software concepts.
• Advertising/promotional segments for downloadable templates and a CSV book were embedded in the video.
• Subtitles contained transcription errors for some regulatory acronyms and names; the summary interpreted those based on common regulatory context (e.g., “piixGNPanex 15” → PIC/S Annex 15; “FD” → FDA).

Category

Educational

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