지난 OQ 보고서,
지금 기초 자료(Raw Data)를 꺼낼 수 있습니까?

October 1 is a start date, not a starting point.

PIC/S PI 006-4 enters into force on 1 October 2026 — the first revision since PI 006-3 in 2007. Yet almost nothing in it arrives without warning. The stated reason for revision is one line: an update according to the revised Chapters 3 and 5 and Annex 15 of the GMP Guide. Annex 15 was revised in 2015. In i&CP's view, what changes is not the expectation. What changes is that the expectation is now written down in one place.

Statements with clause numbers (#) summarise the text of PI 006-4 and PI 006-3. Interpretation and the "On the floor" items are i&CP's view, not the position of any regulatory authority.

Signal 1 · Not a new obligation list

PI 006-4, Recommendations on Qualification and Validation, describes itself as guidance and a training resource for GMP inspectors and industry (#2.1.2). The Validation Master Plan should be risk-based and scientifically sound (#3.1.1) and include a rationale for the inclusion or exclusion of qualification and validation (#3.4.3 d). If your VMP cannot show why each activity exists, the gap is already visible.

Signal 2 · From PI 006-3 to PI 006-4

The title moved from four listed topics to qualification and validation as a whole. Compared against the text of PI 006-3, the new version adds a quality risk management section, data integrity requirements, URS and FAT/SAT, PQ as a stage of its own, periodic review of the qualified state, ongoing process verification, and transportation, packaging, utilities and test methods. Change control and the reference to raw data were already in PI 006-3. Three statements set the direction: retrospective validation is no longer considered acceptable (#5.2.3); legacy processes should meet current standards through gap analysis and risk assessment (#5.2.3); OPV has taken the place of periodic revalidation (#5.6.3). Run a clause-by-clause comparison, not a summary reading. Document what did not change too — unchanged text you never complied with can still be a finding.

Signal 3 · The data integrity linkage

Data governance should be considered in all aspects of qualification and validation (#2.5.8). The VMP should define requirements to confirm data integrity in qualification and validation reports, completed independently by personnel who did not execute the work (#3.4.3 m). Validation reports should reference the raw data (#5.3.6 f). Qualification generates records, and those records are evidence. i&CP recommends checking three things on every OQ package: whether the audit trail was enabled and reviewed during testing, whether the raw data behind each result is retrievable, and whether static and dynamic records were treated differently. PI 006-4 does not use the term ALCOA; in i&CP's view, ALCOA++ applies to validation records exactly as it applies to production records.

Signal 4 · From document existence to lifecycle evidence

Qualification and validation should follow a lifecycle approach (#2.5.7). Change control maintains the qualified and validated status (#2.6.1); a series of minor changes may represent a major change over time (#4.4.2); process validation is not a one time activity (#5.2.8). Link your data governance and data lifecycle controls to the validated state — otherwise the system is qualified on paper and unqualified in practice.

Overall message

Treat 1 October as a verification deadline, not a preparation deadline. If a requirement in PI 006-4 surprises you, the problem is not the revision — it is that the message since the 2015 revision of Annex 15 never reached your floor.

Validation is not a checkbox. It is evidence that survives inspection.