CH 24 · notes
How it works
EU GMP Annex 1 (European Commission, C(2022) 5938 final, 22 August 2022) section 2.5 lists elements to consider in a contamination control strategy. The text says the list is not exhaustive. This page scores those sixteen lines, plus a paraphrase of §2.3 (implement and review the CCS, including management review) and §2.6 (assess changes for impact on the CCS before and after implementation). Quoted lines: 16. Paraphrased lines: 2.
Percent complete is Present divided by Present + Partial + Missing, times 100, half-up to one decimal. N/A and blank rows are excluded. Partial is a gap and does not count as complete. The score is a planning tally. It is not an audit rating.
PIC/S PI 058-1, Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022), was adopted by the PIC/S Committee on 16 October 2026 and entered into force on 28 October 2026. Section 2.1.2 states that its purpose is not to introduce any new GMP requirements. Section 4.2, question 2.3 Q#1, says CCS effectiveness should be reviewed on an ongoing basis, at least during management review, and also for significant change or deviation, a significant emerging problem, and periodic product quality review, with a stated minimum frequency of annual. Question 2.3 Q#2 says there is no set document format: each element should be identified, described, and evaluated. Section 4.1, scope Q#1, says a CCS can also matter for non-sterile manufacture when grade C/D cleanrooms are used to assure product quality, for example a low bioburden product, and that the site should document which Annex 1 principles it applies.
Planning aid only. Not a certified audit, not a site contamination control strategy, and not legal or regulatory advice. Confirm the current EU GMP Annex 1 and PIC/S PI 058-1 text.
Last checked 2026-11-06.
Worked example
Invented title CCS-DEMO-001. Twelve elements are Present, three are Partial (premises and equipment, outsourced activities, and monitoring systems), two are Missing (raw material controls and preventative maintenance), and product containers and closures is N/A. Applicable count is 17. Percent complete is 70.6%. The N/A row is not in that denominator. Load example fills the same invented notes. Clear returns every row to Not assessed.
Related tools
Annex 1 §2.5 (xv) names corrective and preventive actions. Draft that structure on the CAPA & 483 Response page. Endotoxin and pyrogen are named in Annex 1 §2.3–§2.5; the Endotoxin Limit page calculates a USP <85> K/M limit. Cleaning and disinfection is §2.5 (xiii); the MACO / HBEL page calculates a cleaning limit from a PDE.
Sources
- EU GMP Annex 1 (22 Aug 2022) — §2.3, §2.5 (i)–(xvi), and §2.6 CCS elements; the §2.5 list is not exhaustive; in operation 25 Aug 2023 (point 8.123 from 25 Aug 2024)
- PIC/S PI 058-1 (in force 28 Oct 2026) — adopted by the PIC/S Committee 16 Oct 2026; §2.1.2 does not introduce new GMP requirements; §4.1 Q#1 and §4.2 (Annex 1 §2.3 Q#1 and Q#2) on CCS scope, review frequency, and format
FAQ
How is the CCS gap score calculated?
Percent complete is the count of Present divided by Present + Partial + Missing, then multiplied by 100 and rounded half-up to one decimal. N/A and blank rows are left out of that denominator. Partial is a gap. It does not count as complete. The 16 lines under Annex 1 §2.5 are quoted from the 22 August 2022 Commission text. §2.3 and §2.6 are short paraphrases of that same text. The §2.5 list says it is not exhaustive.
Does PIC/S PI 058-1 add new GMP requirements?
No. PI 058-1, section 2.1.2, dated 28 October 2026, states: “Purpose of this document is not to introduce any new GMP requirements.” The PIC/S Committee adopted it on 16 October 2026, and it entered into force on 28 October 2026. This page does not add questions that are not in that text.
How often should CCS effectiveness be reviewed?
Annex 1 §2.3 (22 August 2022) says the CCS should be actively reviewed and that its effectiveness should form part of the periodic management review. PI 058-1 §4.2, question 2.3 Q#1 (28 October 2026), says continued suitability should be assured on an ongoing basis as results are obtained. It recommends review at least during management review, and also during significant change or deviation, a significant emerging problem, and periodic product quality review. The minimum frequency stated there is annual.
Does the CCS have to be one document?
PI 058-1 §4.2, question 2.3 Q#2 (28 October 2026), says there is no set requirement for the format. Each element should be identified, described, and evaluated, with a system for regular review. Where existing control systems are in place and appropriately managed, they may not need replacement, but they should be referenced and the interactions understood. Annex 1 §2.3 uses the same existing-systems sentence.
Can a CCS apply when the site does not make sterile products?
PI 058-1 §4.1, scope Q#1 (28 October 2026), says it can. The example given is a site that does not manufacture sterile medicinal products but uses grade C/D cleanrooms because those classes are deemed necessary for the quality of non-sterile products, such as a low-bioburden product. Annex 1’s scope says that where a manufacturer elects to apply the guidance to non-sterile products, it should document which principles have been applied and acknowledge that compliance with those principles should be demonstrated.
Does this page upload my gap notes?
No. The score and the DOCX or XLSX export stay in the browser. Planning aid only. Not a certified audit, not a site contamination control strategy, and not legal or regulatory advice. Confirm the current EU GMP Annex 1 and PIC/S PI 058-1 text.