Chromatographic Analysis Naming SOP

In short: This example SOP organizes method, program, sequence and maintenance labels used in HPLC and GC analysis. Its codes are local naming conventions, not regulatory formats. Confirm them in the site’s controlled list and validated chromatographic data-system procedure, and preserve complete, attributable records when runs are repeated or continued.

Objective

Describe a consistent, traceable way to identify chromatographic program files, quantification methods, analysis sequences and maintenance runs.

Scope

This template is for HPLC and GC work managed through the site’s approved chromatographic data system. Adapt the examples to the installed software and controlled methods. The naming patterns below do not replace product, batch, sample, method or instrument identifiers required by the applicable record system.

For FDA-regulated operations, 21 CFR 211.194(a) requires complete laboratory data and identifies the tested material and lot; 21 CFR 211.68(b) requires controls over changes to records in computer-related systems and checks of input and output accuracy. EudraLex Volume 4, Annex 11, Computerised Systems, Revision 1 (2011), describes risk-based audit-trail controls in §9 and access controls in §12.1. These sources address records and system controls; they do not prescribe the filename patterns shown in this example.

Responsibility

• Analyst or designee: Use the approved naming convention, select the correct product, batch, sample, method and instrument identifiers, and record analysis activity under the site’s approved procedure.
• QC system or process owner: Maintain the controlled convention and assess changes to the naming or sequence workflow.
• Quality unit: Review and approve the controlled procedure and ensure that required records remain traceable and retrievable.

Example in-house criterion (not a pharmacopoeial requirement): This example SOP uses local role titles and assigns document ownership, training and distribution responsibilities. Confirm them before adopting this template.

Procedure

General naming controls

1. Use only the current approved convention and controlled product and test abbreviations.
2. Ensure that a file or sequence label can be associated with the actual product, batch, sample or preparation, method and instrument through the chromatographic data system and its records.
3. Use the system’s approved date format and confirm that identifiers remain unique across dates, instruments and repeat runs.
4. Do not rename or reuse identifiers in a way that obscures original data, results or audit trails. For computerized systems within scope of EU GMP Annex 11, §9 describes risk-based audit-trail controls for GMP-relevant changes and deletions; FDA’s 2018 data-integrity guidance discusses reliable, accurate CGMP records and system controls. Follow the applicable jurisdiction and the site’s validated data-system procedure.
5. If a run is repeated, continued or reprocessed, use the approved system workflow and retain the original result and the relationship between the original and subsequent activity.

Example naming patterns

Example in-house criterion (not a pharmacopoeial requirement): The following table gives example local tokens and patterns. Treat them as site conventions to be approved and configured, not as universal names.

This example uses two-digit day numbers in some date examples without showing a month and year in the sequence label. Choose only a date convention approved for the data system, and ensure the complete analytical record remains unambiguous. The product and test abbreviations must come from a controlled site list rather than being improvised for an individual run.

Repeated or continued sequences

Example in-house criterion (not a pharmacopoeial requirement): This example SOP uses new suffixes such as P1/P2/P3 for additional program files, Q1/Q2/Q3 for additional method files, B1/B2/B3 for repeated sample sequences and Ca1/Ca2/Ca3 for repeated calibration sequences. It also appends repeat injections and next-day continuations to existing pre-evaluation sequences, appends repeats to an existing maintenance flushing sequence, and uses C/D/E/F for multiple sequences sharing a pre-evaluation and system-suitability sequence. Confirm each behavior in the current validated data-system procedure before use.

Example in-house criterion (not a pharmacopoeial requirement): This example SOP also changes the product abbreviation in the pre-evaluation, system-suitability and sample sequences when the same product is tested on the same day and system using entirely new preparations. Do not apply that instruction without confirming that the resulting labels still map unambiguously to the actual product, batch and preparations.

Data and record review

For FDA-regulated operations, 21 CFR 211.194(a) specifies that laboratory records include complete test data, sample source and lot or other distinctive code, the method used, data generated, results, the person performing the test and the date. Use the applicable requirements for the product and jurisdiction.

For a GMP computerized system within scope of EU GMP Annex 11, Revision 1 (2011), §9 describes risk-based audit trails for GMP-relevant changes and deletions, including documenting reasons for changes or deletions; §12.1–12.4 describe restricting and recording access authorisations and identifying operators who enter, change, confirm or delete data. FDA’s Data Integrity and Compliance With Drug CGMP: Questions and Answers, Guidance for Industry (December 2018), is nonbinding and discusses reliable, accurate records and risk-based controls.

Before approving a result, follow the site’s procedure for checking the run record against the approved method and sample identifiers. Preserve initial, repeated and processed data according to the validated system and approved recordkeeping procedure. Do not use a naming convention as a substitute for the underlying metadata or audit trail.

Training

Train analysts and other assigned personnel on the controlled naming list, data-system workflow, method selection and records required for their tasks. Document training in the site’s training system.

Example in-house criterion (not a pharmacopoeial requirement): This example lists the Head of QC as trainer and sectional heads, analysts and officers as trainees. Confirm the current training owner and audience.

Records and retention

Retain the approved abbreviation list, method and program version history, sequence records, raw chromatographic data, audit trails, calculations, result review, repeat-run rationale and training records according to the applicable procedure. Keep batch-associated GMP records for at least 1 year after the expiry date of the respective product batch. Where EU GMP applies, Chapter 4, §4.11 requires batch documentation to be retained at least 5 years after QP certification if that is longer. Follow longer periods required by local law, the marketing authorisation or the approved site schedule. See EudraLex Volume 4, Part I, Chapter 4, Revision 1 (effective 30 June 2011), §4.11 and 21 CFR 211.180(a), current eCFR.

Distribution

Distribute the controlled procedure and its current naming list to the roles that need them. Example in-house criterion (not a pharmacopoeial requirement): This example lists controlled copies for the Heads of QA and QC and an original for QA; verify the current controlled-copy process before using that list.

Abbreviations

• API: Active pharmaceutical ingredient
• CDS: Chromatographic data system
• GC: Gas chromatography
• HPLC: High-performance liquid chromatography
• QC: Quality control
• QA: Quality assurance

Frequently asked questions

Does this naming scheme satisfy data-integrity requirements by itself?

No. A label helps users find a record, but the data system and approved procedures must retain the required analytical data and traceability. Use applicable regulatory requirements and validated system controls.

Should a repeat injection be added to an existing sequence?

Use the installed data system’s approved repeat-run procedure. This example SOP appends to or reuses some sequences; confirm that this workflow preserves the original data, metadata and audit trail.

Is the two-digit date token enough to identify a run?

The examples show only a day number. Confirm the approved date and identifier format with the data-system owner so a label cannot be confused across months, years or instruments.

See also: Good chromatography practices SOP, HPLC working in a Chromeleon network, HPLC calibration guide, Part 1, and FDA warning letter on unofficial HPLC injections and shared logins.

References

• United States, 21 CFR 211.68(a)–(b), “Automatic, mechanical, and electronic equipment,” eCFR version up to date as of 14 October 2026: official regulation.
• United States, 21 CFR 211.194(a), “Laboratory records,” eCFR version up to date as of 14 October 2026: official regulation.
• United States, 21 CFR 211.180(a), “General requirements,” eCFR version up to date as of 14 October 2026: official regulation.
• U.S. Food and Drug Administration, Data Integrity and Compliance With Drug CGMP: Questions and Answers, Guidance for Industry (December 2018), nonbinding: official guidance page and official PDF.
• European Commission, EudraLex Volume 4, Annex 11, “Computerised Systems,” Revision 1 (effective 30 June 2011), §§9 and 12: official PDF.
• European Commission, EudraLex Volume 4, Part I, Chapter 4, “Documentation,” Revision 1 (effective 30 June 2011), §4.11: official PDF.

Revision history