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SOP: Analytical Testing Protocol Preparation and Control

Last reviewed 27 Oct 2026 · 4 min read

Contents
  1. 1. Objective
  2. 2. Scope
  3. 3. Regulatory background
  4. 4. Responsibility
  5. 5. Procedure
  6. 5.1 Preparation
  7. 5.2 Review and approval
  8. 5.3 Issuance of the master and working copies
  9. 5.4 Execution
  10. 5.5 Review of the completed protocol
  11. 5.6 Revision
  12. 6. Record retention
  13. 7. Training and distribution
  14. 8. Abbreviations
  15. 9. Annexure
  16. Related reading
  17. References

In short: An analytical testing protocol is a controlled worksheet that tells the analyst what to test and records what was done. This example SOP shows how QC prepares it from the specification and test procedure, how QA approves and issues it, and how completed protocols are reviewed. Adapt it to your own quality system.

This is an illustrative template. Titles, approvers and approval levels below are example in-house criteria; adapt them to your own quality system.

1. Objective

To describe how an analytical testing protocol is prepared, approved, issued and controlled in the Quality Control (QC) department.

2. Scope

This example SOP applies to analytical testing protocols used in the QC department of a pharmaceutical manufacturing facility for chemical, instrumental and microbiological testing.

3. Regulatory background

  • Specifications, test procedures and changes to them are drafted by the appropriate unit and approved by the quality control unit; requirements are followed and documented at the time of performance, and any deviation is recorded and justified (21 CFR 211.160(a)).
  • Laboratory records include a statement of each method used, complete raw data, calculations, results, the initials or signature of the analyst and date, and a second-person review of the original records (21 CFR 211.194(a)).
  • Laboratory documentation follows the principles of EU GMP Chapter 4; QC must have ready access to specifications, sampling and testing procedures and records (EU GMP Chapter 6 §6.7). Test records contain at least the data listed in §6.17, including the reference to the specification and procedure, results, dates, the initials of the tester and verifier, and a clear approval or rejection statement.
  • Testing is done according to approved methods (EU GMP Chapter 6 §6.15).

4. Responsibility

RoleResponsibility (example in-house criterion)
QC Officer or designeePrepares the protocol from the approved specification and standard test procedure
QC Head or In-chargeReviews the protocol for technical adequacy; issues it to analysts; reviews the completed protocol
Head QAApproves the final protocol
QAIssues the controlled copy to QC
AnalystPerforms testing, records data contemporaneously and attaches printouts

5. Procedure

5.1 Preparation

  1. The QC Officer or designee prepares the protocol based on the approved specification and the standard testing procedure, with the document numbers and versions referenced.
  2. The protocol is divided into sections as needed: chemical analysis, instrumental analysis and microbiological analysis.
  3. Each test entry contains the test name, reference to the method, acceptance criteria, space for the sample details, instruments and reference standards used, raw data, calculations and results, and analyst and reviewer signatures with dates (see EU GMP §6.17).

5.2 Review and approval

  1. The QC In-charge reviews the protocol for technical adequacy against the specification and test procedure.
  2. The Head QA approves the final protocol.

5.3 Issuance of the master and working copies

  1. QA issues the approved master copy to QC as a controlled copy.
  2. The QC In-charge or designee issues working copies to individual analysts against the samples available for analysis, recording the issue (date, protocol number, sample, analyst). The analyst signs the first page and initials subsequent pages (example in-house criterion).
  3. Unused or spoiled copies are returned and reconciled; they are not discarded unaccounted for.

5.4 Execution

  1. Testing begins only after issue of the protocol and is recorded at the time of performance.
  2. Balance printouts, chromatograms, spectra and other attachments are fixed to the protocol, labelled with the sample and batch, and signed by the analyst.
  3. Any deviation from the test procedure is recorded and justified, and handled under the deviation SOP. An out-of-specification result is handled under the OOS procedure.

5.5 Review of the completed protocol

  1. The QC In-charge, QC Head or authorised designee, who is a different person from the analyst, checks the completed protocol for accuracy, completeness and compliance and signs in the designated place.
  2. Completed protocols are filed with the batch or sample testing records.

5.6 Revision

Any change to the specification or test procedure triggers revision of the protocol through change control; superseded versions are withdrawn from use and retained.

6. Record retention

Completed protocols and attachments form part of the batch quality records. Keep them at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 §4.11, or 5 years after QP certification if longer; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.

7. Training and distribution

Staff are trained in this SOP before using it, as per the employee training SOP. Distribution is as per the SOP on SOPs.

8. Abbreviations

QC: Quality Control. QA: Quality Assurance. SOP: Standard Operating Procedure. OOS: Out of Specification.

9. Annexure

None.

References

  1. US eCFR, 21 CFR 211.160 General requirements (laboratory controls) and 21 CFR 211.194(a) Laboratory records (current text).
  2. European Commission, EudraLex Volume 4, EU GMP Part I Chapter 6: Quality Control (revision in operation from 1 October 2014), §6.7, §6.15, §6.17.
  3. EU GMP Part I Chapter 4: Documentation, §4.11 (retention); 21 CFR 211.180(a).

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