SOP for Sending Samples to an External Laboratory

In short: This is an example SOP for Quality Control teams that send samples to an outside laboratory for tests they cannot perform in-house. It covers laboratory approval, the written agreement, sample packing and labelling, the tracking register and review of the returned report. Adapt it to your own quality system.

Regulatory background

Using an outside laboratory is accepted, but it stays under your control. EU GMP Chapter 6 §6.6 says outside laboratories may be used in line with Chapter 7 for particular reasons, and that this should be stated in the Quality Control records. Chapter 7 (Outsourced Activities) requires:

• a written contract that says who does each step, including sampling and analysis (§7.1, §7.14, §7.15);
• the contract giver to assess the laboratory’s legality, suitability and competence before outsourcing (§7.5);
• the contract giver to review the records and results (§7.8) and to keep the records or have them available (§7.16);
• no subcontracting by the laboratory without the giver’s prior approval (§7.11), and the right to audit (§7.17).

Under US rules, 21 CFR 211.194(a) requires laboratory records to describe the sample received, including its source, quantity, lot number or distinctive code, date taken and date received, and to hold complete test data. Where a contract laboratory is used, the written agreement and approval status of that laboratory should be on file.

1. Objective

To describe how samples are sent to an approved external laboratory for analysis, and how the results are received, recorded and reviewed.

2. Scope

This example SOP applies to the Quality Control department of the manufacturing facility, for tests that cannot be done in the in-house QC laboratory.

3. Responsibility

• Analyst or designee: follows this SOP, packs and labels the sample and updates the register.
• Head of Quality Control or designee: ensures implementation.
• Quality Assurance: verifies the sample entry before dispatch and holds the laboratory approval and agreement.

4. Procedure

1. Send samples only to an external laboratory that is on the approved list. Approval means the laboratory has been assessed (for example by audit or questionnaire) and a written quality or technical agreement is in place, as described above.
2. Check that the required test method and specification have been shared with the laboratory, and that the agreement states whether the laboratory takes the sample or only tests the sample you send.
3. Pack a sufficient quantity, about twice the quantity needed for analysis (example in-house criterion), in a double-lined polybag with a label.
4. The sample label should show: material or product name, batch number, AR number, manufacturing and expiry dates, sample quantity, name of the test, and prepared by (sign and date).
5. Enter the sample in the External Laboratory Analysis Tracking Register (Annexure I) before dispatch.
6. Quality Assurance verifies the register entry when the sample is handed over for dispatch.
7. When the report arrives, record the receipt in the tracking register.
8. The QC analyst reviews the report against the batch number, AR number, test name and specification, and checks that it carries the method used, signatures and date. A second person reviews it as per the QC review procedure.
9. If a result is out of specification, handle it as per the OOS procedure; the external result is not discarded or retested without investigation.
10. File the report with the batch analytical record.

5. Records

Tracking register, laboratory approval and agreement, sample dispatch details and the laboratory report. Keep these 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)), or longer if local law or the marketing authorisation requires.

6. Training

Trainer: Head of Quality Control. Trainees: QC chemists and section heads.

7. Distribution

Controlled copies to Quality Assurance and Quality Control; original copy with Head of Quality Assurance.

8. Annexure

Annexure I: External Laboratory Analysis Tracking Register. Suggested columns: serial number, date, material or product, batch number, AR number, test requested, quantity, laboratory name, dispatched by and QA check (sign and date), report received on, reviewed by, remarks.

9. Revision history

Related reading

• SOP for vendor management
• Records maintenance in the quality control laboratory
• OOS investigation: complete guide
• SOP on sampling of raw materials

Frequently asked questions

Can any laboratory be used for contract testing? No. It must be assessed and approved, and covered by a written agreement before samples are sent.

Who is responsible for the result? The company that sends the sample remains responsible. It must review the records and results.

Can the external laboratory subcontract the test? Only with the sender’s prior evaluation and approval.

References

• European Commission, EudraLex Volume 4, EU GMP Part I Chapter 7 Outsourced Activities (Revision 1, in operation 31 January 2013), §7.1, 7.5, 7.8, 7.11, 7.14-7.17.
• European Commission, EudraLex Volume 4, EU GMP Part I Chapter 6 Quality Control (revision in operation 1 October 2014), §6.6.
• European Commission, EudraLex Volume 4, EU GMP Part I Chapter 4 Documentation (2011), §4.11.
• US FDA, 21 CFR Part 211, §211.194(a) Laboratory records, and §211.180(a) (eCFR, current).