Placebo for Analysis: Usage and Upkeep SOP

In short: This example SOP describes how a QC laboratory obtains placebo from Production, stores and labels it, handles it during analysis and disposes of it. It is an illustrative template for QC analysts and QA staff; adapt it to your own quality system before use. All values shown are example in-house criteria.

1. Objective

To describe the procedure for usage and upkeep of placebo used for analysis.

2. Scope

This example SOP applies to placebo used for analysis in the Quality Control department of a manufacturing facility.

3. Responsibility

• Analyst / Section Head (or designee): follow this SOP.
• Head of Quality (or designee): ensure the SOP is implemented.

4. Procedure

4.1 Request and receipt of placebo

1. QC sends a requisition (Annexure I) to Production when placebo is needed for a product made for the first time at the unit, or when a formulation change affects routine analysis.
2. Production prepares the placebo to the requirement.
3. On receipt, place the placebo in a double polythene bag inside an HDPE container. If any component is light sensitive, add an outer black polythene bag.
4. Label the container (Annexure II) with the placebo name and product, date of preparation, valid-upto date and storage condition.
5. Unless otherwise specified, store placebo in a dedicated area at ambient temperature or at the storage condition of the respective product or formulation.
6. Example in-house criterion: validity of placebo is two years from the date of preparation, or less depending on the characteristics of the formulation.
7. Maintain a list of placebos (Annexure III) giving placebo name and product, applicable tests, date prepared and validity.

4.2 Withdrawal and use

1. Use clean, dry accessories to withdraw placebo, and close the container straight after use.
2. For solids, use a clean spatula.
3. For liquid placebo, pour the approximate quantity needed into a beaker or test tube and use that portion. Do not return the remainder to the original container, to avoid contamination.
4. Discard the placebo if foreign particles or contamination are seen.

4.3 Anomalous chromatographic peaks

1. Examine the placebo chromatogram. If unexpected peaks appear, prepare a fresh placebo solution and check again.
2. If the peaks persist, take a fresh portion from the bulk container into a new dispensing container and prepare a fresh solution.
3. If they still persist, inform Production to prepare fresh placebo. Handle the event under your OOS/laboratory investigation procedure where applicable. See HPLC troubleshooting steps.

4.4 Formulation change and disposal

1. When a formulation changes, inform Production, obtain new placebo and use it for that formulation.
2. Dispose of placebo according to the disposal procedure for the respective product.

5. Training

Trainer: Head, Quality Control. Trainees: analysts, officers and section heads.

6. Distribution

Controlled copy 1: Head, Quality Assurance. Controlled copy 2: Head, Quality Control. Master copy: Head, Quality Assurance.

7. Annexures

• Annexure I: Request for placebo for analytical purpose
• Annexure II: Label of placebo
• Annexure III: List of placebo

8. Records

Placebo requests, lists and related analytical records are retained 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. See also checking of analytical reports and data.

References

1. European Commission, EudraLex Volume 4, Part I, Chapter 6 “Quality Control”, §6.19 and §6.21 (laboratory materials prepared and controlled by written procedure; labelling with preparation date, expiry date and storage conditions). These paragraphs name reagents, solutions and reference standards, not placebo; the placebo labelling in this example follows the same idea.
2. US FDA, 21 CFR 211.160(a) (laboratory control procedures are followed and documented at the time of performance, and deviations are recorded and justified).
3. European Commission, EudraLex Volume 4, Part I, Chapter 4, §4.11; 21 CFR 211.180(a) (retention).

10. Revision history