Daily Work Plan SOP for a Pharma QC Laboratory

In short: This is an example SOP describing how a QC laboratory plans and runs its day: allocating work, doing routine checks, recording raw data, reviewing results and handing over documents. The daily work plan format and routine checks below are example in-house practices, not regulatory requirements. Adapt them to your own quality system.

Objective

To describe the daily work plan of the Quality Control (QC) laboratory so that testing is allocated, performed, recorded and reviewed in an orderly and traceable way.

Scope

This example SOP applies to routine and non-routine activities of the QC department at a pharmaceutical manufacturing facility.

Regulatory background

There is no regulation that prescribes a “daily work plan” as such. The format is an in-house tool that helps meet general GMP expectations:

• EU GMP Part I, Chapter 6 (Quality Control), paragraph 6.1: the QC department is independent and under the authority of a suitably qualified person, with adequate resources. Paragraph 6.6 says laboratory personnel, premises and equipment should suit the nature and scale of the manufacturing operations.
• WHO good practices for pharmaceutical QC laboratories: the current edition (TRS 1052 Annex 4, 2024, paragraph 6.46) says a sample is stored appropriately until it can be tested according to the laboratory’s workplan. The earlier 2010 edition (TRS 957 Annex 1, section 17.1) added that if testing per the work plan is not feasible, the reason should be noted, for example in the analytical worksheet.
• 21 CFR 211.194(a): laboratory records must include complete data from all tests, with the raw data, the analyst’s initials or signature and date, and a second person’s review.
• EU GMP Chapter 6, paragraph 6.9: data such as test results should be recorded so that trends can be evaluated, and out-of-trend or out-of-specification data should be investigated.

Responsibility

• Analyst: performs the assigned work per approved procedures and records data correctly.
• Section head / department head: allocates work, reviews raw data and results, and decides on investigations.
• Head of QC or designee: receives completed data sheets and keeps the work plan, registers and schedules up to date.

Procedure

Morning: allocation and set-up

1. The section head reviews the previous day’s raw data sheets and work, then allocates the day’s work to each analyst by priority (production needs and urgent requests). Completed and pending items are shown in the daily work plan (Annexure I).
2. The analyst collects the data sheet for each sample to be tested from the section head.
3. Check and record temperature and humidity, where applicable, of the main laboratory and the instrument room at least twice a day (example in-house criterion). Record the reserve sample room conditions in its own record.
4. If a reading is outside the limit given in the relevant form, inform engineering and unit QA immediately so corrective action can start.
5. Carry out the daily checks of the pH meter and the electronic analytical balance every morning (example in-house criterion), following their SOPs.

During the day: testing and recording

1. Do sampling, testing and any other assigned work strictly according to documented procedures, unless the department head authorises otherwise.
2. Record weights, titre values and other observations directly on the raw data sheet when each step is performed, not afterwards from memory or loose paper.
3. Prepare composite and reserve samples as required. Keep reserve samples in the designated place and make the entry in the reserve sample register.
4. Report any difficulty in the test, or any unusual observation on a sample or result, to the section head.
5. Check all raw data and results against specifications and, where applicable, trends. Any result outside specification is handled under the laboratory’s OOS procedure, not by repeating the test on your own.
6. Keep intimation slips (for example GRN or test request slips) in the proper files, not on the workbench except while in use.

After analysis: review and filing

1. Dispose of remaining analytical sample only after the section head has checked the report.
2. After the Certificate of Analysis (COA) is approved, file the completed reports in the respective files.
3. Prepare status labels and affix them to consignments of raw and packing materials as per the site’s labelling procedure.
4. Leave the work area clean, send used glassware for washing and return specifications to their shelves.
5. At day end, hand over the folder of completed test data sheets and related papers to the Head QC or designee.

Section and department head activities

• Discuss promptly any difficulty or any result deviating from specification, and take remedial action.
• Decide, with the department head, whether an OOS investigation is needed and prepare its report. Retesting and resampling are done only as the OOS procedure allows.
• Carry out analysis of samples that are complex or need confirmation of doubtful results.
• Check that the analytical record (AR) register and the schedule or programme are complete and up to date.

Records and retention

Completed data sheets, registers and reports are GMP records. Keep them for at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, paragraph 4.11; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

Training and distribution

• Training: as per the employee training SOP.
• Distribution: as per the SOP on SOPs.

Annexure

• Annexure I: Daily Work Plan (format defined by your site; typically lists date, analyst, sample or test, status as completed or pending, and remarks).

See also

• What are the responsibilities of a quality control department?
• Records maintenance in a quality control laboratory
• SOP for recording temperature, relative humidity and pressure differential
• Out of Specification and Out of Trend investigations (MHRA)

Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• COA: Certificate of Analysis
• GRN: Goods Receipt Note
• OOS: Out of Specification

Frequently asked questions

Is a daily work plan required by GMP?

Not by that name. GMP expects work to be organised, resourced, recorded and reviewed, and a daily work plan is one practical way to show this.

Why enter data directly on the raw data sheet?

Laboratory records must hold complete data from every test (21 CFR 211.194(a)). Writing results at the time of work reduces transcription errors and supports data integrity.

Can an analyst retest a failing sample?

Not on his or her own. Any out-of-specification result goes to the OOS procedure, which decides if and how retesting or resampling is done.

References

1. European Commission, EudraLex Volume 4, Part I, Chapter 6: Quality Control (revision in operation from 1 October 2014), paragraphs 6.1, 6.6, 6.9.
2. European Commission, EudraLex Volume 4, Part I, Chapter 4: Documentation, paragraph 4.11.
3. US FDA, 21 CFR 211.194(a) Laboratory records and 21 CFR 211.180(a) General requirements for records (eCFR, current).
4. WHO, WHO good practices for pharmaceutical quality control laboratories, WHO Technical Report Series No. 1052, 2024, Annex 4 (current edition; paragraph 6.46).
5. WHO, Good practices for pharmaceutical quality control laboratories, WHO Technical Report Series No. 957, 2010, Annex 1 (earlier edition; section 17.1).