Laboratory SOP Template (GLP-style)

Lab SOP with GLP-style document control: safety, reagents, steps with critical control points, QC, calculations, training

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Cara menggunakan: Use to write or revise a controlled laboratory procedure. Complete the risk assessment and define critical control points with acceptance limits before the steps. Main pitfall: steps too vague for a trained newcomer to follow, and QC criteria without an action on failure.

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Standard Operating Procedure: [Procedure title]

Laboratory standard operating procedure (SOP) with document control in the style expected under Good Laboratory Practice (GLP) and ISO/IEC 17025-type quality systems: purpose, scope, responsibilities, safety, materials, procedure with critical control points, quality control, calculations, records, troubleshooting, training and revision history. This is a document format, not safety or regulatory advice; your local risk assessment and quality system take precedence. Replace every [bracketed] value and every row marked Example.

Document control

Field	Value
SOP number	[SOP-LAB-0042]
Title	[Procedure title]
Version	[1.0]
Status	[Draft / In review / Approved / Effective / Retired]
Effective date	YYYY-MM-DD
Review due	YYYY-MM-DD [typically 2 years after effective date]
Owner (author)	[@name, role]
Department	[Laboratory or unit]
Supersedes	[SOP-LAB-0042 v0.9 or "none"]
Classification	[Internal]
Copy status	Controlled copy; uncontrolled when printed

Approvals

Role	Name	Signature	Date
Author	[@name]	[Signature]	YYYY-MM-DD
Technical reviewer	[@name]	[Signature]	YYYY-MM-DD
Laboratory manager	[@name]	[Signature]	YYYY-MM-DD
Quality assurance	[@name]	[Signature]	YYYY-MM-DD
Health and safety officer	[@name]	[Signature]	YYYY-MM-DD

Revision history

Version	Date	Author	Change summary	Retraining required
0.9	YYYY-MM-DD	[@name]	Draft for validation runs	Not applicable
1.0	YYYY-MM-DD	[@name]	First approved version	Yes
1.1	YYYY-MM-DD	[@name]	Example: Incubation tolerance changed from +/- 2 min to +/- 5 min after validation data review	No (read and acknowledge)

Purpose
Scope
Definitions and abbreviations
Responsibilities
Safety and hazards
Equipment and materials
Reagent preparation
Procedure
Quality control
Calculations
Data recording and records
Troubleshooting
References
Training record

1. Purpose

This SOP describes how to [perform the procedure] so that results are accurate, reproducible and traceable. Example: This SOP describes how to determine total protein concentration in cell lysates using a bicinchoninic acid (BCA) microplate assay, so that downstream assays load equal amounts of protein.

2. Scope

This SOP applies to all staff performing [the procedure] in [laboratory or unit]. Use outside the validated range below requires a documented justification approved by the laboratory manager.

In scope	Out of scope
Example: Cell lysates in RIPA buffer, 20-2,000 µg/ml	Samples containing more than 5 mM reducing agent
[Instrument model / location]	[Other instruments unless validated]
[Study types, GLP and non-GLP]	[Clinical diagnostic samples]

3. Definitions and abbreviations

Term	Meaning in this SOP
CCP	Critical control point: a step with an acceptance limit that must be checked and recorded
QC	Quality control sample of known value run with each batch
Batch	All samples processed on one plate in one run
LLOQ / ULOQ	Lower and upper limits of quantitation of the validated range
[Term]	[Meaning]

4. Responsibilities

Role	Responsibility
Analyst	Performs the procedure as written, records data contemporaneously, reports deviations
Reviewer	Checks raw data, calculations and QC acceptance before results are released
Laboratory manager	Ensures staff are trained, equipment is maintained and the SOP is current
Quality assurance	Audits compliance, approves the SOP and its revisions
Health and safety officer	Approves the risk assessment and safety controls

5. Safety and hazards

All staff must read the risk assessment [RA-ID] and the safety data sheets before first use. Key hazards and controls:

Hazard	Source	Control	PPE
Example: Skin and eye irritant	BCA working reagent (alkaline)	Handle in tray; avoid splashes	Nitrile gloves, lab coat, safety glasses
[Biological hazard]	[Cell lysates from BSL-2 lines]	[Work in biosafety cabinet]	[Gloves, coat]
[Physical hazard]	[Plate reader moving parts]	[Keep lid closed during run]	Not applicable

Waste disposal:

Waste	Disposal route
Liquid chemical waste	[Labelled alkaline waste container]
Biological waste	[Autoclave or chemical inactivation, then clinical waste]
Plastic consumables	[Biohazard bag if contaminated, otherwise general waste]

Spills and exposure: [Follow spill procedure SOP-HS-0003; eye exposure: rinse at eyewash for 15 minutes and report the incident.]

6. Equipment and materials

6.1 Equipment

Equipment	Asset ID	Requirement
Microplate reader	[ID]	Example: Absorbance at 562 nm, calibration within date
Incubator	[ID]	37 °C +/- 1 °C, verified with calibrated thermometer
Single and multichannel pipettes	[IDs]	Calibrated within 12 months
[Equipment]	[ID]	[Requirement]

6.2 Materials and reagents

Material	Supplier / catalogue no.	Storage	Notes
[BCA reagent A and B]	[Supplier, cat. no.]	Room temperature	Record lot numbers
[Albumin standard, 2 mg/ml]	[Supplier, cat. no.]	4 °C	Do not freeze
[96-well flat-bottom plates]	[Supplier, cat. no.]	Room temperature	Clear polystyrene
[Material]	[Supplier]	[Storage]	[Notes]

7. Reagent preparation

Reagent	Preparation	Stability	Label
Example: BCA working reagent	Mix reagent A and B at 50:1 (for one plate, 10 ml A + 200 µl B). Mix until uniformly green.	24 h at room temperature	Name, date, time, initials
Standard series	Dilute albumin standard in the sample buffer to 2,000, 1,500, 1,000, 750, 500, 250, 125, 25 and 0 µg/ml	Prepare fresh each run	Name, date, initials
[Reagent]	[Preparation]	[Stability]	[Label]

8. Procedure

The procedure is shown as a flow, then as numbered steps.

8.1 Before starting

Confirm the SOP version at the point of use is the current effective version.
Check calibration labels on the plate reader, incubator and pipettes; do not proceed if any is out of date.
Record reagent lot numbers and expiry dates on the run sheet [Form F-0042-1].
Allow reagents and samples to reach room temperature for 30 minutes.

8.2 Procedure steps

Step	Action	Acceptance limit	CCP
1	Prepare the standard series as in section 7	Visible, bubble-free volumes	CCP-1
2	Dilute samples 1:5 in sample buffer if expected above 2,000 µg/ml	Diluted value within the standard range
3	Pipette 25 µl of each standard, QC and sample into duplicate wells following the plate map	Plate map recorded before pipetting
4	Add 200 µl of working reagent to each well with a multichannel pipette	Within 5 minutes across the plate
5	Cover the plate and shake for 30 s
6	Incubate at 37 °C for 30 min	Example: 30 min +/- 2 min, 37 °C +/- 1 °C, start and end times recorded	CCP-2
7	Cool to room temperature for 5 min
8	Read absorbance at 562 nm	Reader self-check passed
9	Export the raw data file to [validated location]	File name per section 11
10	Evaluate standard curve and QC against section 9	All criteria met	CCP-3

8.3 After completion

Dispose of waste as in section 5.
Clean the work area with [disinfectant] and record cleaning on [log].
Submit the run sheet and raw data for review.

9. Quality control

Each batch includes a blank, a full standard curve and QC samples at two levels. The batch is accepted only if all criteria are met.

QC element	Frequency	Acceptance criterion	Action on failure
Blank	Every batch	Example: Absorbance below 0.15	Reject batch; check reagent
Standard curve	Every batch	$R^2 \ge 0.99$ ; back-calculated standards within 15% of nominal	Reject batch; repeat
QC low and high	Every batch, duplicate	Within 20% of assigned value	Reject batch; investigate per deviation SOP
Duplicate agreement	Every sample	CV at most 10%	Repeat the sample

10. Calculations

Fit the blank-corrected standards with a [linear or four-parameter logistic] model. For a linear fit:

A_{\text{corr}} = A_{562} - A_{\text{blank}}, \qquad C = \frac{A_{\text{corr}} - b}{m} \times D

where $m$ is the slope, $b$ the intercept and $D$ the dilution factor.

Precision between duplicates is checked as the coefficient of variation:

\text{CV}\,(\%) = \frac{s}{\bar{x}} \times 100

Example: With $m = 0.00112$ per µg/ml, $b = 0.031$ , $A_{\text{corr}} = 0.871$ and $D = 5$ : $C = (0.871 - 0.031) / 0.00112 \times 5 = 3{,}750$ µg/ml.

Validated calculation template: [Spreadsheet name, version, validation reference].

11. Data recording and records

Record	Format	Location	Retention
Run sheet [F-0042-1]	Paper or ELN	[ELN project / archive]	[Per retention policy, for example 10 years for GLP studies]
Raw data file	[.csv / instrument format]	[Validated server path]	[Period]
Calculation file	[Template]	[Location]	[Period]
Results report	[PDF]	[LIMS]	[Period]

File naming: Example: SOP0042_YYYY-MM-DD_[analyst initials]_[plate number].csv. Corrections are made by a single line through the original, with the correct value, initials, date and reason. Never use correction fluid or overwrite electronic raw data.

12. Troubleshooting

Problem	Likely cause	Action
High blank absorbance	Example: Contaminated or old working reagent	Prepare fresh working reagent; check buffer compatibility
Poor standard curve fit	Pipetting error, wrong dilution	Repeat standards; check pipette calibration
Duplicates disagree	Bubbles in wells, edge effects	Pop bubbles with a clean tip; avoid outer wells
Sample above top standard	Concentration too high	Dilute further and repeat
[Problem]	[Cause]	[Action]

Any failure of a CCP or QC criterion is a deviation and is recorded on [deviation form] with the impact assessment and corrective action.

Deviation handling follows these steps:

Stop and make the situation safe. Do not continue a run that has failed a CCP.
Record what happened, when, and which samples are affected, on the run sheet and the deviation form, the same day.
Inform the reviewer and, for GLP studies, the study director, who decides on the impact on the study.
Investigate the root cause and record corrective and preventive actions with owners and dates.
Quality assurance reviews the deviation log at least [quarterly] and trends recurring causes.

Example: Incubator temperature found at 39 °C at the end of step 6. Batch rejected, samples re-assayed the next day from retained aliquots, incubator taken out of service and recalibrated; root cause was a faulty door seal, replaced under work order [WO-ID].

13. References

Documents referenced by this SOP:

ID	Document
REF-01	[Manufacturer instructions for kit, version]
REF-02	[Method validation report VAL-0042]
REF-03	[Risk assessment RA-ID]
REF-04	[Related SOPs: pipette calibration, deviation handling, waste disposal]
REF-05	OECD Principles of Good Laboratory Practice, as applicable to the study

14. Training record

Trainee	Trainer	Training method	Competence assessed by	Date signed off
[@name]	[@name]	Example: Read SOP, observed 1 run, performed 2 supervised runs with QC passing	[@name]	YYYY-MM-DD
[@name]	[@name]	[Method]	[@name]	YYYY-MM-DD

Standard and licence note

Based on common laboratory quality practice for standard operating procedures, with document control in the style expected under the OECD Principles of Good Laboratory Practice and ISO/IEC 17025-type quality systems. This template is original text written for this collection and reproduces no text from those documents; consult them and your quality system for normative requirements. This is a document format, not safety or regulatory advice. Template licence: MIT.

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