- Document
- QA-01
- Section
- Documentation & quality
- Revised
- Sources checked
Laboratory Documentation for Peptide Handling
What to record from receipt to disposal so that any result can be traced back to the material behind it. Borrowing the useful parts of GLP and data-integrity principles without the bureaucracy.
Bench card
- Record receipt, storage location, every preparation, every use and disposal.
- Follow ALCOA+: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring and available.
- Write it down when you do it, not at the end of the day.
- Correct errors by striking through and initialling, never by erasing or overwriting.
- A unique ID on each container links the label to its record.
Documentation is what lets you, a colleague or a reviewer answer the question “what exactly was in that tube?” months later. For peptides, where degradation is invisible and lots differ, it is the only way to connect a result to the material that produced it.
What to record
| Event | Record |
|---|---|
| Receipt | Date, supplier, compound, lot, quantity, condition, COA status, storage location |
| Storage | Unit, box and position; temperature records for the unit |
| Preparation | Lot, mass, solvent, volume, concentration and basis, date, preparer, solution ID |
| Aliquoting | Number and volume of aliquots, IDs, box positions |
| Use | Aliquot ID, experiment, date, user |
| Excursions and events | Freezer failures, thaws, spills, deviations |
| Disposal | What, when, why, by whom |
ALCOA+ in plain terms
Regulators summarize good records with the acronym ALCOA, extended to ALCOA+. The FDA’s data integrity guidance explains it for regulated manufacturing, but the ideas are just as useful in a research lab.
- Attributable: you can tell who did it.
- Legible: anyone can read it, now and later.
- Contemporaneous: recorded at the time.
- Original: the first record, or a verified copy.
- Accurate: correct, with errors corrected transparently.
- Plus: complete, consistent, enduring and available.
Paper or electronic?
Either works if it is used consistently. Bound notebooks with numbered pages are simple and durable. Electronic notebooks and spreadsheets are searchable, but should keep an audit trail of changes. Regulated settings apply rules such as 21 CFR Part 11 to electronic records and signatures; research labs can borrow the principle of not overwriting data without a trace.
Making corrections
Strike through the error with a single line so it remains readable, write the correct value, and initial and date the change, with a reason if it is not obvious. Never use correction fluid or overwrite.
Monthly audit
CL-06
Monthly storage audit
A short review that catches drift before it becomes a lost sample.
References
- US FDA. Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR Part 58. eCFR
- US FDA. Data Integrity and Compliance With Drug CGMP: Questions and Answers. Guidance for Industry; 2018. FDA
- US FDA. Electronic Records; Electronic Signatures, 21 CFR Part 11. eCFR
- ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories. ISO
- OSHA. Occupational Exposure to Hazardous Chemicals in Laboratories, 29 CFR 1910.1450. eCFR