✅ Regulation & quality · 6 min
Records that protect you
A record is your memory in writing. In an inspection, a dispute or a recall, it is also your defence. If it is not recorded, you cannot prove it happened.
Which records matter
- Invoices and delivery notes: what came in, from whom and when.
- Batch records: batch number and expiry for each product received and supplied.
- Temperature logs: refrigerator and room readings, with date, time and the initials of the person who read them.
- Complaint, quarantine, return and disposal records.
- Supplier licences and training records.
How long to keep them
Keep records for the period set by your licence conditions and the current EFDA directives. Do not guess, and never throw records away early because the cupboard is full. Store them dry, filed and easy to find.
How to write a good entry
- Write at the time of the activity, not three days later.
- Write clearly so another person can read it. Use ink.
- Never overwrite, erase or use correction fluid.
- To fix a mistake, draw one line through it so the old entry stays readable, write the correct entry, then add your initials, the date and, if useful, a short reason.
- Never sign for someone else's work. Never pre-sign blank forms.
Electronic records
Computer records count too. Give each user their own password, so every entry shows who made it. Back up regularly and keep one copy in a different place, because one power cut or one stolen computer should not erase your history. Check that you can actually restore the backup.
Sources: WHO Technical Report Series: Good storage and distribution practices for medical products · WHO Technical Report Series: Good distribution practices for pharmaceutical products · EFDA directives (current)
Quick check
For licensed professionals and students. Educational information only: always follow current national guidelines (EFDA, Ministry of Health), the product label and your facility’s procedures.
