What the rules ask for.
Seven standards in plain words, and the service that covers each.
EU GDP
2013/C 343/01 · Distribution of medicinal products in the EU
What it asks for- Mapping before first use, then by risk or after changes (3.2.1)
- Calibration traceable to national standards (3.3)
- Qualified equipment and validated processes (3.3.2)
EU GMP Annex 15
Qualification and validation
What it asks for- Qualification in stages: DQ, IQ, OQ, PQ
- Requalification at a set interval
- Change control before and after modifications
EU GMP Annex 11
Computerised systems
What it asks for- Validated monitoring software
- Audit trail and data integrity
- Backups and access control
WHO TRS 961
Annex 9, Supplement 8 · Temperature mapping of storage areas
What it asks for- 24–72 hours for cold rooms
- At least 7 days for ambient storage
- Seasonal extremes: summer and winter
USP <1079>
United States Pharmacopeia · Storage and transport of drug products
What it asks for- Risk-based storage and distribution controls
- Temperature-controlled storage evidence
21 CFR Part 11
US FDA · Electronic records and signatures
What it asks for- Trustworthy electronic records
- Audit trail and e-signatures
GAMP 5
ISPE · Second edition · Computerised system validation
What it asks for- Risk-based approach to validation
- Scaled to system impact
Plain-language summaries, not legal text. Check the current official version.