List of SOPs for Pharmaceutical Quality Assurance
Contents
In short: This is a checklist of the Standard Operating Procedures a pharmaceutical Quality Assurance department commonly maintains. Where we have published an example SOP, the title is linked. It is a starting point, not a mandatory list: your own products, markets and regulators decide what you need.
How to use this list
GMP requires written procedures for activities that affect product quality (see EU GMP Part I Chapter 4 on documentation and 21 CFR Part 211 for finished pharmaceuticals). The exact set of SOPs is a site decision based on its quality system, risk assessment and regulatory commitments. Use this list to check for gaps, then write each SOP in your own words and have it approved under your document control system. Our linked pages are example SOPs, to be adapted before use.
Quality Assurance SOPs
| SOP topic |
|---|
| SOP of SOP |
| SOP for change control |
| SOP for handling of incidents and deviations |
| SOP for training of employees |
| SOP for self-inspection |
| SOP for risk management |
| SOP for documentation control |
| SOP for corrective and preventive action (CAPA) |
| SOP for process validation |
| SOP for cleaning validation |
| SOP for evaluation and approval of contract testing laboratory |
| SOP for failure investigation |
| SOP for market complaint |
| SOP for handling of reprocessing, reworking and recovery |
| SOP for qualification stages of equipment, systems and utilities |
| SOP for out of specification (OOS) |
| SOP for product recall |
| SOP for new product introduction |
| SOP for process performance and product quality monitoring and management review |
| SOP for line clearance |
| SOP for handling of rejected materials |
| SOP for handling of artwork |
| SOP for Annual Product Quality Review |
| SOP for vendor qualification |
| SOP for review of batch manufacturing record |
| SOP for document storage |
| SOP for calibration |
| SOP for mock recall |
| SOP for water system qualification and validation |
| SOP for preparation, review and approval of batch records (BMR/BPR) |
| SOP for sampling of semi-finished and finished products |
| SOP for in-process checks |
| SOP for sampling of rinse and swab samples |
| SOP for item code generation of raw and packing material |
| SOP for product code generation |
| SOP for batch numbering system |
| SOP for assigning manufacturing and expiry dates for finished product |
| SOP for operation, cleaning and calibration of weighing balance |
| SOP for preparation and review of site master file |
| SOP for out of trend (OOT) |
| SOP for technology transfer |
| SOP for operation and cleaning of sampling rod |
| SOP for trend analysis |
| SOP for men and material movement |
| SOP for power failure |
| SOP for creation, control, revision, access and archival of electronic documents |
| SOP for post-marketing surveillance of marketed products |
| SOP for handling of data loggers during distribution and transportation of finished goods |
| SOP for dispatch of finished goods for the EU market |
| SOP for acceptance quality limit (AQL) |
| SOP for operation of data loggers, monitoring of temperature and relative humidity, and evaluation of recorded data |
| SOP for handling of product yield |
| SOP for validation and verification of analytical methods |
| SOP for reconciliation of packing material |
| SOP for allocation of pharma code |
| SOP for glass breakage policy |
| SOP for document numbering system |
| SOP for recording of temperature, relative humidity and pressure differential |
| SOP for data integrity |
| Validation master plan |
| SOP for batch release of finished product |
Related reading
Frequently asked questions
Is every SOP in this list mandatory?
No. GMP expects documented procedures for activities that affect quality, but which SOPs you need depends on your operations, products and the regulations you work under. For example, an EU-market dispatch SOP applies only if you supply that market.
How should SOPs be kept up to date?
Review each SOP at a defined interval (an example in-house criterion is every 2 to 3 years) and whenever a change, deviation or inspection finding affects the procedure, using your document control system.
How long should SOPs and related records be retained?
Superseded SOPs and the records created under them are kept at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 §4.11; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.
References
- EudraLex Volume 4, EU GMP Part I, Chapter 1 (Pharmaceutical Quality System) and Chapter 4 (Documentation), European Commission.
- 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, US FDA.
- ICH Q10 Pharmaceutical Quality System, 2008.
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