Every activity in Pharma have some frequencies whether it is revision of documents, qualification, validation, stability, Re-testing etc. While Acceptance criteria means numerical limits, ranges, or other criteria for tests that are used for or in making a decision to accept or reject a unit, lot, or batch of a PET drug product.
- Warehouse Frequencies
- Acceptance Criteria used in Warehouse
- Tablets (Principle/Frequencies/Acceptance Criteria/References)
1. Principles in Pharma (GMP / Quality Principles)
Key principles that govern all testing, monitoring and decisions:
- Patient safety first – no compromise on product quality and purity.
- GMP compliance – WHO GMP, Schedule M, EU-GMP, US FDA cGMP etc.
- Risk-based approach – apply ICH Q9; more risk ⇒ more controls & checks.
- Lifecycle / science-based decisions – align with ICH Q8–Q11 (development → validation → commercial).
- ALCOA+ data integrity – Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available.
- Continuous improvement – use deviations, OOS/OOT, complaints, audits and trends to improve processes.
2. Frequencies (How Often Things Are Done)
Typical examples (you can customise for your site/SOPs):
- Environmental monitoring (EM)
- Grade A/B: every batch / shift or continuous (viable & non-viable).
- Grade C/D: daily to weekly based on risk.
- Cleaning validation / verification
- Initial 3 consecutive successful runs for validation.
- Then routine cleaning verification every batch or at defined intervals until sufficient trend data.
- Equipment qualification / calibration
- Critical balances, thermometers, pressure gauges: usually 6–12 months.
- HPLC/GC qualification: at defined intervals or performance-based.
- Product testing
- In-process controls (IPCs): as per stage (e.g. every 30 mins for compression).
- Routine finished product testing: every batch.
- Stability studies: as per ICH (0, 3, 6, 9, 12, 18, 24 months etc. for long-term/accelerated).
Make sure you mention that frequencies are justified via risk assessment & historical performance, not arbitrarily chosen.
3. Acceptance Criteria (Pass / Fail Limits)
These are the predefined limits that determine whether a result is acceptable:
- Pharmacopoeial limits
- Assay, related substances, dissolution, uniformity etc. as per IP/BP/Ph.Eur/USP monographs.
- Environmental limits
- Viable & non-viable particles in cleanrooms as per ISO 14644 / EU GMP Annex 1.
- Microbial limits
- Total viable count, absence of pathogens, sterility criteria as per pharmacopeia.
- Process-specific limits
- Blend uniformity %RSD, granule LOD, tablet hardness/friability etc. set during development/validation.
- Cleaning limits
- MACO (Maximum Allowable Carry Over) based on toxicological/therapeutic data and batch size.
4. References (Regulatory & Internal)
You can list typical reference sources used to define principles, frequencies and criteria:
External (Regulatory / Standards)
- Schedule M / national GMP rules
- WHO GMP, EU-GMP, US FDA 21 CFR Parts 210/211
- ICH Guidelines
- Q7 (API GMP)
- Q8 (Pharmaceutical Development)
- Q9 (Quality Risk Management)
- Q10 (Pharmaceutical Quality System)
- Q11 (Development & Manufacture of Drug Substances)
- Pharmacopoeias – IP, BP, USP, Ph. Eur.
- ISO 14644 for cleanrooms and associated controlled environments.
Internal
- Site SOPs and validation protocols/reports
- Risk assessment reports (FMEA, HACCP, 6M-based etc.)
- Change control and deviation reports
- Annual Product Quality Review (APQR/PQR)
| Area | Example Frequency | Acceptance Criteria (Example) | Key References |
|---|---|---|---|
| Environmental Monitoring (Grade A) | Every batch / shift or continuous | Zero CFU; particle limits as per Annex 1 | EU-GMP Annex 1, ISO 14644, SOP… |
| Finished Product Assay | Every batch | 95.0–105.0% of label claim | IP/USP monograph, SOP… |
| Cleaning Verification | Every batch (initial); then risk-based | Residual API ≤ MACO; visually clean | Cleaning validation protocol… |
| Balance Calibration | Every 6–12 months | Within predefined tolerance | Metrology SOP, manufacturer… |