Annual Product Quality Review (APQR) as per EU GMP: Example SOP
Example SOP for an Annual Product Quality Review (APQR) of oral solid dosage forms under EU GMP Chapter 1 (1.10), with notes on US 21 CFR 211.180(e) and the PQR vs APR difference.
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SOP on Change Control in Pharmaceutical Manufacturing
Example SOP on change control: classification, impact assessment, QA approval, implementation, effectiveness check and regulatory notification, aligned to ICH Q10 and EU GMP.
SOP on Handling of Incidents and Deviations (Example)
Example SOP on handling of incidents and deviations in a pharma plant: raising, classification, investigation, approval, closure, trending and record retention.
SOP for Calibration of Instruments and Measuring Devices (Example)
Example SOP for calibration of instruments and measuring devices: classification, intervals, status labels, traceability, certificates, out-of-calibration.
SOP for Documentation Control Procedure (Example)
Example SOP for documentation control in a pharma plant: master and controlled copies, issuance, retrieval, destruction and record integrity, aligned to EU GMP Chapter 4.
SOP for Reprocessing, Reworking and Recovery of Drug Products
Example SOP for reprocessing, reworking and recovery of drug products: definitions, approvals, batch suffixes, stability and records, for your quality system.
SOP for Management of Reference Standards and Reference Solutions
Example SOP for managing reference standards and reference solutions in a QC laboratory: receipt, storage, validity, working standard qualification, labelling and disposal.
SOP for Risk Management Using FMEA (Example Template)
Example SOP for quality risk management using FMEA: team, severity, probability and detectability scoring, RPN calculation, action plans and records, aligned to ICH Q9(R1).
SOP for Vendor Management in Pharma (Example Template)
Example SOP for pharmaceutical vendor management: risk-based classification, questionnaires, audits, sample evaluation, approved vendor list, agreements, requalification.
SOP for Good Chromatography Practices in QC Laboratory
Example SOP for good chromatography practices in a pharma QC lab: mobile phase, sequence, system suitability, integration, bracketing standards and data review.
SOP on Cleaning Validation (Example Template)
Example SOP on cleaning validation for pharma plants: scope, responsibilities, protocol contents, worst-case selection and health-based (PDE) acceptance limits.