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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Clear, reviewed explanations of GMP, validation, QC testing, microbiology and SOPs — written for people who do this work every day.
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- SOP (11)
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- Validation (5)
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Latest articles
CAPA Process: 15 Step-by-Step Instructions for Pharma QA
Follow a 15-step CAPA process from request and root cause to action plan and effectiveness check, with notes on ICH Q10 and GMP expectations for pharma QA teams.
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.
Cleaning Validation Protocol Format and Acceptance Criteria
Cleaning validation protocol format for pharma: sections to include, example acceptance criteria for analytical methods, swab recovery, and common myths.
Data Integrity Problems in an FDA Warning Letter: Lessons
Data integrity findings in a 2022 FDA warning letter: shared admin logins, no audit trail review and weak remediation, explained against 21 CFR 211 and FDA's Q&A.
Why FDA's OOS Expectations Exist: The Barr Laboratories Case
Why FDA expects strict OOS handling: the 1993 Barr Laboratories ruling on retesting, averaging and outlier tests, and how it shaped FDA's OOS guidance.
High Purity Water Systems: FDA Inspection Guide Explained
What the FDA high purity water inspection guide covers, and what current USP, Ph. Eur., EMA and WHO texts expect from Purified Water and WFI systems today.
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.
OOS Investigation (US FDA): Phase I Laboratory Investigation
Phase I laboratory investigation of an out of specification (OOS) result under US FDA guidance: analyst and supervisor duties, checks and documentation.
OOS Investigation (US FDA): Phase II Full-Scale Investigation
Phase II of an OOS investigation under US FDA guidance: production review, retesting, resampling, averaging, outlier tests and batch disposition decisions.
HPLC Calibration Guide Part 1: Parameters and Procedures
HPLC calibration explained: example calibration parameters and frequencies, with pressure test, drift and noise, oven, flow and gradient checks for QC labs.
OOS Investigation Phase Ia and Ib: MHRA Laboratory Stages
Out of specification investigation Phase Ia and Phase Ib explained as per MHRA guidance: obvious errors, laboratory checklist, hypothesis testing and when to go to Phase II.
OOS Investigation Phase II (MHRA): Retesting and Averaging
Understand the MHRA Phase II out-of-specification investigation: hypothesis testing, retesting, resampling, averaging rules and outlier tests, explained for QC and QA staff.
Out-of-Trend (OOT) Results: Meaning, Detection and MHRA Expectations
What an out-of-trend (OOT) result is, how it differs from OOS, how stability data are trended, and what MHRA's OOS and OOT investigation guidance expects.
ICH Q10 PQS Elements and Change Management System
Understand the four ICH Q10 pharmaceutical quality system elements: process monitoring, CAPA, change management and management review, and how they apply across the lifecycle.
Principles of Cleaning Validation in Pharma (Annex 15)
Principles of cleaning validation explained: lifecycle approach, worst-case selection, health-based limits (HBEL), visual clean, hold times and verification.
Quality Risk Management in Pharma (ICH Q9 R1) Explained
Learn quality risk management in the pharmaceutical industry under ICH Q9(R1): process steps, risk assessment, control, review, common tools, and what changed in 2023.
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.