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.
Quality Assurance
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.
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.
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.
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 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.
Validation Master Plan (VMP): Contents and Example Outline
What a validation master plan (VMP) is, what EU GMP Annex 15 expects it to cover, and an example VMP outline with a short explanation of every section.
What Is Data Integrity in the Pharmaceutical Industry?
What is data integrity in pharma? Learn the MHRA and FDA definitions, ALCOA and ALCOA+ principles, data governance and audit trail basics for QA and QC teams.