Concurrent validation in pharma means you confirm process performance while manufacturing and releasing routine batches under a pre-approved protocol. WHO notes that at least 10% medicines in low- and middle-income countries are substandard or falsified, and countries spend about US$30.5 billion yearly on these products.
In this Pharma Validation guide, We’ll cover the rules (WHO GMP validation guidance), the justification package (risk assessment, supply urgency), and how to run it (CQA/CPP plan, sampling, enhanced monitoring, deviation handling, QA/QP disposition, and a final validation report that feeds CPV, with clear acceptance criteria and timelines).
Table of Contents
Concurrent Validation Meaning in Pharma
Concurrent validation checks a process during routine production, while you release batches. You use it when you must supply patients fast. QA leads the plan, and production follows it.
However, therefore, and also, you add extra controls and close monitoring. You document risks, define tests, and confirm results in a report. Then you update the control strategy and continue verification.
- Plan 3 batches with clear acceptance criteria.
- Set sampling points for CQAs and CPPs, then review data.
- Log deviations fast, and start CAPA before the next run.
Concurrent Validation Simple Explanation
Concurrent validation checks your process during real production. You make product and verify the process at once. You use it when urgent supply matters.
However, therefore, you add tighter controls and extra testing. You review results fast and decide batch release.
Use these comparisons to see how concurrent validation differs by timing, evidence, and release risk.
- Concurrent validation vs prospective validation
- Concurrent validation vs retrospective validation
Concurrent vs Prospective vs Retrospective (Purpose, Timing, Risk, Evidence)
| Type | Purpose | Timing | Risk |
|---|---|---|---|
|
Prospective |
Prove before use |
Before routine |
Low |
|
Concurrent |
Prove during use |
During routine |
Med–High |
|
Retrospective |
Prove from history |
After production |
High |
Concurrent Validation vs Prospective Validation
Prospective validation proves the process before routine commercial release. Concurrent validation proves the process during routine production. You choose based on supply urgency and risk. Most firms prefer prospective validation.
However, therefore, concurrent validation needs tighter controls and faster review.
- Prospective: qualify process, then release routinely.
- Concurrent: release with extra testing and oversight.
Concurrent Validation vs Retrospective Validation
Concurrent validation uses real-time data from planned commercial batches. Retrospective validation reviews past batch records and trends. You use concurrent validation when supply matters and you need proof now.
However, therefore, retrospective validation fits stable legacy processes with strong history. Plan concurrent batches with predefined acceptance criteria.
- Concurrent: define sampling, tests, and review steps before manufacturing.
- Retrospective: analyze historical CQAs, CPPs, deviations, and capability trends.
Core Terms Used in Pharma Validation Documents
Validation documents use shared terms to keep teams aligned. For example, the VMP sets the site validation strategy. Then protocols define scope, tests, and acceptance criteria. Reports summarize results, deviations, and conclusions.
However, therefore, you must define technical terms consistently.
CQAs describe critical product quality needs.
CPPs control process conditions that impact CQAs.
IPC describes checks during production.
CAPA fixes root causes and prevents repeats.
CPV tracks ongoing performance after validation.
Protocol Requirements vs Evidence Produced (Document → Output)
| Protocol requirements (Document) | Evidence produced (Output) |
|---|---|
|
Objective + scope |
Approved protocol with version control and signatures |
|
Product + process description |
Process flow map and defined unit operations |
|
Equipment and utilities list |
Qualified equipment list with IQ/OQ references |
|
Roles and responsibilities |
Named owners for execution, QA review, and release |
|
CQA list and targets |
CQA table linked to specs and test methods |
Concurrent Process Validation Protocol IQ OQ PQ Linkage
A good protocol links IQ, OQ, and PQ to one validation story. It shows installed equipment, tested functions, and proven performance. Then it protects product quality.
Therefore, build clear linkages in your protocol.
- IQ confirms installation, utilities, and calibration readiness.
- OQ verifies alarms, ranges, and controls for key functions.
- PQ confirms CQAs during routine runs with defined sampling.
Concurrent Validation Approaches
Concurrent validation runs during routine production under extra controls. You use it when supply urgency prevents waiting. You still follow a written protocol and defined criteria.
You can apply a standard, enhanced, or staged approach. Standard uses normal tests plus added sampling. Enhanced adds tighter ranges, more IPC, and faster QA review. Staged starts with limited release while data grows.
- Standard: stable process, low risk, clear history.
- Enhanced: higher risk, narrow CPP ranges, added monitoring.
- Staged: urgent supply, partial release, then expand with evidence.
Worst Case Approach Concurrent Validation
Worst-case concurrent validation tests your process at limit settings. It proves control. You pick high-risk CPPs and run at limits. You track CQAs.
- Use max batch size and longest hold time.
- Use worst raw material lots and tight ranges.
- Review trends fast and start CAPA.
Bracketing Matrixing Concurrent Validation
Bracketing and matrixing reduce testing while you keep coverage. Bracketing tests the extremes, like smallest and largest batch size. Matrixing tests selected combinations of factors, not every combination. You still protect CQAs and control CPPs.
However, therefore, use bracketing and matrixing only with strong risk logic. Define factors, groups, and sampling upfront. Then justify why skipped runs add low risk. Confirm trends during each concurrent batch and expand testing if results drift.
Final Words
This guide explains concurrent validation in pharma using the ICH lifecycle approach. It splits the work into 3 parts: rules, justification, and execution steps today. ICH Q8(R2) builds product and process understanding, and ICH Q9(R1) drives risk-based decisions. ICH Q10 connects validation to a Pharmaceutical Quality System with 4 elements and 2 enablers.
Final words: use it only with strong justification, tight controls, and fast QA review. Start here checklist: 1) define CQAs/CPPs, 2) write a protocol and criteria, 3) run monitored batches, 4) trend results in CPV, 5) manage post-approval changes using ICH Q12.
FAQs:
Concurrent validation means you collect validation evidence during routine production and you may release batches while you run the protocol, in exceptional cases.
Regulators accept it only in exceptional circumstances, such as limited or infrequent batches or strong patient need. You must justify it, and you must document the decision and controls in your validation system.
You define strict acceptance criteria, add enhanced sampling and monitoring, and run fast QA review for deviations and trends. Then you document the outcome in a validation report and feed learning into ongoing verification.
References
Ershad Moradi, a Content Marketing Specialist at Zamann Pharma Support, brings 6 years of experience in the pharmaceutical industry. Specializing in pharmaceutical and medical technologies, Ershad is currently focused on expanding his knowledge in marketing and improving communication in the field. Outside of work, Ershad enjoys reading and attending industry related networks to stay up-to-date on the latest advancements. With a passion for continuous learning and growth, Ershad is always looking for new opportunities to enhance his skills and contribute to pharmaceutical industry. Connect with Ershad on Facebook for more information.
Dechallenge in Pharmacovigilance: Meaning, ADR Causality, and ICSR Documentation
Dechallenge is what you observe after stopping a suspected medicine. If symptoms improve, you gain supportive evidence for causality assessment. However, improvement alone does not prove the drug caused the event. So, document drug action, dates, and outcomes clearly. Then compare with rechallenge, which can strengthen causality when safe and justified.
Rechallenge in Pharmacovigilance: Meaning, Positive Rechallenge, and ICSR Reporting
Rechallenge in pharmacovigilance helps you assess causality when symptoms recur after re-exposure. This guide explains meaning, where to record outcomes in an ICSR, and how to judge validity. It also shows why clear timelines and dose details protect patients. Strong documentation also builds your Pharmacovigilance Career Path through better case quality.
Concurrent Validation in Pharma 2026 Guide: Meaning, Acceptance, and Execution Steps
Concurrent validation in pharma lets you verify a process while you manufacture saleable batches. Use it only when you face real supply urgency and you can’t wait for prospective validation. Build a risk-based protocol, tighten controls, and document every decision for inspection readiness.