Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production, which establishes scientific evidence that a process is capable of reliably providing quality output.”

The lifecycle idea is a cornerstone of this FDA guidance statement. The lifecycle approach takes into account not only the earliest stages of medication research but also the creation of commercial manufacturing and ongoing commercial production up until the product is discontinued.

The need for quality assurance measures to be incorporated into each stage of the medication manufacturing process is another fundamental idea behind validation.

The 3 stages of process validation are:

• Process Design – The commercial manufacturing process is defined.
• Process Qualification – The design is evaluated to determine whether the processes meet demands of reproducibility.
• Continued Process Verification – Ongoing assurances that all processes remain in a state of control.

1. PV Protocol (Uncoated Tablets)
2. PV Report (Uncoated Tablets)
3. PV Protocol (Coated Tablets)
4. PV Report (Coated Tablets)
5. Process Validation Protocol of Pyridoxine Sustained Release Tablets
6. Process Validation Report of Pyridoxine Sustained Release Tablets
7. Packing Process Validation Protocol for Strip (Ferrous Ascorbate, Folic Acid and Cyanocobalamin Tablets)
8. Process Validation Protocol for Acyclovir (Sterile)
9. Process Validation Report for Acyclovir (Sterile)
10. Process Validation Protocol for Pantoprazole Sodium (Sterile)
11. Process Validation Report for Pantoprazole Sodium (Sterile)
12. Process Validation Protocol for Calcitriol & Multivitamin Softgel Capsules
13. Process Validation Report for Calcitriol & Multivitamin Softgel Capsules
14. Process Validation Protocol for Ciprofloxacin Ophthalmic Solution BP 0.3% (5 ml)
15. Process Validation Report for for Ciprofloxacin Ophthalmic Solution BP 0.3% (5 ml)
16. Process Validation Protocol for Lidocaine Injection BP 2% w/v, 20 ml
17. Process Validation Report for Lidocaine Injection BP 2% w/v, 20 ml
18. Process Validation Protocol for Tranexamic Acid Injection BP 100 mg per ml (500 mg in 5 ml) Ampoule Section
19. Process Validation Report for Tranexamic Acid Injection BP 100 mg per ml (500 mg in 5 ml) Ampoule Section
20. Process Validation Protocol for Sugar Sphere
21. Process Validation Report for Sugar Sphere
22. Process Validation Protocol for Levocetirizine Dihydrochloride Syrup
23. Process Validation Report for Levocetirizine Dihydrochloride Syrup
24. Process Validation Protocol for Prebiotic and Probiotic Hardgel Capsules
25. Process Validation Report for Prebiotic and Probiotic Hardgel Capsules
26. Process Validation Protocol for Dutasteride Pellets (0.5%)
27. Process Validation Report for Dutasteride Pellets (0.5%)
28. Bin Blender Validation Protocol
29. Bin Blender Validation Report
30. Compression Validation Protocol
31. Compression Validation Report
32. Coating Validation Protocol
33. Coating Validation Report
34. Blister Packing Validation Protocol
35. Blister Packing Validation Report
36. Hopper Depletion Study Protocol
37. Hopper Depletion Study Report

Process Validation in Pharma – Complete, Practical Guide

Process Validation is a GMP requirement that proves, with documented evidence, that a manufacturing process consistently produces a product meeting its pre-defined quality attributes.

US FDA defines process validation as the collection and evaluation of data from process design through commercial production to show that a process can consistently deliver quality products. U.S. Food and Drug Administration+1

Modern process validation follows a lifecycle approach aligned with:

• FDA Process Validation Guidance (2011, updated material 2023) U.S. Food and Drug Administration+1
• ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) European Medicines Agency (EMA)+2Ideagen+2
• EU GMP Annex 15 – Qualification and Validation and EMA Process Validation guideline European Medicines Agency (EMA)+3Public Health+3European Medicines Agency (EMA)+3

1. What Is Process Validation?

Definition (simplified):
Process Validation is a documented, science- and risk-based approach to show that a manufacturing process, operated within established parameters, consistently produces product of the required quality.

Key Goals

• Assure patient safety and product efficacy
• Demonstrate process consistency and capability
• Support regulatory submissions and inspections
• Maintain a state of control throughout the product lifecycle

2. Lifecycle Approach – Three Stages of Process Validation

Regulatory guidance (FDA, EMA, ICH) now treats process validation as a lifecycle, not a one-time exercise. gmp-navigator.com+4U.S. Food and Drug Administration+4U.S. Food and Drug Administration+4

Stage 1 – Process Design

The commercial manufacturing process is defined and developed based on:

• Quality Target Product Profile (QTPP)
• Critical Quality Attributes (CQAs)
• Material attributes and Critical Process Parameters (CPPs)
• Scale-up and DoE studies
• Risk assessments (ICH Q9 tools)

Output: A defined process and control strategy that should be capable of delivering the desired product quality.

Stage 2 – Process Qualification

In Stage 2, the designed process is proven on the actual equipment and facility intended for commercial manufacturing.

It has two main elements:

1. Qualification of Facilities, Utilities & Equipment
   • IQ/OQ/PQ of equipment and systems
   • Calibration and maintenance in place
2. Process Performance Qualification (PPQ)
   • Manufacture of consecutive validation/PPQ batches at commercial scale
   • Demonstration that the process performs as expected and is reproducible
   • Collection of in-process and release data against predefined acceptance criteria

Output: Evidence that the process, under routine conditions, is capable of producing compliant product.

Stage 3 – Continued Process Verification (CPV)

After successful PPQ, Stage 3 ensures ongoing assurance that the process remains in a state of control during routine production. U.S. Food and Drug Administration+1

Typical CPV activities:

• Continuous / periodic review of critical process data and trends
• Monitoring CPPs, CQAs, yields, deviations, OOS/OOT
• Using statistical tools (control charts, capability indices)
• Feeding back into PQS, CAPA, change management and continual improvement (ICH Q10) IntuitionLabs+1

3. Types of Process Validation

Traditionally, process validation is classified as:

1. Prospective Validation
   • Performed before commercial distribution
   • Planned PPQ batches using an approved protocol
   • Current regulatory preferred approach
2. Concurrent Validation
   • Validation performed during routine production, with real market batches
   • Used only in justified cases (e.g. orphan drugs, very small markets) and under strict control. European Medicines Agency (EMA)
3. Retrospective Validation
   • Based on historical data from existing, stable processes
   • Largely discouraged under modern lifecycle expectations; mainly for older, well-established processes with extensive data.
4. Continued / Continuous Process Verification (CPV)
   • A modern, lifecycle-based approach where validation is maintained through ongoing data collection and analysis throughout commercial life. ICH Database+1

4. Key Elements of a Process Validation Program

4.1 Process Validation Master Plan (PVMP)

A high-level document that defines:

• Scope (products, sites, dosage forms)
• Overall strategy (traditional PV vs CPV, risk-based approach)
• Responsibilities (QA, QC, Manufacturing, Validation, Engineering)
• List of systems and processes requiring validation
• Schedule and timelines

4.2 Risk Management (ICH Q9)

Quality Risk Management tools are used to:

• Identify critical steps and parameters
• Prioritize studies and controls
• Support decisions on sample size, number of batches, and monitoring strategy European Medicines Agency (EMA)+1

4.3 Design of Experiments & Development Studies (Stage 1)

• DoE, scale-up, and robustness studies
• Establish linkage between input variables (materials, CPPs) and outputs (CQAs)
• Definition of design space (if using enhanced/QbD approach)

4.4 Control Strategy

A comprehensive control strategy typically includes:

• Raw material specifications
• In-process controls and CPP ranges
• Equipment controls (alarms, interlocks)
• Finished product specifications
• Real-time and trending tools (PAT where applicable)

5. Practical Step-by-Step Flow

1. Step 1 – Define Product & Process (Stage 1)
   • QTPP, CQAs, process flow diagram, risk assessment.
2. Step 2 – Develop & Optimize Process
   • Lab / pilot experiments, DoE, scale-up, identification of CPPs.
3. Step 3 – Prepare Process Validation Strategy & PVMP
   • Decide on number of batches, sampling, acceptance criteria.
4. Step 4 – Qualify Equipment & Systems (Q&V)
   • IQ/OQ/PQ of equipment, utilities, facilities.
5. Step 5 – Execute PPQ Batches (Stage 2)
   • Run PPQ batches as per approved protocol.
   • Collect extensive data (in-process & finished product).
6. Step 6 – Evaluate Results & Approve Report
   • Statistical analysis, deviations investigation, conclusion.
   • QA approval of PPQ report.
7. Step 7 – Implement Continued Process Verification (Stage 3)
   • Routine monitoring program, defined KPIs and trend analysis.
   • Regular review with QA, Validation and Manufacturing.

6. Regulatory Framework – Snapshot

Your website can highlight that your process validation approach complies with:

• US FDA – “Process Validation: General Principles and Practices” (2011, lifecycle approach; subsequent materials 2023) U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2
• ICH Q8, Q9, Q10 – science- and risk-based development, QRM, PQS across lifecycle European Medicines Agency (EMA)+2Ideagen+2
• EU GMP Annex 15 – Qualification and Validation and EMA Process Validation Guideline for Finished Products (chemical and some biologics) European Medicines Agency (EMA)+3Public Health+3European Medicines Agency (EMA)+3

You can also mention that your approach follows recent interpretations and best practices summarizing the modern lifecycle + CPV expectations. gmp-navigator.com+1

7. Documentation Requirements

A robust process validation package usually includes:

• Process development reports (Stage 1)
• Risk assessments (FMEA / FMECA / HACCP etc.)
• Equipment and utility qualification documents
• Process Validation Master Plan (PVMP)
• PPQ protocols and reports
• Data sets, calculations, trend charts, capability analysis
• CPV / ongoing verification procedures and periodic review reports
• Change control, CAPA, deviation investigations related to PV

8. Roles & Responsibilities

• Manufacturing / Production
  • Execute batches as per approved procedures and PV protocols
  • Record data accurately, report deviations
• Quality Control (QC)
  • Perform analytical tests (raw, in-process, finished product samples)
  • Participate in method validation and transfers
• Validation / Technical / MS&T
  • Design PV strategy, protocols and sampling plans
  • Perform data analysis and reporting
• Quality Assurance (QA)
  • Approve PVMP, protocols and reports
  • Oversee lifecycle management, CPV, and compliance

9. Sample FAQs for Your Website

Q1. Why is process validation required in the pharmaceutical industry?
Because regulators (FDA, EMA, etc.) require scientific evidence that a manufacturing process can consistently produce quality products. Process validation links development data with commercial performance and ensures patient safety and product efficacy. U.S. Food and Drug Administration+2European Medicines Agency (EMA)+2

Q2. How many batches are needed for process validation?
Typically, companies use three consecutive successful PPQ batches per product/site as a minimum, unless a different, risk-based, scientifically justified approach is accepted by regulators. Guidelines do not fix a universal number but expect a justification based on process knowledge and risk.

Q3. What is the difference between process qualification and continued process verification?

• Process Qualification (Stage 2) demonstrates that the process, equipment and facility can produce acceptable product at commercial scale.
• Continued Process Verification (Stage 3) is the ongoing monitoring of process performance during routine production to ensure the process remains in a state of control. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2

Q4. How do ICH Q8, Q9 and Q10 relate to process validation?

• ICH Q8: Science- and risk-based pharmaceutical development (QTPP, CQAs, design space).
• ICH Q9: Quality risk management principles and tools used across the lifecycle.
• ICH Q10: Pharmaceutical Quality System model supporting lifecycle, CPV and continual improvement.
  Together, they support the modern, lifecycle-based approach to process validation. IntuitionLabs+3European Medicines Agency (EMA)+3Ideagen+3

Q5. Is retrospective validation still acceptable?
Retrospective validation may exist for long-standing, well-understood processes with extensive historical data, but current regulatory expectation is a lifecycle approach with prospectively planned validation and continued process verification.