Process Validation ensures that pharmaceutical manufacturing processes consistently produce products meeting predetermined quality attributes. PrimeGMP provides end-to-end process validation services based on FDA, EU, WHO, and ICH-aligned lifecycle principles, covering Stage 1 (Process Design), Stage 2 (Process Qualification), and Stage 3 (Continued Process Verification – CPV).

Objectives of Process Validation

• Demonstrate process consistency and reproducibility
• Confirm product CQAs & CPPs remain under control
• Establish validated operating ranges and worst-case parameters
• Verify equipment, utilities, and controls perform consistently
• Ensure regulatory readiness and lifecycle alignment
• Strengthen the organization’s quality and compliance framework

Process Validation Lifecycle

1. Stage 1 – Process Design

• Review of product & formulation development data
• Identification of CPPs, CQAs & CMAs
• Risk assessment (FMEA, Fishbone, Ishikawa)
• Development of control strategy
• Process scale-up and trial evaluation
• Identification of worst-case parameters

2. Stage 2 – Process Qualification (PPQ)

Includes Equipment / Facility / Utility readiness

• PPQ Protocol preparation
• Verification of equipment qualification (DQ–IQ–OQ–PQ)
• Review of raw material controls
• Verification of operator training & readiness
• Controlled batch manufacturing runs
• Testing of in-process controls, yield, uniformity, and consistency
• Demonstration of batch-to-batch reproducibility
• Statistical evaluation of PPQ batches
• Trending of critical parameters & test results

3. Stage 3 – Continued Process Verification (CPV)

• Routine monitoring of process data
• Trending of CPPs, CQAs, yields & quality parameters
• Verification of statistical control (Cp, Cpk, control charts)
• Annual product quality review data integration
• Review of deviations, OOS, OOT & CAPA
• Lifecycle assessment for periodic revalidation

Support for Various Dosage Forms

• Oral solid dosage (tablets, capsules)
• Sterile injections (SVP, LVP, lyophilized)
• Dry powder injections
• Ointments & creams
• Liquid orals & suspensions
• API manufacturing
• Biotech & fermentation processes

Documentation Provided

• Process Validation Master Plan (PVMP)
• Risk assessments
• PPQ Protocols
• Executed PPQ batch documentation
• Statistical analysis reports
• CPV plans & ongoing monitoring templates
• Final Process Validation Reports
• Revalidation strategy & recommendations

Regulatory Standards Followed

• USFDA Process Validation Guidance – 2011
• EU GMP Annex 15 (Qualification & Validation)
• ICH Q8 (Pharmaceutical Development)
• ICH Q9 (Quality Risk Management)
• ICH Q10 (Pharmaceutical Quality System)
• WHO TRS 1019
• PIC/S Guidance (PI 006)

Why Choose PrimeGMP for Process Validation?

• Strong experience in PPQ execution across multiple dosage forms
• Expertise in lifecycle-based validation aligned with global regulators
• Robust statistical evaluation & trending capability
• End-to-end integration with equipment, utility, and cleaning validations
• Clear, concise, audit-ready documentation
• Practical problem-solving during PPQ & CPV failures