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Pharma QA Consulting
#QAConsulting #GapAssessment #CAPA

Close Compliance Gaps - Before Auditors Do.

Independent QA reviews, gap assessments, and CAPA support - structured to close findings fast and hold up in any inspection.

PHARPRO pharmaceutical QA consulting delivers independent gap assessments, SOP development, CAPA support, supplier qualification, pharmaceutical procurement consulting, and inspection readiness reviews aligned with FDA 21 CFR Parts 210/211, EU GMP, and WHO requirements. Based in Amman, Jordan - serving pharmaceutical companies across the MENA region including the UAE, Saudi Arabia, and Egypt. Gap assessments typically completed in 2–3 weeks.

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FDA 21 CFR Parts 210/211 EU GMP Guidelines ICH Q10 Data Integrity
What We Deliver

Inspection-ready QA support

From rapid gap assessments to sustained QA programme management - every engagement closes findings and builds lasting compliance capability.

Regulatory Gap Assessment

System-wide comparison of your current quality practices against FDA, EU GMP, and WHO requirements - prioritised by inspection risk and remediation effort.

SOP Review & Development

Evaluation of existing standard operating procedures against current regulatory expectations - with gap remediation, rewriting, and approval cycle support.

CAPA Management

Root cause analysis, corrective and preventive action planning, implementation tracking, and effectiveness verification - structured to satisfy inspector scrutiny.

Data Integrity Audit

Review of data governance practices against ALCOA+ principles - covering raw data handling, audit trails, access controls, and electronic records management.

Inspection Readiness Review

Pre-inspection mock assessment simulating regulatory agency expectations - identifying vulnerabilities and coaching your team for confident inspection performance.

QA Programme Assessment

Holistic review of your quality management system - organisational structure, batch release, change control, deviations, and continuous improvement mechanisms.

Our Approach

How a gap assessment works

A structured, four-step process that gives you a clear picture of your compliance position and a concrete path forward.

1

Scoping Call

We define the assessment boundary - which systems, sites, processes, and regulations are in scope. No charge, no obligation.

2

Document Review & Remote Assessment

Review of SOPs, batch records, deviation logs, CAPA register, validation records, and change control documentation - remotely, within 1–2 weeks.

3

Gap Report & Risk Prioritisation

Detailed written report mapping each finding to the relevant regulation, with a risk rating (critical / major / minor) and recommended remediation action.

4

Remediation Support

Optional: PHARPRO supports closure of findings - rewriting SOPs, implementing CAPA, and verifying effectiveness to get you inspection-ready.

FAQ

Common QA questions

A PHARPRO QA gap assessment reviews your current quality systems against applicable regulatory requirements - FDA, EU GMP, and WHO. It identifies missing documentation, procedural weaknesses, and compliance gaps, then prioritises findings by inspection risk.
A focused gap assessment typically takes 2–3 weeks. PHARPRO delivers a prioritised finding report with CAPA recommendations, and can support remediation directly. Critical findings are escalated immediately.
Yes - inspection readiness support is one of our most requested services. We can mobilise within days, conduct a rapid pre-inspection review, and prepare your team with a mock inspection walk-through and response coaching.
A QA gap assessment is conducted by an independent external expert who benchmarks your quality systems against regulatory requirements - delivering a prioritised finding report with remediation recommendations. An internal audit checks compliance against your own SOPs. PHARPRO gap assessments simulate how an external inspector would view your operations, identifying risks your own team may overlook.
PHARPRO data integrity reviews are benchmarked against FDA's 2018 Data Integrity Guidance, MHRA GxP Data Integrity Guidance, WHO Technical Report 1010 Annex 4, and EU GMP Chapter 4 and Annex 11. The review covers ALCOA+ principles, audit trail controls, system access management, and backup and recovery procedures.
PHARPRO supports CAPA development from root cause analysis through to effectiveness check using structured methodologies including Ishikawa analysis and the 5-Why technique - producing a corrective action plan, implementation evidence, and verification record formatted to FDA, EU GMP, and ICH Q10 expectations.
An inspection readiness assessment is a structured, independent review of your quality systems, documentation, and operational practices - conducted as if by an FDA, EU GMP, or WHO inspector. PHARPRO evaluates SOP coverage, batch record quality, deviation and CAPA management, training records, data integrity controls, and laboratory practices, then delivers a prioritised report with remediation guidance before the real inspection takes place.
A focused QA gap assessment typically takes 2–3 weeks from kick-off to final report delivery. Scope, site size, and number of product types affect duration. PHARPRO provides a clear timeline in the project proposal. Urgent pre-inspection assessments can be mobilised faster - contact us to discuss your timeline.
ALCOA+ is the data integrity framework used by FDA, MHRA, EU GMP, and WHO to define the attributes all GxP data must possess. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. The '+' adds Complete, Consistent, Enduring, and Available. PHARPRO data integrity audits assess your systems and processes against every ALCOA+ attribute.
An external QA consultant adds independent perspective that internal teams cannot provide. Regulators expect companies to identify and close gaps proactively - an outside reviewer simulates the inspector's viewpoint and surfaces blind spots that familiarity prevents your own team from seeing. PHARPRO works alongside internal QA teams to strengthen existing systems, not replace them.
A deviation is an unplanned departure from an approved procedure or specification - documented, investigated, and risk-assessed. A CAPA (Corrective and Preventive Action) is the structured response: the Corrective Action addresses the immediate problem, and the Preventive Action eliminates the root cause to prevent recurrence. PHARPRO supports the full CAPA lifecycle from root cause analysis through effectiveness check, formatted to FDA, EU GMP, and ICH Q10 expectations.
A PHARPRO pharmaceutical QA gap assessment is priced based on scope - systems reviewed, site size, and applicable regulatory frameworks. A focused gap assessment covering core GMP areas (documentation, CAPA, training, batch records) typically ranges from $3,000–$8,000 USD. Pre-inspection readiness assessments and full-site QA programme reviews are scoped individually. PHARPRO provides a fixed-price proposal with a clear deliverable list - contact us for a free scoping call.
PHARPRO is a specialist pharmaceutical QA consulting firm based in Amman, Jordan, delivering gap assessments, inspection readiness reviews, CAPA support, and SOP development across the MENA region - Jordan, UAE, Saudi Arabia, Egypt, and Kuwait. All engagements are aligned with FDA, EU GMP, WHO, and applicable national authority (JFDA, SFDA, MOH) requirements. Remote delivery is available for all documentation-focused services.
Responding to an FDA 483 or Warning Letter requires a structured CAPA response that addresses root cause - not just the surface finding. PHARPRO supports 483 and Warning Letter responses by conducting independent root cause analysis, drafting CAPA commitments with realistic timelines, reviewing supporting documentation, and formatting the response to meet FDA's expectations for completeness and corrective action specificity. Contact us immediately if you have received a 483.
A WHO prequalification inspection assesses whether a pharmaceutical manufacturing site meets WHO GMP requirements covering quality systems, facilities, equipment, documentation, production, QC, and distribution. Inspectors review SOPs, batch records, validation files, deviation logs, and CAPA systems - and conduct facility walk-throughs. PHARPRO's inspection readiness support includes a mock WHO inspection, gap identification, documentation remediation, and team preparation before the actual inspection visit.
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Related Insights

Go deeper on pharmaceutical QA

In-depth guides from Mohammad Awawdeh on GMP gap assessments, data integrity, CAPA management, and inspection readiness.

QA Guide
GMP Gap Assessment: How to Prepare and What to Expect
What a gap assessment covers, how findings are prioritised, and how to use the results to drive remediation.
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Data Integrity
Data Integrity in GMP: FDA and MHRA Requirements
ALCOA+ principles, audit trail requirements, and the most common data integrity findings in pharma inspections.
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CAPA
CAPA Management in Pharma: From Root Cause to Closure
How to structure a CAPA, conduct effective root cause analysis, and produce closure documentation that satisfies regulators.
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Inspection Readiness
Inspection Readiness: Preparing for an FDA or EU GMP Audit
How to run a mock inspection, identify critical gaps, and ensure your team can respond confidently under audit.
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Compliance
FDA 21 CFR Part 11: Data Integrity Requirements
Electronic records, e-signatures, and audit-trail requirements every regulated system must meet.
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Related Services

Complete compliance support

Computerized System Validation

End-to-end CSV - from URS and risk classification through IQ/OQ/PQ protocols and Validation Summary Report.

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CQV & Thermal Mapping

Equipment commissioning, qualification, and validation plus temperature mapping for controlled environments.

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GMP Training Programmes

Instructor-led GMP, data integrity, and CSV training - online and on-site for pharmaceutical teams across MENA.

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From the Compliance Library

Related Reading

What Is a GMP Gap Assessment?

What a gap assessment covers, when to conduct one, and how PHARPRO structures assessments to deliver actionable CAPA plans.

Read the guide →

CAPA Management in Pharma

Regulatory requirements, root cause analysis methods, effectiveness checks, and how to avoid the most common CAPA failures.

Read the guide →

FDA Warning Letter Response

Step-by-step guide to responding — structure, timelines, commitments, and how to demonstrate sustainable correction.

Read the guide →

Inspection Readiness Guide

A 7-step framework to prepare your pharmaceutical site for an FDA, EU GMP, or national authority inspection.

Read the guide →

Why PHARPRO

Practical quality and inspection readiness support with audit-defensible outputs

Hands-on deliveryWork is scoped around your systems, documents, people and regulatory market.
Clear deliverablesDefined responsibilities, review cycles, acceptance criteria and closure evidence.
Risk-based approachEffort is focused on product quality, patient safety and data-integrity risk.
MENA reachSupport across Jordan, UAE, Saudi Arabia and Egypt.

PHARPRO aligns each engagement with the regulations and guidance applicable to the client’s product, market and quality system. Final responsibility and approval remain with the regulated company.

Free Download: The 50-Question Pharma Compliance Checklist 50 pre-inspection questions covering QA, gap assessment, data integrity, CSV & CAPA - aligned with FDA & EU GMP. Free, instant access.
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Based in Amman, Jordan · Serving clients worldwide · Response within one business day