Audits & Gap Assessments
GMP and quality-system gap assessments
A gap assessment shows where your site stands against the GMP standard your target markets apply, and what it will take to close the difference. We assess facilities, systems and records, and give you a prioritised plan rather than a list of everything that could be better.
- Standards WHO GMP, EU GMP, PIC/S PE 009, 21 CFR 210/211, Revised Schedule M
- Typical inputs Site master file, SOP index, recent audit reports
- You receive Gap report and prioritised remediation roadmap
Overview
About Gap Assessments
Moving to a new market often means meeting a different or stricter GMP standard. Domestic changes such as India’s Revised Schedule M have the same effect. A structured gap assessment compares your current state with the target standard, clause by clause, and identifies what matters most for product quality and regulatory risk.
We focus on proportionate, practical solutions and help you sequence the work — facility changes, procedures, training and evidence — so that progress is visible and defensible.
Use cases
When this service helps
Preparing for an export market
Assess against WHO GMP or PIC/S before an importing authority’s inspection.
Revised Schedule M compliance
Identify and prioritise the changes required for Indian GMP.
Before a site acquisition
Due-diligence assessment of a site’s compliance status.
After repeated observations
Understand systemic weaknesses behind recurring findings.
Scope
What the service covers
- Pharmaceutical quality system and management review
- Premises, equipment, utilities (HVAC, water, compressed air) and qualification status
- Production, packaging and contamination control
- Quality control laboratory, stability and data integrity
- Validation programme, including process and cleaning validation
- Documentation, training, deviations, CAPA and change control
- Prioritised remediation plan with indicative effort
Who does what
Facility engineering, construction and equipment qualification execution are carried out by your teams or specialist vendors. Globaxa assesses, prioritises and reviews progress.
How does a gap assessment differ from an audit?
An audit checks compliance with a standard you already claim to meet. A gap assessment measures the distance to a standard you are moving towards, and focuses on planning how to close it.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Choose the standardAgree the target standard and the products and areas in scope.
- Review documentsSite master file, SOPs and previous reports are reviewed in advance.
- Assess on siteFacility walk-through, interviews and record sampling.
- PrioritiseGaps are ranked by product-quality and regulatory risk.
- PlanA sequenced remediation roadmap is agreed with your management.
Deliverables
What you receive
Gap assessment report
Findings referenced to the standard, with evidence and risk rating.
Remediation roadmap
Prioritised actions, suggested owners and sequencing.
Management briefing
A summary presentation for senior decision-makers.
Technical basis
Guidelines we work to
- WHO GMP (TRS 986 Annex 2 and related annexes)Main principles for pharmaceutical products, used by many importing authorities.
- PIC/S PE 009 and EU GMPHarmonised GMP guide used by PIC/S member inspectorates.
- 21 CFR Parts 210 and 211US current good manufacturing practice regulations for finished pharmaceuticals.
- Revised Schedule M (India)Notified in December 2023 to align Indian GMP more closely with WHO GMP. Compliance timelines for smaller manufacturers were extended; check current CDSCO notifications for your site.
What we need from you
- Site master file and organisation chart
- SOP index and validation master plan
- Recent internal, customer and regulatory audit reports
- Products made, target markets and planned changes
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Many authorities in Africa and Asia inspect foreign manufacturers against WHO GMP or PIC/S standards, and some recognise inspections by stringent authorities. Requirements differ for each market, so the target standard is agreed at the start.
FAQs
Gap Assessments: frequently asked questions
How long does a gap assessment take on site?
For a typical single-site oral solid dosage facility, two to four days on site is common, plus document review. Larger or sterile sites need longer.
Can you help implement the remediation plan?
Yes. We can review procedures, train teams and check progress, while engineering work is carried out by your vendors.
Do you assess against Revised Schedule M?
Yes. We assess against the revised requirements and help you prioritise what to address first.
Talk to us about Gap Assessments
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST