Audits & Gap Assessments
GMP inspection readiness and preparation
Inspections go best when the site is compliant and the team can show it. We help you prepare both: by finding and closing gaps through mock inspections, and by preparing people, documents and logistics for the inspection itself.
- Typical inspections Importing authority, WHO, EU/PIC/S, US FDA, customer
- Typical inputs Inspection notice, site master file, previous reports
- You receive Mock inspection report, readiness plan and coaching
Overview
About Inspection Readiness
Readiness is not about rehearsing answers. It is about having systems that comply, records that can be retrieved quickly and people who can explain what they do and why. A mock inspection run by experienced auditors is the most realistic way to test all three.
After the mock inspection we help close priority gaps, prepare storyboards for complex topics, set up front-room and back-room arrangements and coach subject-matter experts on presenting information clearly and accurately.
Use cases
When this service helps
First inspection by a new authority
Prepare for an importing authority’s GMP inspection.
Pre-approval inspections
Prepare for inspections linked to a new product application.
Routine re-inspections
Check that previous commitments are closed and systems are current.
Major customer audits
Prepare for audits by key partners.
Scope
What the service covers
- Mock inspection against the relevant standard
- Review of previous observations and commitment status
- Storyboards for complex topics such as investigations or validation
- Front-room and back-room organisation and document request handling
- Subject-matter expert coaching and inspection etiquette
- Readiness checklist and daily inspection support plan
Who does what
Globaxa prepares your teams and can support from the back room during an inspection if requested; we do not represent the site in place of its own personnel.
What is a storyboard?
A short, factual summary of a complex topic — for example a major investigation or a validation programme — that allows a subject-matter expert to explain it clearly and point to the supporting records.
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.
- PlanInspection scope, likely focus areas and timeline are reviewed.
- Mock inspectionAn inspection-style audit of systems, facilities and records.
- Close gapsPriority findings are addressed before the inspection.
- Prepare peopleStoryboards, logistics and coaching for the inspection team.
Deliverables
What you receive
Mock inspection report
Findings graded by inspection risk.
Readiness plan
Actions and owners up to the inspection date.
Storyboards and coaching
Prepared narratives and trained subject-matter experts.
Technical basis
Guidelines we work to
- Relevant GMP standardWHO GMP, PIC/S PE 009, EU GMP, 21 CFR 210/211 or Revised Schedule M, as applicable.
- Inspectorate proceduresPublished inspection procedures and aide-memoires indicate typical areas of focus.
What we need from you
- Inspection notification and scope (if known)
- Site master file and product list
- Previous inspection reports and CAPA status
- Key SOPs and recent quality metrics
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 manufacturing sites before or after product registration, often against WHO GMP. Some accept inspections by other recognised authorities. We tailor preparation to the inspecting authority’s known practices.
FAQs
Inspection Readiness: frequently asked questions
How far ahead should we start?
Ideally two to three months before an announced inspection, so that gaps found in a mock inspection can be closed.
Can you support during the inspection?
Yes, from the back room — helping to find documents, review responses before they are given and track requests.
Is a mock inspection the same as a gap assessment?
A mock inspection simulates the inspection experience; a gap assessment measures compliance against a new standard. Many sites do both.
Talk to us about Inspection Readiness
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