Audits & Gap Assessments
Pharmaceutical supplier audits
Manufacturers are responsible for the quality of what they buy. A supplier audit gives you documented evidence that an API, excipient, packaging or service provider operates to the standard you need — and identifies risks before they reach your product.
- Standards ICH Q7, EU GMP Part II, WHO GMP, IPEC-PQG, ISO 15378
- Typical inputs Supplier details, materials supplied, quality agreement
- You receive Audit report with graded observations and a recommendation
Overview
About Supplier Audits
GMP requires manufacturers to qualify their suppliers and keep that qualification current. Regulators increasingly look at supplier oversight during inspections, particularly for APIs and critical excipients. A well-planned audit — focused on the risks of the specific material — is the strongest form of evidence.
We plan each audit around what the supplier provides and how it affects your product, carry it out on site or remotely, and report findings in a format that fits your supplier qualification process.
Use cases
When this service helps
New supplier qualification
Audit before approving a new API or excipient source.
Periodic re-qualification
Routine audits according to your supplier risk ranking.
Supply problems or complaints
Investigate recurring quality issues with a supplier.
Dossier and DMF support
Confirm that the API manufacturer’s practices match the registered information.
Scope
What the service covers
- Risk-based audit planning for the material or service supplied
- Quality system, documentation and data integrity review
- Facility, equipment and utility assessment
- Production, packaging and laboratory controls
- Change control, deviations, out-of-specification handling and complaints
- Supply-chain traceability and subcontractor management
- Comparison with the registered dossier or DMF where relevant
Who does what
The decision to approve or reject a supplier remains with your quality unit. Globaxa provides an independent audit and recommendation.
How often should suppliers be audited?
Frequency should follow risk: criticality of the material, supplier history and complaint data. Many companies audit API manufacturers every two to three years, with higher-risk suppliers more often.
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.
- PlanScope, standard and agenda are agreed with you and the supplier.
- PrepareWe review pre-audit documents and questionnaires.
- AuditFacility tour, interviews and record review.
- ReportObservations are graded and referenced to requirements.
- Close outWe review the supplier’s CAPA response if requested.
Deliverables
What you receive
Audit report
Scope, findings graded by severity, and overall recommendation.
CAPA tracker
A table of observations for the supplier’s responses.
Executive summary
One-page conclusion for your supplier management records.
Technical basis
Guidelines we work to
- ICH Q7GMP guide for active pharmaceutical ingredients.
- EU GMP Chapter 5 and Part IIExpectations for supplier qualification and API manufacture.
- ICH Q10Pharmaceutical quality system, including oversight of outsourced activities and purchased materials.
- IPEC-PQG GMP Guide and ISO 15378Recognised GMP standards for excipients and primary packaging materials.
What we need from you
- Supplier name, site address and materials or services supplied
- Quality agreement and specifications
- Supplier questionnaire, previous audit reports and certificates
- Known issues, complaints or deviations
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
EU and PIC/S inspectorates expect documented supplier audits for APIs, often through the qualified person’s declaration. WHO-GMP and US FDA inspections also examine supplier oversight. Importing authorities in Africa and Asia frequently ask for evidence of API supplier GMP status during registration.
FAQs
Supplier Audits: frequently asked questions
Do you audit outside India?
Supplier audits can be arranged in other countries; feasibility, travel and timing are confirmed for each request.
Can you audit against our own standard?
Yes. We can use your supplier quality standard or questionnaire in addition to the GMP reference.
Will the supplier see the report?
That is your decision. We typically provide the observations to the supplier for CAPA while the full report goes to you.
Talk to us about Supplier Audits
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