Compliance audit
and GMP FormAction™
GMP compliance audit, pre-approval inspection (PAI) and inspection readiness, plus FormAction™ for your teams from an approved training organization.
Standards EMA-Annex 1 · GMP · cGMP · FDA · Health Canada · HACCP · ISO 22000
Challenges we solve
Are you at one of these stages?
01
An inspection is coming up
The FDA, Health Canada or a European authority is coming soon: you want to know your gaps before they do.
Let’s talk about this challenge
02
Recurring findings
The same observations from one inspection to the next: you need to find the cause, not just fix the symptoms.
Let’s talk about this challenge
03
A new site to certify
A new unit needs its license or its compliance certification.
Let’s talk about this challenge
04
A team to train
Your teams need to master GMP, with recognized FormAction™ courses.
Let’s talk about this challenge
We assess your site, processes and documentation against GMP, then prepare for the inspection with you: before, during and after. We also support compliance certification, licenses and chemical or biological containment permits.
PBE Expert is a CPMT-approved training organization (No. 0059104). Our experts have been CIPE trainers since 2013, and their FormAction™ courses earn hours recognized by the Ordre des ingénieurs du Québec.
What you get
Results you can show.
An audit report with every finding ranked by risk
A dashboard for each area
A corrective and preventive action plan
Inspection readiness, before, during and after
Tailored GMP FormAction™ courses, recognized by the CPMT
Spotting over-compliance, which costs money without adding anything
What the service includes
The common core for every industry we serve.
Service sheet
Compliance audit and GMP FormAction™
Page 1 of 1
- 01EMA-Annex 1 complianceGap analysis in 13 chapters, using the PBE Expert method
- 02GMP compliance audit and pre-approval inspection (PAI)
- 03Inspection readiness plan and procedureBefore, during and after
- 04Corrective and preventive actionsCAPA, RAPA, GAPA
- 05Remediation plans
- 06Setting up and managing a change control system
- 07Continuous improvement and supplier qualification quality audits
- 08Drafting and review of quality agreements (QAA)
- 09Drafting the Site Master File (SMF)
- 10GMP FormAction™PBE Expert, CPMT-approved training organization (No. 0059104), CIPE and OIQ
Approved by
The PBE Expert team
By industry
Every industry adds its own requirements. Here is what comes on top of the common core, industry by industry.
Pharmaceutical2 items
- Site GMP compliance certification, licenses and chemical containment permits
- Procedure review and writing (SOPs)
Biotechnology and vaccines1 items
- Site GMP compliance certification, licenses and biological containment permits
EU-GMP therapeutic and medical cannabis2 items
- Site GMP compliance certification and licenses
- FormAction™: PBE Expert, CPMT-approved training organization (No. 0059104), CIPE and OIQ
Hospitals and pharmacies1 items
- Site GMP compliance certification, licenses and chemical containment permits
Fine chemicals and APIs1 items
- Site GMP compliance certification, licenses and permits
Food9 items
- HACCP, ISO 22000, GFSI, SQF, ISO 9001 compliance certification
- Inspection readiness procedure: before, during and after
- Remediation and hazard prevention plans (CCP)
- Management of nonconforming products
- Data and critical control point (CCP) recording and traceability systems, Industry 4.0
- Continuous quality improvement
- Internal audit and food safety evidence
- Implementing corrective and preventive actions: CAPA, RAPA, GAPA
- Inspection audit and food safety evidence
Our audit checklist
Aseptic manufacturing: 78 checkpoints.
For sterile injectable products, our checklist covers 10 areas, from receipt of materials to the quality system. Each point links the regulatory requirement, good practice and the most common finding, with its risk level and the recommended corrective action.
- 33 critical Direct impact on sterility or patient safety
- 40 major Significant gap in the quality system
- 5 minor Isolated gap, to address through continuous improvement
Materials and components
Receipt, sampling, release, weighing
8 points : 3 critical, 5 major, 0 minor
Quality control laboratory
Methods, sterility, out-of-specification results, data integrity
7 points : 4 critical, 3 major, 0 minor
Quality documentation
Procedures, batch records, archiving, FormAction™
6 points : 1 critical, 4 major, 1 minor
Aseptic manufacturing
Gowning, media fill, interventions, contamination control strategy
8 points : 7 critical, 1 major, 0 minor
Cleanrooms and HVAC
Classification, pressures, unidirectional flow, airlocks
10 points : 4 critical, 4 major, 2 minor
Environmental monitoring
Viables, particles, trends, excursions
7 points : 3 critical, 3 major, 1 minor
Critical utilities
Purified water, water for injection, clean steam, gases, compressed air
7 points : 2 critical, 4 major, 1 minor
Sterilization
Autoclaves, SIP, CIP, depyrogenation
8 points : 3 critical, 5 major, 0 minor
Qualification and validation
Equipment, process, cleaning, computerized systems
8 points : 2 critical, 6 major, 0 minor
Quality system
Change control, deviations, CAPA, suppliers
9 points : 4 critical, 5 major, 0 minor
We also flag over-compliance: requirements exceeded for no reason, which cost a lot without adding anything to product safety.
You receive a dashboard for each area, with the compliant points, the gaps and the corrective action plan.
EU GMP (Annexes 1, 11 and 15) · FDA 21 CFR Parts 210 and 211 · ICH Q8, Q9 and Q10 · PIC/S · ISO 14644
Frequently asked questions
What people ask us.
Which standards do you cover?
EU GMP (Annexes 1, 11 and 15), the FDA (21 CFR Parts 210 and 211), Health Canada, the ICH Q8, Q9 and Q10 guidelines, PIC/S and ISO 14644.
Are your FormAction™ courses recognized?
Yes. PBE Expert is a CPMT-approved training organization (No. 0059104), and our FormAction™ courses earn hours recognized by the Ordre des ingénieurs du Québec.
Can you audit outside Canada?
Yes. Our teams work in North America, Europe and Africa.
Does the audit also flag over-compliance?
Yes: we also point out requirements exceeded for no reason, which cost a lot without adding anything to product safety.
Let’s talk about your project.
A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.