Upcoming cGMP Regulatory Inspection?
Get Audit Ready in 3 Weeks, Guaranteed.
Our GMP Health Check program allows you to identify cGMP, Annex 1 and ISO 22716 compliance risks fast with tailored recommendations and audit playbooks.
Instant access. Full support. No guesswork.
5 Outstanding Benefits of our GMP Health Check Program
GMP Health Check tailored to your site with clear risk ranking.
Ready-to-use Annex 1, QMS, and Facility Compliance Assessments.
All templates you need to achieve an EMA-compliant audit package.
Expert support throughout to drive rapid and sustainable compliance.
Bonus site licence to CPD-Certified GMP and Quality System training.
Who This is Program For?
Our 3-Week GMP Health Check Program can help if this is you:
The Problem
Pharmaceutical companies with an upcoming regulatory audit and struggling to identify cGMP gaps in their current facility, utilities, process or QMS.
The Person
Site Heads and senior leaders in Quality Assurance, Engineering, Quality Control and Manufacturing that want to take a proactive approach to cGMP compliance.
The Goals
To quickly assess the level of compliance to cGMP, EU Annex 1 or ISO 22716 and build an audit-ready remediation plan to sail through the next inspection.
The Modality
This program takes a holistic approach across Sterile, Non-Sterile, ATMP and Cosmetic manufacturing, tailored to your specific site requirements.
The Company
Suitable for primary pharmaceutical manufacturers, global Contract Manufacturing Organizations (CMO), cosmetic or nutraceutical companies.
The Bandwidth
Pharmaceutical companies committed to quality but lacking regulatory experience or bandwidth and needing compliant and audit-ready results fast.
What You Get – Day 1 Access
Everything you need to build an audit-ready Quality Management System:
3 Week Project Plan
Complete, structured project plan to deliver with confidence. Built to FDA / EMA expectations. Saves time, facilitates internal alignment and puts you in control from Day 1.
EMA-Compliant Quality Updates
​SOPs, policies, protocols, validation templates, and QMS links. All pre-formatted, EU Annex 1 aligned. Removes ambiguity and ensures your system can withstand regulatory scrutiny.
Expert Support
Direct access to Pharmalliance GMP specialists through the full process. Includes all the support you need to identify gaps, create documentation and project manage the effort.
Risk Assessment Toolkit
​Rapid tools to identify, prioritise and map cGMP, Annex 1 or ISO 22716 risks. Includes facility flow maps, risk matrices, and cleanroom failure libraries to get instant visibility and action alignment.
Annex 1 Compliance
Expert Annex 1 and Microbial Control FMEA gap analysis performed on your facility and process, identifying gaps, prioritising remediation activities and ensuring compliance with regulatory expectations.
Audit-Ready Documentation
​Instant access to audit ready library of cGMP and contamination control documentation. Every tool formatted for inspection use, no guesswork, just results you can present confidently.
Corporate Quality Plan
Fully developed compliance roadmap linked to audit ready cGMP Quality Remediation plan. Structured for executive review and ready for submission to regulators.
CPD-Certified Training Program
Ready-to-deploy GMP and Contamination Control for QA, QC, Engineering and Manufacturing. SCORM-compatible and audit-ready with assessments, training matrix, and certification for inspection evidence.
Bonus Compliance Tools
​Includes 30+ SOPs, FDA 483 examples, audit checklists, risk assessments, 100 licenses for CPD training, and CCS templates. Value of €50k — all included with your site license at no extra cost.
3-Week Execution Plan
Project Planning
You Get:
-
Collaboration to define of "What success looks like"
-
Agreement of project Scope, Timeline and Schedule
-
Detailed project plan with Charter, Plan and RACI matrix
-
Stakeholder Engagement
-
Data gathering and documentation reviews
-
Project governance definition
Detailed cGMP Gap Assessment
You Get:
-
Corporate-Level cGMP gap assessment
-
SOP Gap Identifier Tool (auto cross-check vs regs)
-
Prioritised risk-based Remediation Plan based on identified QMS gaps
-
Updated audit-ready cGMP Strategy document + expert support
Detailed Gap Analysis
You Get:
-
cGMP, EU Annex 1 and Microbial Control FMEA of end to end process
-
Visual dashboards to easily understand risk portfolio
-
Facility Risk Map (people, material, product, waste)
-
GxP Process Criticality Matrix
-
Environmental Monitoring and Utilities Risk Analysis​
Inspection Readiness Pack
You Get:
-
Finalised GMP Health Check Program Documents
-
Inspection Walkthrough Deck for identified major gaps
-
​cGMP Reference Binder (with model answers)
-
SOP-to-Reg Clause Mapping Tool
-
Mock Inspection Readiness Checklist
In Person Site Visit
You Get:
-
Expert on site Facilities, Utilities, Process, Cleaning, Sterilization audit
-
Documentation review
-
Finalization of risk assessments
-
Site leadership team presentation mapping current cGMP level to future level
-
cGMP and CCS training session
-
Definition of next steps
Training & Behaviour Change
You Get:
-
CPD-Certified Training: GMP Fundamentals, Contamination Control Excellence Program
-
35 Microlearning Modules (24/7, online and SCORM-ready)
-
Training Matrix + Role-Based Modules
-
Operator Training Assessments + Audit-Ready Records
Testimonials
Senior Director, Global CDMO
"The experience and knowledge of the Pharmalliance team was outstanding and helped much overcoming misunderstandings and knowledge gaps on our side."
QP + Quality Head, Vaccines
"Pharmalliance helped with a CCS development project where there was a great deal of pressure to go very quickly. They were very effective strategizing what needs to be done."
QA Manager, Sterile OTC
“We faced numerous technical challenges, but their service delivered brilliant solutions. Their hands-on approach meant we felt supported throughout the project. ”
Included Bonuses
1
Internal Audit Toolkit
We provide all the templates that you need to identify your cGMP / Annex 1, and Microbial Control risks. These risks are assigned a Risk Priority Number (RPN) and linked to CAPA's.
2
CPD Training Modules
Our CPD Certified cGMP Fundamental and Contamination Control Program elevate your sites knowledge and compliance level quickly. These training programs are available 24/7.
3
Full Site Access
Remediation should not be confined to a select few individuals. For lasting change the whole site gets access to our CPD Certified material for 1 year post purchase.
Some of our happy clients
