GMP Compliance Problems are Increasing
Regulatory inspections are becoming more demanding.
Many pharmaceutical sites struggle to identify hidden compliance gaps before inspection.
Some common problems include:
Repeat Deviations
Repeat deviations often indicate unresolved systemic failures in processes, controls or quality oversight.
Contamination Events
Contamination events frequently reveal weaknesses in contamination control strategy, facility design or operator practices.
Facility Deficiencies
Facility deficiencies can create hidden risks in HVAC, utilities and process environments that compromise GMP compliance.
When These Issues are Not Addressed
There can be serious consequences for a pharmaceutical site, including:
Regulator Observations
Regulatory observations often expose underlying quality system failures that were not detected during internal oversight.
Warning Letters
Warning letters signal significant regulatory concern and typically require extensive remediation across quality systems.
Recalls and Shutdowns
Product recalls or site shutdowns can occur when unresolved compliance risks compromise product quality or patient safety.
You Do Not Have to Navigate Regulatory Pressure Alone.
Pharmalliance works alongside pharmaceutical manufacturing teams to stabilise operations and restore compliance.
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Our specialists support:
• QA
• QC
• Engineering
• Manufacturing
• Site leadership
We support companies across sterile, non-sterile, ATMP, OSD and cosmetic manufacturing environments across Europe, the UK and the United States.
Our Proven 3-Step Process
We have implemented this proven process for global pharma companies facing regulatory pressure:
Identify Compliance Risks
Structured GMP assessments across facility, utilities, processes and quality systems.
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Examples:
• Annex 1 assessments
• GMP health checks
• facility gap assessments
• quality system reviews
Build a Remediation Plan
Prioritised remediation actions aligned with EU GMP, FDA and Annex 1 expectations.
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Examples:
• remediation roadmaps
• CAPA frameworks
• contamination control strategy
• validation master plans
Execute and Restore Compliance
Onsite expert support to stabilise operations and prepare for regulatory inspection.
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Examples:
• onsite remediation teams
• SOP implementation
• operator training
• mock inspections
Core Services
Pharmalliance supports the full cGMP compliance lifecycle with cGMP Compliance and Contamination Control at the heart of everything we do.
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Some of our happy clients
Trusted By Pharmaceutical Companies Globally
Clients include major Pharmaceutical, CDMO and Cosmetic companies, here what they have to say:
Global Aseptic CDMO
Senior Global Director QA
CCS in 6 weeks project
“The whole project was very professionally handled. The experience and knowledge of the Pharmalliance team was outstanding and helped much overcoming misunderstandings and knowledge gaps on our side. Deliverables were provided in time and Pharmalliance kept us on track.”
Sterile Ophthalmic CDMO
QA Remediation Lead
cGMP Remediation Project
“Pharmalliance delivered exactly what we needed – fast, relevant, and high-quality training tailored to our remediation project.
The content was precise and aligned with FDA and EMA expectations for Sterile Manufacturing. Their willingness to adapt the program made a real difference for our team.”
Irish OSD CDMO
Executive Project Lead
Drug Shortage Remediation
“Pharmalliance supplied a team of QA and Engineering specialists who assisted in an operation and quality excellence project.
The result was a marked increase in throughput, which help eliminate a shortage of supply to the market, and a major drop in production downtime.”
Your Compliance Outcomes Depend on The Approach You Decide to Take:
Without a Structured cGMP Compliance Approach
Companies are exposed to increased regulatory, compliance and supply chain risks, where:
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• Inspection findings escalate
• Deviations continue to repeat
• Contamination risks increase
• Regulatory scrutiny intensifies
• Production interruptions occur
Unresolved compliance gaps often remain hidden until regulators identify them.
With a Structured cGMP Compliance Approach
Companies taking a proactive approach to compliance see real benefits, where:
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• Operations stabilise
• Compliance risks are controlled
• Inspections become predictable
• Quality systems strengthen
• Supply reliability improves
Structured remediation restores control and reduces regulatory uncertainty.
Address
Glasshouses G2,92 George's Street LowerDún Laoghaire, Dublin, A96 VR66, Ireland
Phone
+353 (0)1 969 2000
