FREQUENTLY ASKED QUESTIONS

Pharmalliance Consulting Ltd specializes in contamination control, GMP compliance, and quality risk management for regulated life science industries. We support pharmaceutical, biotechnology, and advanced therapy manufacturers in achieving regulatory compliance with EU Annex 1, FDA, EMA, and Health Canada standards.

We support sterile pharmaceutical manufacturing, ATMPs, cell and gene therapy, medical devices, biologics, and compounding pharmacies. Our contamination control strategies are tailored for high-risk GMP environments where sterility, pyrogen control, and regulatory compliance are critical.

Yes, Pharmalliance offers inspection readiness services for FDA, EMA, and Health Canada audits. We prepare your facility through mock audits, document reviews, and training, ensuring compliance with GMP, ICH Q9, and Annex 1 contamination control expectations.

Test your current Quality System maturity and receive an instant readiness score:

Pharmalliance provides expert guidance on implementing EU GMP Annex 1 through gap assessments, CCS creation, environmental monitoring strategies, and personnel training. We ensure your sterile manufacturing operations align with regulatory expectations for contamination control and sterility assurance.

Evaluate your Annex 1 compliance instantly

A Contamination Control Strategy (CCS) is a documented plan that integrates all control measures to prevent microbial, particulate, and endotoxin contamination. Required by EU Annex 1, a robust CCS protects product quality and patient safety in pharmaceutical manufacturing.

Pharmalliance guides you through a structured CCS creation process, including risk assessment (FMEA), facility mapping, microbial control evaluation, and aligning with PDA TR90 and EU Annex 1. Our contamination control experts ensure your CCS is holistic and GMP-compliant.

Annex 1 outlines 16 core elements for a CCS, including facility and equipment design, utilities, personnel training, cleaning and disinfection, environmental monitoring, and quality risk management. Pharmalliance helps integrate all elements into a unified contamination control strategy.

Pharmalliance performs detailed gap assessments comparing your current practices to Annex 1 and PDA TR90 requirements. We identify missing CCS elements, define remediation plans, and support implementation.

Environmental monitoring (EM) provides real-time feedback on contamination control in cleanrooms. Pharmalliance ensures EM programs align with Annex 1, including continuous monitoring in Grade A zones, trend analysis, and actionable microbial limits to support sterility assurance.

Instantly assess your Annex 1 compliance with our Annex 1 Evaluation Tool:

Viable contamination refers to living microorganisms, while non-viable refers to inert particles such as dust or fibers. Both types can affect sterile product integrity. Pharmalliance designs monitoring programs that detect and control both viable and non-viable contamination per GMP and ISO 14644-1 standards.

We review facility layouts, airflow design, material/personnel flows, and cleanroom classifications to minimize contamination risk. Our design input supports CCS goals and ensures compliance with EU GMP and ISO 14644.

EU Annex 1 mandates periodic review and updates of your CCS. Pharmalliance recommends annual reviews, or after any facility, process, or regulatory change. Regular updates ensure continuous improvement and alignment with evolving GMP expectations.

Implementing a holistic CCS per PDA TR90 improves contamination visibility, links QRM with quality systems, enhances decision making, and ensures compliance with Annex 1, improving patient safety and reducing recall risks.

We use Key Performance Indicators (KPIs) such as EM trends, rejected batches, sterility test outcomes, and deviation rates to measure CCS effectiveness. Pharmalliance also supports CCS lifecycle review and continuous improvement.

Yes, our consultants specialize in building QRM programs aligned with ICH Q9 (R1). We help you apply risk tools like FMEA and HACCP to assess microbial, particulate, and cross-contamination risks in sterile manufacturing.

We provide expert root cause analysis and CAPA support for microbial, endotoxin, or particulate contamination events. Our structured approach integrates with your QMS to strengthen your contamination control lifecycle.

Pharmalliance’s CCS and GMP training is available online via our learning platform. It includes 35+ modules, downloadable templates, and expert videos, accessible on-demand for professionals in quality, production, and validation roles.

Yes, Pharmalliance offers both on-site and virtual GMP training sessions tailored to your manufacturing environment. We cover Annex 1 updates, aseptic technique, and contamination control best practices for your facility.

Upon completion of the Pharmalliance CCS training, you receive a Certificate of Proficiency in Contamination Control Strategy, demonstrating GMP compliance capability and knowledge of EU Annex 1, PDA TR90, and ICH Q9 principles.