Good Manufacturing Practices Compliance

Current Good Manufacturing Practices (cGMP) are key to any successful manufacturing facility across the healthcare industry. However, clients often fail to realize that adherence to cGMPs prescribed by various Health Authorities (HAs) has its own advantages. That’s why we ensure that our approach to cGMP compliance is holistic and comprehensive.

Our solutions in the cGMP compliance space includes planning Greenfield Projects from scratch. Our Quality Assurance Experts have experience in navigating highly regulated markets to assess compliance, with cGMP standards which include US, EU, PIC/S, TGA, WHO, and globally, with other country specific cGMP standards too.

We also provide Quality Management System audits for medical devices to obtain CE markings for Europe, Establishment Registrations with the US-FDA as well as for the ISO 13485 certification.

BUILD

Greenfield Projects

Our expertise allows us to integrate cGMP compliance at the conception stage of a Greenfield Project Facility. We have the patience and experience to handhold you right from building plans stage, up until you are awarded the desired cGMP compliance certification .

We save our clients valuable time and resources which are key to product launches and facility expansions, to promptly service growing demands.

 

  • Facility Layout Designing
  • Reviewing building plans
  • Dedicated project managers
  • Preparing Site Master Files, Master Plans, SOPs and all related technical documentation
  • Equipment Installations, Validations and Upgradation
  • Utility Systems Evaluation, Validations and Compliance
  • Quality Control and Quality Assurance System Compliance
  • Manufacturing, Storage and Supply Compliance
  • Personnel Training

Operate

GMP Strategizing

Behind any successful facility and especially export oriented production units, are the right cGMP certifications. We help you effectively strategize your cGMP certifications by identifying the right overseas markets for your current production facilities.

We help you recognize and choose the best value for your growing business through customized and efficient cGMP compliance solutions and strategies.

  • Detailed advisory for GMP certification options with thorough cost-benefit analysis
  • Customized strategies, action plan preparation and execution
  • End to end GMP certification solutions

ANALYZE & BRIDGE

Gap Analysis

Our informed, efficient and instantly deployable team, ensures that we can premeditate gaps in your facility’s cGMP compliance, before a regulator. We also specialize in providing advice and services to bridge these gaps, so that your facility remains inspection ready, at all times.

 Our clients trust us with being extremely thorough, so as to deliver maximum value at affordable prices and within stipulated timelines.

  • Detailed regulatory gap analysis
  • Action plan preparation and execution
  • Preparing Site Master Files, Master Plans, SOPs and Technical Documents
  • Facility and Vendor GMP audits
  • Equipment validations and upgradation
  • Utility systems evaluation, validations and compliance
  • Quality Control and Quality Assurance System compliance
  • Manufacturing, Storage and Supply Compliance
  • Personnel training
  • Inspection readiness
  • Computer system validation
  • Data Integrity

Get a quote for a cGMP compliance Audit today!