Medical Device

Product Design & Development

AS a leading Validation & Compliance Services Provider across Globe ,GAMP Group is dedicated to help pharmaceutical, biotechnology, medical device & Food to navigate the complex project, compliance ,Validation & regulatory landscape.

Our Detailed Knowledge And Understanding Of USFDA, EU GMP, EUMDR, WHO, PICS, TGA, ISPE And ISO Standards Across Multiple Industries Is The Result Of Our Experience As Production/QA Personnel Or As Auditors Working Within Production And Qc/QA Environments.

Validation

Validation is best described as the process of “establishing documented evidence” which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Simply put, it is the act, process, or instance to substantiate something on reliable basis.

Our Validation Portfolio includes :

• GMP Facility Documentation & Validation
• GMP Utilities Documentation & Validation
• GMP Equipment - Systems Documentation & Validation
• Computer System Validation
• Data Integrity Policy, Procedure, Training & Implementation
• IT Infrastructure and Cloud Validation
• CQV -Commissioning, Qualification and Greenfield, Brown Field or Upgradation Project Documentation & Validation
• Thermal Validation System with Kaye AVS Systems
• Smoke Study Projects-Protocol to Review & Report

Our Compliance Portfolio includes :

GMP & GDP Services

• Gap Analysis, Review and Remediation for Facility, Equipment, Utilities and Systems as per EUGMP .EUMDR, USFDA, PICS, WHO,TGA or ISO Regulation.
• Risk & Impact Assessment & Risk Management
• Audit Readiness Inspections & Remediation
• QMS Development, Review and Remediation
• QA, Regulatory & Engineering documentation Review
• Smoke Study Review
• CSV & DI Documentation Review & Audit
• DIRA & Data Governance Programs
• Thermal Equipment Cycle Development
• Quality by Design (QbD) systems & approaches
• HACCP Quality Plans
• Operational Excellence & Process Criticality Analysis
• FMEAs, CAPA Investigations, Investigation Training
• Change Control, Assessment of Change Request (ACR),Deviations and Non-Conformance ,Investigation Reports
• CAPA – root cause investigation and implementation of corrective & preventative actions
• Vendor Quality Agreements review
• Customer Complaints Documentation review
• Stability Reports
• Regulatory Documentation & Inspection
• Staff Training Assessment
• Review of CQ & Validation Documents
• Internal & External audits
• Vendor audit & responses
• Audit Reports including different levels (Critical, Major, Minor, or Observation)
• GMP Training