Pharmexcellearning.com

GMP Lead Auditor

A GMP audit is a comprehensive, third-party inspection of a production company. It is meant to identify operational flaws and legal violations. Along with specific inspection results, GMP audits are meant to communicate a set of standards and guidance on how to meet these standards. To  Provide quality direction in relation to regulatory updates as it impacts on the  GMP audit programme, ensuring continual compliance with policies and procedures.  Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements. To provide the GMP auditing  services  and delivered the more clarity about the loop holes and gap identification , change management , Regulatory compliance requirement and implementation. Customer service deliverable and expectation , value addition in your customer complaint resolution. To support the making of world class manufacturing facility.  DI Practices and CSV requirement. Expectation and implementation of QMS around the site and cluster. To review the ICH requirement and Annex 2,3,4 ,5 . 

Validation Support

Validation Master Planning, URS, Risk Assessments, SOPs, IOQ, PQ, Media Fills, Computer System Validation/21 CFR Part 11. Specializing in qualification planning, protocol generation and execution with deep experience mitigating issues and streamlining this process to improve timelines, cost and ensuring it is done right the first time.

Support Includes:

02

Equipment Facility/Utilities

01

Manufacturing

03

Laboratory Instruments

04

Shipping, Cleaning, Process, Media Fills

05

Cleaning validation

06

Process validation

07

Water system validation

08

Packing validation

Engineering

  • URS, FS, DS, SDS, Commissioning Plan, Engineering Studies, DR/DQ, FATs, SATs, TOPs, Commissioning Protocols and Reports, Cycle Development, Process Characterization,
  • BMS AND HVAC SERVICES / SUPPORT (management services).
  • Process engineering.