Enpee Pharma TPA

Pharmaceutical Quality Management Services: (QMS)

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(QMS)

QMS Service home

Pharmaceutical Quality Management Services: (QMS)

  • QMS Gap analysis, redefining of QMS and implementation as per ICH, CFR, EU GMP, WHO and ISO.
  • QMS SOPs. Packages and its review
  • Validation / Qualification Packages and its review.
  • Risk analysis, identification of Risk and mitigation. Protocols and Report preparation.
  • Failure Investigations and CAPA implementations.
  • Validations and qualifications (All e.g Equipment, Process, cleaning, water systems, utility systems, facility)
  • Computer System validations as per GAMP
  • Transport validation / GDP
  • Designing of Quality agreements with KSM/ Intermediate vendors / contract analytical laboratories / Transporters / CMOs .
  • Hosting and support for regulatory audits like USFDA, EDQM, TGA, PMDA, KFDA, ANVISA

Customer Support

  • For better understanding between you and your customer for handling of any GMP, GMP related documentation, Technical or any complaint related issues.
  • Vendor Development and approvals
  • Customer care and support

Technical Advisor

  • QMS, Product, process, system and Facility

GMP Trainings

  • GMP Trainings
  • Trainings program on GMP culture development
  • Trainings on Data integrity, Attitude and behaviours
  • Trainings on failure reductions and effective CAPA
  • Trainings on hosting and understanding regulatory audits and customer audits
  • Interaction with auditors
  • Trainings on compliances write up
  • Trainings on Process Validation/Cleaning validation
  • HR and motivational trainings
  • Corporate & Industrial trainings