Pharmaceutical Quality Management Services: (QMS) – Enpee Pharma TPA

Pharmaceutical Quality Management Services: (QMS)

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(QMS)

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