GMP Compliance Consulting
We provide regulatory services in handling CAPA management post GMP inspection by regulatory authority. Improvement on existing CAPA, Deviation, Change control and Investigation systems, QRM, Complaint and Recall Handling, GAP Analysis, Contract Services Management and GMP Documentations.
GMP Compliance Portfolio
Pharmaceutical
Penang, June 2018 – Oct 2019
Scope of Service
Pharmaceutical Quality System improvement covering QA, Eng, Prod, QC and Warehouse
Dosage Form
OSD
Galenicals
Pharmaceutical
WHO, Oct 2019
Scope of Service
WHO Technical Assistant from Regulatory System Strengthening (RSS), Department of Essential Medicines and Health Product, Health System and Innovation, WHO in providing expert opinion in development of CAPA for the manufacturing facility, review of quality system, review of facility re-design plans and documentations
Dosage Form
Sterile
OSD
Galenicals
TMHS
India, Nov 2018
Scope of Service
Technical review on Indian GMP Schedule M1 Guide against Malaysian TMHS GMP Guide and the current compliance level of a manufacturing facility
Dosage Form
OSD
Pharmaceutical
Pakistan, June 2019 – Mar 2020
Scope of Service
Site preparation for GMP inspection by NPRA for GMP certification according to PIC/S GMP Guide
Dosage Form
OSD, Liquid
Pharmaceutical
Penang, Nov 2019 – Nov 2021
Scope of Service
Pharmaceutical Quality System improvement covering QA, Eng, Prod, QC and Warehouse
Dosage Form
OSD, Liquid
Internal
Pharmaceutical
Penang, Jun 2018 – Oct 2019
Scope of Service
Pharmaceutical Quality System improvement covering QA, Eng, Prod, QC and Warehouse
Dosage Form
OSD
Galenicals
Pharmaceutical
Penang, Jul 2018 – Nov 2019
Scope of Service
Pharmaceutical Quality System improvement covering QA, Eng, Prod, QC and Warehouse
Dosage Form
OSD
Galenicals
Pharmaceutical
Johor, Oct 2018 – Oct 2021
Scope of Service
Pharmaceutical Quality System improvement covering QA, Eng, Prod, QC and Warehouse
Dosage Form
OSD
Galenicals
Pharmaceutical
Kedah, Jul 2018 – Current
Scope of Service
Pharmaceutical Quality System improvement covering QA, Eng, Prod, QC and Warehouse
Dosage Form
Injectable
OSD
Galenicals
Pharmaceutical
Penang, Jun 2018 – Nov 2018
Scope of Service
Periodic CAPA closure review and its effectiveness based on NPRA inspection
Dosage Form
OSD
Galenicals
Pharmaceutical
Dhaka Bangladesh, Jan 2020
Scope of Service
GAP Analysis for Site preparation for GMP inspection by NPRA for GMP certification according to PIC/S GMP Guide
Dosage Form
OSD, Liquid
Internal
Pharmaceutical
Lahore Pakistan, Nov 2019
Scope of Service
GAP Analysis for Site preparation for GMP inspection by NPRA for GMP certification according to PIC/S GMP Guide
Dosage Form
OSD
Pharmaceutical
Lahore Pakistan, Mar 2020 - Ongoing
Scope of Service
GAP Analysis for Site preparation for GMP inspection by NPRA for GMP certification according to PIC/S GMP Guide
Dosage Form
OSD
Pharmaceutical
Johor, Aug 2018
Scope of Service
GAP Analysis and implementation of the differences in July revision PICS GMP Guide
Dosage Form
OSD
Galenicals
Pharmaceutical OTC
Negeri Sembilan, Oct 2018 - Apr 2019
Scope of Service
Full refurbishment of existing OSD manufacturing plant from design, project management, qualification until GMP inspection by NPRA
Dosage Form
OSD
Galenicals
Veterinary
Penang, Jan 2019 - Jun 2019
Scope of Service
Attainment of GMP status for an existing veterinary pharmaceutical manufacturing plant after long shut down
Dosage Form
OSD
Liquid
External