Department of Pharmaceutical Quality System

At Mahestan darou pharmaceutical company, our quality system consultants have extensive experience in any steps of pharmaceutical quality management system (QMS). Our quality system consultants’ help the clients to ensure their products are consistently manufactured at a good operation practice. 

We are able to establish and implement an integrated quality system (PQS, QA, QC and GMP) in pharmaceutical and Nutraceutical Company based on latest regulatory from MOH or any other regulatory bodies such as PIC/S.

We believed that the pharmaceutical quality system (PQS) should be well- defined and implemented in all levels of pharmaceutical industries. PQS is responsible to ensure all processes are deployed in an appropriate manner. This quality system needs some elements which are:

    1. Quality policy, quality manual and well established document system

    2. Process performance and product quality monitoring system

    3. Corrective action and preventive action (CAPA) system

    4. Change management system (QRM)

    5. Management review of process performance and product qualit

We believed that implementation of PQS ICH-Q10 in pharmaceutical industries should facilitate Innovation and continual improvement throughout the product lifecycle.

Some of our capabilities are:

    1. Development, assessment & optimization quality management system

    2. Development, assessment & optimization quality assurance (QA) system

    3. Development, assessment & optimization quality control (QC) system

   4. Preparation & optimization of documentation system (SOP, check lists, batch Record, labels, logbooks, site master file: SMF, quality manual, quality risk management: QRM, out of specification:     OOS, post marketing quality control: PMQC, and ,,,)

    5. Planning & execution Corrective & Preventive Action (CAPA)

    6. Training on different aspects of quality system including, Good manufacturing practice (GMP), Good laboratory practice (GLP), Good storage practice (GSP), and totally GXP.

    7. Planning and implementing internal and external inspection.

    8. Planning and implementing validation process including (Validation master plan: VMP, Cleaning validation, Qualification)

Our regulatory consultant are well proficient and acquainted with all regulatory instructions and guidance. They prepare and optimize common technical documents (CTD) for the registration of pharmaceutical products in MOH.