GXP consultation

We offer our services in preparing the facilities and utilities of our clients for GXP   ISO 9001:200  8  , and ISO 14001:2004 requirements that aim to: improving the company, increasing its profitability and saving its time, effort and money through issuing conceptual designs such as rooms’ required spaces to meet GXP requirement, material and personal flow layouts in addition to the required utilities’ specifications for GXP and Room Data Sheets

The consultation service includes:

1.     Reviewing of available layouts, specifications, material flow, and personnel flow, Electromechanical layouts…etc.

2.     Assessment and Gap analysis for the compliance to ISO/GXP requirements,

3.     Site Inspection and recommendation of Corrective/Preventive actions

4.     Conducting statistical and optimization studies for operational procedures to define the best practices of each department process on total process and recommend process improvement actions, company profitability increase, and time/efforts loss decrease.

5.     Build up the basic documents for the compliance of GXP, ISO9001:2008 and ISO14001:2004 that will efficiently increase the profitability of work performed.

6.     Provides Quality Assurance Activities Management software (QAMS) that complies with GXP, ISO standards. The QAMS software shall be provided as validated software based on Good Documentation practices and according to GXP guidelines

QAMS Software shall contains (as requested) the following modules:

  • Documentation module:
  • Training module:
  •  Analysis module:
  •  Change Control module
  •  Customer Complaints handling module
  • Out-of-Specification handling module
  • QAMS Software is supported with Arabic and English languages
  • Auditing of raw material and packaging material suppliers in and outside Jordan for several companies that decrease the cost of this matter on each company