Pharmaceutical and Biotechnology Markets

Overview

MAAK Technologies Group Inc. has extensive experience regarding the regulatory requirements to which pharmaceutical and biologics manufacturers must adhere. Automation systems are designed to ensure the customer production facilities meet cGMP requirements. SCADA and data management systems are designed to achieve 21 CFR Part 11 compliance. Additionally, we recognize the importance of adhering to the customer’s Standard Operating Procedures (SOPs) and Change Control procedures.

MAAK has supplied many validated automation systems to the pharmaceutical and biotechnology industries. These automation and control systems include bioreactors (mammalian and bacterial), ultra-filtration, media preparation, CIP, autoclaves, chromatography, WFI, and HVAC.



Documentation and Validation

Validation considerations are crucial to the supply of control and SCADA, batch and data management systems. These systems are specified and designed to ensure 21 CFR Part 11 compliance.

MAAK follows a Quality Management System which encompasses the Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The formal management model is based on the life-cycle concept for the development of automated systems. The life-cycle concept covers the phases of planning, specification, design, construction, testing and system acceptance, and ongoing operation.

  • Detailed Design Specification (DDS)
  • Structured, Modular and Fully Documented Software
  • Software Life Cycle Management
  • System Hardware and Software Test Plans
  • Software Bench Testing
  • Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ))

    • This documentation assures the customer and regulatory authorities that the Control/Automation System has achieved the required operational specifications as intended.