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GOOD AUTOMATED MANUFACTURING PRACTICES (GAMP)

GAMP

Ingenuity is the driving force that has reshaped the whole socio economic paradigm. With technology taking the center stage into various sectors, the legacy processes have somehow become redundant. Pharmaceutical industry is one such sector that has seen a huge transformation with various principles and procedures in place to ensure that pharma products have the required quality.

An important set of guidelines that have helped with revolutionizing the overall pharma sectors has been GAMP (Good Automated Manufacturing Practices). It is based on core principles that cover all aspects of production, facility, equipment as well as training and hygiene of staff to ensure quality control into each batch of product. We at A-1 Technology have been at forefront in helping our pharma partners to implement GAMP change control protocols (CCPs) and standard operating procedures (SOPs) that act as an essential piece of the overall framework to cinch the quality of the finished product.

We have been providing necessary documentation and consultancy to our clients in order to utilize automated computer systems validation. We help pharma suppliers to test their manufacturing process as well as supplied system for defects as well as redundancies so as to comply with regulatory assessments.

Why Choose A-1 Technology and GAMP 5:


  • Extensive testing and quality assurance along with cost effective solutions.
  • Our robust quality management solutions are in compliance with international standards.
  • We provide customized bioprocess solutions that can work in correspondence to legacy processes.
  • We incorporate various product verification systems as well as support services for service staff.
  • We ensure final product quality by recaliberating critical manufacturing components through automated systems.
  • Our proven methodology and diverse GAMP expertise results in significant time reduction of equipment qualification.
  • We adhere to regulations and are driven by employee indulgence to ensure continual improvement with commitment to client satisfaction.
  • All the processes and automated systems provided by us are designed in such a way to encompass on a quality culture thereby creating better value for our clients.

Over the years we have supplying extensive project management solutions and manufacturing life cycle services as per the requirements of our clients in accordance to regulations. Our full modular approach as well as predefined set of procedures and processes of GAMP framework has helped our clients to achieve validation and qualification levels to satisfy inspectors.

Our Clients