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AmazonPharma

GMP Services

AmazonPharma consultants enhance Good Manufacturing Practice standards within the production environment as well as ensuring compliance to the regulatory bodies. Our consultants are outstanding hands-on leaders who motivate, train and provide guidance to your teams to ensure consistent results well beyond expectations. We will not only assist you in interpreting the various regulatory standards or provide you with technical advice but we will coach and mentor your staff to constantly achieve well above planned target.


Let's turn challenges into opportunities that can expand your business and result in sustainable growth.

AmazonPharma

AmazonPharma will ensure that you manufacture safe products, while committed to assist you to achieve business goals and maximise return on investment. Whether you are looking for a complete package or you need urgent solution for specific task, our experienced consultants can assist you. We are time conscious and we will respond quickly. Our services include Compliance to Regulations, Personnel Management, Development & Coaching, Cultural Change and Pharmaceutical Lean Manufacturing. We will Audit your Australian and  Asia Pacific manufacturing facilities and suppliers for compliance to cGMP.

GMP SERVICES

 

 

Quality Services

  • Mock Audit
  • Facility preparation for Audit
  • Assistance during and post Audit
  • Assistance in closing out deficiencies and non-conformances observed by Regulators
  • Internal, External  and 3rd Party audits
  • Compliance Gap Analysis
  • Quality Agreements
  • Annual Product Review

Consultation based on the following standards: TGA, PIC/S ,WHO, FDA, EU/EMEA

 

Quality System

  • Quality Policies
  • Deviation
  • Out of Specification Investigation
  • CAPA
  • Change Control
  • Contractor Management

 

Documentation System
  • Site Master File
  • Quality Policy Documents
  • Quality Agreement
  • Validation Master Plan
  • Validation Documents
  • Standard Operating Procedure
  • Operation Manuals
  • Manufacturing Batch Record

 

Training
  • GMP Training – induction and ongoing
  • Development of Training Programs
  • Development of Assessment Tools and competency based testing
  • Group Training Sessions targeted at various levels (Production, Maintenance, Warehouse, Supervisors and Managers)

 

Pharmaceutical Lean Manufacturing
  • Lean Manufacturing & Continuous improvement - Review manufacturing process flows and product streams to ensure only "value adding" activities are included. Eliminate waste and reduce variation within process to ensure compliant and safe products are manufactured at most competitive rate. 

 

Human Error and Pharmaceutical Industry
  • Behavioural GMP -Human Error analysis. Employee change behaviour programs to meet business strategies and compliance targets.

 

Industry Links

 

 
Please contact us to find out how we can help you!

 

 

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GMP Services ArticleOverview of supplying therapeutic goods in Au

Therapeutic goods can be very beneficial, but to be effective they must modify the way the body works. This means there are risks, as well as benefits, associated with their use. Because of these risks, these products must be regulated in order to protect public health. Therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in or exported from Australia, unless exempt from being entered in the ARTG, or otherwise authorised by the TGA.

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Quality Risk Management

Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

The quality risk management system should ensure that: -the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient; -the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.

 

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