Analytical Solutions to help improve your productivity and compliance to global regulations.

PharmAssure has been founded by directors who have extensive experience in managing a large TGA and FDA approved laboratory. The combined knowledge of our consultants ensures that all analytical areas are covered; from working as a chemist on the bench through to operating a large, busy laboratory, we have the knowledge and expertise to help you. Our consultants can aid you in functions required to run any laboratory (such as validation, calibration, audits), to more specific functions such as how to set up your documentation systems. We understand the whole process involved in the pharmaceutical industry, from formulation through to distribution, and therefore appreciate where an analytical laboratory fits in, and the importance of providing quality data with impeccable documentation. We pride ourselves on never compromising on quality, while always searching for ways of increasing productivity.

The services we offer include (but are not limited to):


 

Our consultants have comprehensive experience managing a large pharmaceutical laboratory that has successfully passed all audits from health authorities across the world (e.g. TGA, FDA). They can advise you on ways to increase your efficiency and decrease your costs while still remaining focussed on quality, the foundation of the pharmaceutical industry. Some areas that we can offer services in or consultation for include (but are not limited to):

  • Laboratory Health and Safety systems
  • Hazardous Substances management, including risk assessments
  • Solvent and Chemical management/segregation
  • Advice on new laboratories, both greenfield sites and incorporation into existing buildings
  • Workflow design, to ensure the most efficient use is made of existing resources
  • Good Laboratory Practice
  • Laboratory documentation systems

 

There is an increasing focus on ensuring all analytical equipment is validated to comply with a range of industry guidelines, including PIC/S, GAMP and 21 CFR Part 11. This can be a daunting task if you are not familiar with the requirements and have little experience in what is acceptable. Our consultants have up to date knowledge of all analytical equipment validation requirements for the pharmaceutical industry. They can advise you on all testing needs and methodologies. Some of the services we can offer are:

  • Design of equipment validation studies
  • Design and preparation of validation protocols
  • Design and preparation of final validation reports
  • Review of IQ/OQ procedures from vendors for compliance with PIC/s, GAMP and 21 CFR Part 11
  • Alternatively, we are able to perform the validation for you and provide you with a complete set of supporting documents upon completion

 

In any laboratory there is a requirement to ensure all equipment used is functioning correctly for its intended purpose, both when new and on an ongoing basis. Our consultants have designed and implemented extensive calibration programs for all equipment used in a typical pharmaceutical laboratory. We can offer you:

  • Advice on which equipment should be calibrated, how often, by who
  • Design of a comprehensive calibration program to suit your needs
  • Management of the calibration program on your behalf

 

Method Validation is an extremely important part of any drug substance or drug product testing program. Through the method validation process, documented evidence is obtained that shows that each method is valid for its intended purpose. Our consultants have experience in all aspects of analytical method validation, and can advise and design studies with you.

  • Design/write method validation protocols
  • Design/write method validation reports

 

We are also able to take the data you have generated and compile a thorough and professional report, ready for submission to any health authority.

 

Process Validation encompasses Manufacturing Validation and Cleaning Validation studies. Few companies have the luxury of having dedicated suites for each product they manufacture, so cleaning validation studies are a must-have of the industry. Manufacturing Validation studies are required for new product submissions as well as on commercial scaleup or when changes are made to existing formulations. We can:

  • Design/write cleaning validation protocols and reports
  • Advise on methodologies for cleaning validation testing, best swabbing method, swab extraction efficiency studies
  • Design/write manufacturing validation protocols and reports

 

Stability studies are required from the initial stages of product development right through to the continuous monitoring of commercial product. We can offer advice on:

  • Stability requirements during product development, through to scale-up
  • Design of stability protocols, in accordance with ICH guidelines
  • Testing requirements throughout the stability program
  • Photostability testing
  • Data presentation

 

Laboratory results and data are a large part of any submission to a health authority. They are the basis for showing the product quality and how this will continue to be monitored once the product has market approval. Our consultants have extensive experience in designing and implementing quality documentation that is clear, concise and accepted across the world. We can offer you:

  • Advice on how to present your data
  • Services whereby we take your data and provide you the final reports/documents ready for submission
  • Advice on exactly what is required for each health authority
  • Testing requirements for both drug substance and drug product, for the global market

 

If you have any analytical issues that you need assistance with, whether it is listed above or not, contact us and we will show you how we can help!