Azimuth - Quality

• Which Qualification strategy is the right one for your company?

  • A Traditional Qualification Approach, a leveraging / ASTM E2500 Approach or a hybrid one?

• What can be leveraged and what typical stumbles do you need to watch out for?

• Which documents do you need with the different concepts to be compliant?

• How to design the content of the documents not to create gaps?

• How to release the facility from the Commissioning to the Qualification phase, to the Validation phase and finally for GMP Use?

• Where do you need to execute revalidations and where is a periodic Review sufficient?

• What is the content of a pharmaceutical Quality Management System?

• Have you ever wondered how your core business and your department structures feedback to your QMS Design?

• What do you have to have in place and by when, when building a new facility or starting a project?

• Which concepts can be combined to create a lean and easily manageable effort to maintain?

• How do I design my maintenance and calibration program?

• In which part of a project does my maintenance and calibration program need to be finalized? 

• What role does the initial Qualification play in the setup of my concept?

• What spare parts do I want to keep in stock and what can be ordered when needed?

• What role does QA play in the maintenance and calibration program?

• Should you combine your CSV with your equipment qualification testing or rather do it as a standalone concept?

• What do you need to test and what part has the vendor already covered?

• What can be leveraged and when?

• How is a CSV concept for Equipment different from a concept for an Application?

• How to ensure data integrity today and demonstrate compliance with 21 CFR Part 11 and Annex 11?

• What does lean CSV mean and how is it applied?

• How to approach the validation of cloud solutions?

• How many room PQ’s do I need to execute and how do I set the scope and acceptance criteria in respect to physical parameters, non-viable particles, viable particles/active air sampling, viable particles/passive air sampling and surface sampling?

• When do I need growth promotion testing?

• When does my Disinfectant Efficiency study need to be done in respect to the Room Qualification?

• How do you define alert limits and action limits and how do you do the trending of your results?

• How to develop a CIP cycle?

• How to choose your cleaning and sanitization agents?  

• What role is my Riboflavin testing playing in the Cleaning Validation?

• What to test for in a cleaning validation and what kind of sampling methods do you need?

• How do I qualify my samplers?

• How do you incorporate your recovery studies in the calculation of your cleaning validation?

• How do I pick my sampling surfaces and location on a risk based approach?

• How to implement the Annex 1 Requirements for your Contamination Control Strategy?

• Do you face challenges with containing your high potency product?

• How can you mitigate identified risks by additional studies, monitoring, physical measures or concepts?

• Are the process controls you currently have in place sufficient?

• Which Strategy is the right one for your company and accepted by the authorities for your product, Concurrent Validation, Traditional Validation, Continues or Hybrid?

• What parameters do I test in my PPQ with the different approaches, and to which extent? 

• What do I monitor in my Ongoing Process Verification and what do I cover in my Annual Product Quality Review?

• How will it go hand in hand with my Contamination Control Strategy?

• Do you need a mock inspection to prepare for a customer or authority audit?

• Do you need a Subject Matter Expert to help you cover a specific topic in an audit?

• Do you need a SME to help answer Audit Findings and to put the Corrective and Preventive Actions in place?

We, as Azimuth Quality have a broad network of subject matter experts from various specialty fields. If your need cannot be met by us alone, we are happy to help advise you on finding the right experts, which we have worked with in the past, to get the job done.