Quality Assurance & Compliance

Quality Assurance and Compliance

Our consultants have the expertise to perform the following:

• Batch release
• Record and Document Management
• Risk Management via risk assessments, self-inspections / gap analysis.
• Compliance of products by managing the following
  • Stability program and data review
  • Deviation investigations and closures
  • Complaints management
  • Corrective Actions and Preventative Actions (CAPA)
  • Annual Product Quality Reviews
• Vendor Qualifications
• Oversee testing of products for importers (Quality Control)
• Review or write quality agreements

Audits & Remediation

Self-Inspection is a regulatory requirement. Also, before initiating GMP activities with a vendor, it is expected that a vendor assessment includes an audit of the Quality Systems and controls. Our consultants are experienced with the Audit process and can do the following:

• Management of the Self-inspection program
• Customer / Vendor audits, domestic or foreign (3rd Party)
• Provide support prior to, during and after a regulatory audit
• Remediation from critical observations / citations

Training

Staff require the necessary training in the areas in which they are performing GMP activities. The training must typically be done when a new employee is on-boarded or a new or revised Standard Operating Procedure (SOP) is being implemented. It is a requirement for staff to complete training prior to executing the respective procedures.

The training methods used can vary, but typically the training can be done in person with an assessment tool, e.g. quizzes or reading and acknowledging the understanding of a procedure. Quizzes for training on a procedure and a formal written assessment of the individual perform a task from a procedure are typically the best methods. Our Consultants can develop and assist with the GMP training which is an annual requirement. They can also ensure that the training is done efficiently.

Standard Operating Procedures

Generally, SOPs are written by authors who are deemed as experts within their areas of function. Ardent Consultants have the experience and knowledge to provide the following services:

• Perform a gap analysis of your current procedures against the regulatory requirements
• Revise existing SOPs based on Gap Analysis (as required)
• Create new SOP packages
• Maintain the SOPs, electronically and physically and control their distribution
• Prepare the quizzes for each standard operating procedure