Regulatory GMP/GDP compliance auditing

The GMPs for the manufacture of Active Pharmaceutical Ingredients (APIs) and Final Drug Products require a full system of Standard Operating Procedures (SOPs), procedures (e.g., receipt, sampling, and deviation investigation), and processes (batch records). We can help you create the systems you need for:

  • Quality Management Systems,
  • Facilities and Equipment Management
  • Laboratory Information Management systems,
  • Materials Receipt, Sampling, and Acceptance
  • Production,
  • Packaging and Labelling and

PharmaConsult Auditing services will;

  • Examine your manufacturing processes and integrity of data collection systems.
  • We'll carry out GMP reviews of manufacturing facilities and quality management systems
  • We'll audit your suppliers and contractors for compliance with GMP, GLP or other standards
  • We'll work with your QPs and other in-house QA experts to improve presentation of facility and systems for Inspectors
  • We'll prepare response documents or appeals on your behalf

The evaluation of the risk to quality will be based on scientific knowledge and ultimately link to the protection of the patient (ICHQ9) and the Quality management systems (ICH Q10)