We can offer facility and product audits to cGMP standards based upon our detailed and hands on experience of both manufacturing and development activities for a range of dosage forms, not just parenteral.
In addition we offer auditing to OECD GLP and GCP requirements worldwide.
For example, audits of parenteral facilities and development plans will consider current requirements such as current EU Annex 1 requirements and, where needed, remedial plans can be issued.
Associates with expertise in validation or pharmaceutical microbiology can be added to the team to suit your requirements.
We can assist in preparation for regulatory agency audits (MHRA, FDA etc). To provide audit preparedness training or even a full mock audit with report if desired. With many years experience of hosting regulatory agency audits we are the perfect partner to assist you during these times.
PJC Pharma’s Consultants can work independently of your QA function or to be integrated as a seamless team as required.
Please contact us to discuss your specific requirements.