GMP Audits (remote and on site)
The manufacturers of drug substances and drug products must operate in accordance with GMP regulations. A way to independently assess GMP compliance, is to perform an audit, which is undoubtedly one of the most important activities undertaken on the way to prove that a given site meets all the necessary GMP requirements.
During such audit, it is checked whether the manufacturing sites (including quality control or warehouse) follow a wide range of GMP rules, which are described in the Pharmaceutical Quality System.
Procedures, Instructions and records described i.e. manufacturing process, quality control, personnel, raw material supervision, outsourced activities, self-inspection, deviations, complaints and product recall, etc. are verified.
What is more, there are separate GMP guides for APIs or medicinal products used in clinical trials.
In the case of a medicinal product manufacturing site the document, which confirms that GMP requirements are implemented is MIA (manufacturing and Import Authorisation) or/and GMP certificate issued by relevant Competent Authorities. For active substance manufacturers (including the intermediate manufacturers) it is the Qualified Person (QP) who issues a so-called QP declaration. It guarantees that the API is manufactured according to GMP.
In order to do that, QP must base their assessment on the results of an audit. Such audit may be performed by QP by itself, or can be outsourced to a third party.
For active substance manufacturers (including the intermediate manufacturers) it is the Qualified Person (QP) who issues a so-called QP declaration. It guarantees that the API is manufactured according to GMP. In order to do that, QP must base their assessment on the results of an audit. Such audit may be performed by QP by itself, or can be outsourced to a third party.
Benefits of cooperation
At SciencePharma we offer both: manufacturing site audit by our QP or assessment of audit documents provided by external auditor with the appropriate qualifications.
In both cases we can submit QP declaration (if the audit outcome is positive).
Our GMP Experts conducted dozens of audits and supported many companies in implementing GMP principles in their manufacturing sites leading to positive outcomes of Agencies’ inspections. Our GMP services include:
- On-site audits
- Remote audits
- Support in preparation to the inspection of an Agency
- Assessment of audit reports
- CAPA support.
The scope of our support is tailored to the individual needs of our Clients. Regardless of whether you need to implement the EU GMP requirements or other (US GMP or WHO GMP) please contact us so we can choose the most suitable solution for you.