We offer many GMP services which can help the clients across globe, ranging from audits to various consulting services. We provide comprehensive, hands-on GMP Quality Compliance services to the pharmaceutical industry ranging from audits to various consulting services.
We frequently perform GMP audits at a number of supplier sites around the world to ensure GMP compliance. We carry out various audits including full Site audits which focus on the facility’s quality management systems and cover a large number of products. The GMP audits are conducted by our qualified and experienced auditors at no charge to the supplier, every 3 years.
With the express permission of the supplier, we add the audit report to our report library. It then can be purchased by our clients. By purchasing our GMP audit reports, our clients only incur a small fraction of the costs usually associated with conducting a supplier audit. Moreover, the customer can receive the report promptly, in time for regulatory inspections.
Our commissioned audits and audit partnership services can minimize the cost of the audit and ensure that our clients receive personalized reports that are dedicated to the areas are most relevant to their operations. With this vast experience, you can rely on us to take complex compliance issues to conclusion.
It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout.
This is GMP compliance audit, often referred to as ‘GMP Mock Audit’ or ‘GMP Gap Analysis’. with many years of experience we are able to provide support in all the following topics.
This is ‘Pre-regulatory Inspection audit’. An audit conducted by someone external to the organization with the purpose of discovering GMP deficiencies and includes following.
The Code of Federal Regulations (21 CFR 820) expects the drug manufacturers to conduct an immediate failure investigation when the product is reported in OOS category. Pharmazone can help in following manner.
In general, GMP monitoring (on-site monitoring of manufacturing process) depends on manufacturing process time period and expectations i.e. only monitoring of critical processes. Following activities shall be monitored at manufacturer site:
With extensive experience of our experts, pharmazone can contribute to Quality consulting and upgradation of any manufacturing sites. We can offer as following: