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 various supplier sites across the globe 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 permission of the supplier, we add the audit report to our report library.
By purchasing our GMP audit reports from library, our clients only spend a small fraction of the costs usually associated with conducting a supplier audit.
Our commissioned audits and audit partnership services can minimize the cost of the audit and ensure that our clients receive personalized reports with areas most relevant to their operations.
With this huge experience, you can rely on us to take complex compliance issues to conclusion.
The process of approving the finished dosage form manufacturer for an API to be used for specific product and includes following.
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.
Before any computer system is used at site, an appropriate level of validation should be in place to demonstrate that the systems are fit for the use and that the computer system produces reliable data.
It is a responsibility of the system owner to ensure that any computer system used during the process complies with the relevant policies/procedures. Following are the Capabilities. Following are the Capabilities.
Conducting CSV audits of the software, infrastructure and IT services at your premises or off-site.
Comprehensive audit with focus on a particular functional area, business operation, or computer system.
Compliance verification with 21 CFR Part 11 and other FDA regulations, Good Automated Manufacturing Practice (GAMP), ICH guidance.
Assessing other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, record retention, and problem reporting.
Our comprehensive CSV services cover one or more of following.
User Requirement Specification
System Validation (Development Life Cycle) activities and documentation
Installation and maintenance
Physical and electronic security
Backup and recovery
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: