cGMP PHARMACEUTICAL COMPLIANCE AUDITING

Compliance audits are regularly conducted across pharmaceutical companies by regulatory bodies and it is important to abide by the regulations. You wouldn’t want to jeopardize your business in any way, merely because you are unaware of cGMP regulations. Thrius Pharma Expertize auditors possess complete knowledge about domestic and international regulations and they can help to ensure GMP compliance is adhered to and there is no room for uncertainty.

Our auditors can help you to conduct the following audits:

I] Facility Audits

This includes:

Inspection of laboratories, equipment and other facilities.
Reviewing of all mandatory documents.
Assessment of Quality Management Systems, internal SOPs and other cGMP documents.
Reviewing validation of product cleaning, manufacturing equipment and product process.
Evaluation of data integrity.

II] Vendor GMP Audits

This includes:

Performing routine and qualification audits of contract facilities used for manufacturing, packaging, labeling and distribution.
Performing routine and qualification audits of suppliers of APIs, raw materials and packaging components.
Inspection of facilities, machinery and equipment.
Assessment of personnel for qualifications and training.
Assessment of cGMP and Quality Systems compliance.
Reviewing organization structure and Standard Operating Procedures.

III] Inspection Readiness and Pre-Approval for Inspection Audits

Our professional audit teams will:

Evaluate if your facility is prepared for regulatory inspections.
Assess whether site personnel is ready for pre-approval inspections by authorities.
Get your personnel ready for inspection interviews.
Assess technical transfer of test and manufacturing methods.

Don’t worry about Good Manufacturing Practices compliance and get in touch with our team today so your business and reputation does not face any issues with the regulatory authorities.