On-site audit

A WHO GMP certificate itself is no guarantee for GMP compliance, as it highly depends on how the GMP regulations are interpreted by the national health authorities.

Furthermore, a GMP approval does not cover the manufacturer’s capability to maintain consistency in the used API quality, in-process controls and other routines in the daily production and controls.

In other words, to ensure compliance with WHO GMP guidelines, Missionpharma does not rely solely on documentation. In order to ensure that new as well as existing manufacturers comply with our standards, it is of fundamental importance that our QA team performs on-site audits.

In 2007, our 5 inspectors carried out more than 40 inspections in India, Asia, Europe and Africa.

Inspection guidelines

In order to ensure a harmonized approach, each audit is conducted according to a checklist based on the WHO GMP guidelines and in accordance with written procedures (SOPs).

Furthermore, a detailed inspection report is prepared by our inspection team evaluating the manufacturer for GMP compliance and further documenting the issues raised and the scope of the inspection.

With the relevant product as a starting point, the inspection covers cross-check and verification of data and documentation, such as batch records, stability studies, vendor approval, validation studies, compliance with Standard Operating Procedures (SOPs), the manufacturing process, in-process controls, verification of laboratory raw data and assessment of the manufacturing facilities, ventilation systems, water systems etc.

Inspection results

The conclusions drawn following an inspection are typically:

		Rejection of the manufacturer due to an unacceptable level of GMP compliance or
		Non-prequalifiation of the product or
		Request for implementation of corrective actions or
		Prequalification due to an acceptable level of GMP compliance

The conclusions of the inspection report are always communicated to the manufacturer.

Re-audit

All manufacturers are re-audited periodically, but the performance is continuously monitored as a part of our QC processes. Major changes or observed quality problems may initiate a re-audit any time.

A manufacturer can therefore be rejected based on performance at any time.