Masterarbeit

The Role of Microbiological Test Methods in Enhancing the Availability and Ensuring the Safety of Pharmaceuticals for Human Use

Girmay Gebremedhin (2011)

Language: English

For emerging pharmaceutical companies, selecting suitable microbiological service providers, that meet pharmacopoeial regulatory requirements is a challenging task.
In this piece of work we have studied and analyzed existing documents which can help pharmaceutical companies make sound decisions in selecting contract research microbiology laboratory (CRML). Some of the documents we look into include 21 CFR 211 of FDA (cGMP), ISO 17025 (accreditation of laboratories) and Pharmaceutical inspection convention/cooperation scheme(PICS). We have also utilised other tools of decision making in selecting an appropriate CRML. Other existing pharmacopoeial chapters relevant for CRML activities and microbial quality testing of pharmaceutical and medical devices products were thoroughly considered. These include microbial limit test methods of non-pharmaceutical and pharmaceutical products as well as different tests such as those used in sterility, endotoxin and efficacy of preservatives. Furthermore to ensure that the CRML activities were correctly done, we analysed quality management in microbiological laboratory settings.

In our analysis of the regulatory documents, we found that specific qualities have to be met by the CRML before it is selected by a potential customer. For example we found that the chapter 21 CFR 211 of FDA (cGMP) demands that any CRML should work in compliance with GMP guidelines. Similarly ISO 17025 investigates the availability of proven evidences of managerial and technical competence of the CRML that will be needed to carry out microbial quality tests and PICS which can be reviewed as a checklist of quality to be met by CRML during inspections by potential client. The decision making analysis showed how to select the best CRML whenever more than one options exist. The pharmacopoeial chapters we investigated showed the main tasks of a contract research microbiology laboratory (CRML) during microbial quality testing of pharmaceutical and medical devices products. In other words, the review shows the ability of CRML to carry out complex analysis of quality control of pharmaceutical and medical devices products required by regulatory agencies for marketing authorisation. Finally we found out that quality management, quality assurance, quality control and standard operating procedures (SOPs) as necessary backbones for a responsible CRML activities.

This work has showed how important microbial testing is for pharmaceutical product during its marketing authorisation. Thus a reliable microbiology laboratory may serve as a bridge between drug manufacturers and regulatory agencies in enhancing regulatory processes.

Pages : 60