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Pharmaceutical Manufacturing and Packing Sourcer

Facilitating the Audit Process

External auditing of suppliers is a time-consuming exercise, but there are ways to ease the process. External audits are an expensive business, both for the auditing company and the supplier or contractor under scrutiny. The time involved in preparation, the audit itself, subsequent questions and clarifications and - for the auditing company - the writing up of the report, is not inconsiderable.

Even for a small facility, the hours involved for the total process can tie up the personnel involved for more than three days, and for larger sites it could be considerably longer. Multiply this by the number of suppliers a typical pharmaceutical house has - plus the number of internal audits carried out - and it comes as no surprise that large pharmaceutical houses have teams of dedicated auditors and even small concerns will have some staff seriously distracted from their 'real jobs' by the auditing process.

Of course, these personnel are carrying out a vital role in ensuring that those supplying goods and services to the company are of a certain standard. Their role in maintaining internal procedures will also reflect positively on the quality of their end products.


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By Mike Parker, QA and Technical Director, Brecon Pharmaceuticals Ltd Mike Parker is Quality Assurance and Technical Director of Brecon Pharmaceuticals Ltd, specialists in clinical trial supplies and packaging and distribution services for the pharmaceutical industry.Mike studied chemistry at Strathclyde University and graduated in advanced analytical techniques. He started his career as an Analytical Chemist working in R&D and now has 30 years' experience in both large and small pharmaceutical companies, including Laporte. His 10 years of production experience includes responsibility at board level for three production factories. He is also one of the three qualified persons employed at Brecon. Mike Parker is Quality Assurance and Technical Director of Brecon Pharmaceuticals Ltd, specialists in clinical trial supplies and packaging and distribution services for the pharmaceutical industry.
Mike studied chemistry at Strathclyde University and graduated in advanced analytical techniques. He started his career as an Analytical Chemist working in R&D and now has 30 years' experience in both large and small pharmaceutical companies, including Laporte. His 10 years of production experience includes responsibility at board level for three production factories. He is also one of the three qualified persons employed at Brecon.

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