Say what you do and do what you say

Laporte Fine Organics, based in Middlesborough, manufactures speciality, organic, pharmaceutical and agrochemical intermediates. But just getting these products to market requires serious scrutiny.

The company has Type 1 and 2 drug master files registered with the US Food and Drugs Administration (FDA), is ISO9002 (BS 5750 pt 2) accredited, and adheres to GMP (Good Manufacturing Practice) principles. However, these are only the outward signs of the control needed to provide quality to customers.

Quality is `built-in' to the plant, the management systems and, through training, to everyone on site, claims the company.

`We tend to work to the higher standard which is generally GMP for the FDA,' says Ian Munro, quality control manager at the Seal Sands site. `It is almost impossible to operate a lab with multiple standards. You just get ghastly mistakes being made all over the place. We apply GMP principles in the laboratory across the board,'

`GMP principles are basically "say what you do and do what you say." Everything is auditable. All our methods are typed and authorised. In many cases we've done collaborative studies with the client to determine any differences between us doing the analysis and them doing the analysis. If a batch fails we apply GMP principles. But even if you record a failing, it hasn't automatically failed until it's been investigated.'

Chemicals at Fine Organics are produced under two regimes:

(1) Contract/Toll manufacture.

(2) Production of versatile, high value, multi-user intermediates.

Most of the reactions on the site revolve around an ability to control energetic reactions, often involving handling of toxic, dermatitic, flammable or malodourous compounds.

`The problems we face vary widely,' says Munro. `There are method problems because we do toll manufacture. So we don't actually create our own methods. We are given a methodology by the customer to do the analysis. And often that methodology isn't particularly robust. Customers make a request of what they want - a specification - which is a list of parameters relating to identity and chemical purity.'

The range of products required by customers demands flexibility within the plant. Much of the equipment installed at Fine Organics has been selected to provide the versatility and ease of configuration for rapid, low-cost response to customer needs. This however, causes problems when changing from one product to the next, explains Eddie Shakespeare, quality assurance manager at the site. Any trace of the previous batch can affect the new product stream. Equipment is required to detect impurity down to ppm levels.

Sophisticated analytical equipment is continually upgraded to match the developing needs of customers and includes gas-liquid chromatography, HPLC, GC/Mass Spectrometer, and IR/UV analysis.

`The quality control lab we have here is mainly a chromatography lab and we use liquid and gas chromatography and a little of classical analysis such as titrations,' says Munro. `It's a very busy lab. We have up to 500 batches a month coming through.'

The research and process development staff are supported by 26 analytical chemists involved in all aspects of quality control including raw material validation, in-process QC, finished product analysis and environmental monitoring.

`On a day to day basis there are the usual problems of conflict between production if they are running the batches on a marginal basis. If they are producing something which is very close to specification you then have a very strong statistical chance of failing the batch. And that can produce varying levels of aggression between internal departments!' PE