4 of 15

The tracking system
	The tracking system is an integral part of the manufacturing system. The safety of the medicines is extremely important. Therefore, it is essential that any problems that may occur can be traced. This can be done more easily if the medicines are made in batches.

Batch production
	By making the medicines in batches, it is possible to identify exactly when and where a particular sample was made. Also, it is easy to find all the other medicine that was made in the same batch.

Recording the progress of a batch

There are tests carried out at each stage in the production of a batch. These are to check that the medicine is being made correctly and that the manufacturing process is meeting the specification described in the licence. The tests may include:


Physical	Chemical and Biological
testing its compressive strength weighing it measuring the density	testing the purity testing its solubility

The tests are carried out on a batch as it passes through the manufacturing system within the company. The suppliers also check the raw materials for each batch. The results of all these tests are recorded in a detailed register. This ensures that the tests take place and it provides the means of tracing any problems. The system requires staff responsible for a particular stage to:

carry out the tests put a time and date stamp in the register
ensure that the results are within allowed tolerances
attach the register to the batch
sign the register showing that the checks have been made

If there is any problem with that batch at a later date, then the source of the problem can be traced through the register.

Picture 2.2 Wearing safety clothes is important in some areas of the factory.

SAFETY

Many of the processes in the company require specialist safety clothing. Its main purpose is to protect the workers. Often they wear masks to cover their nose and mouth so that they don't inhale the dust from tablets. They may also wear gloves and overalls to cover their skin and clothes. They wear safety glasses and ear defenders in areas where there is heavy or fast moving machinery.

There are also special clothes to keep the manufacturing environment clean and prevent contamination of the product by the operators. They wear nets over hair and beards and put plastic covers over shoes and trainers.

Contents	Close

1. Introduction to the pharmaceutical industry	5. Secondary manufacture
Medicines	Manufacturing tablets
2. Systems in pharmaceutical manufacture	Pressing
The tracking system	Coating
IT, delivery & control systems	6. Packaging
3. The development of a new medicine	The packaging process
4. Primary manufacture	7. What makes pharmaceutical manufacture different?
Chemical technology	7. What makes pharmaceutical manufacture different?
Biotechnology