**11.1. Documentation**

"Which documents do I need?" or "tell me which documents I have to prepare and I will do it" are much heard questions. And this is so because GMP does not provide an answer. An impossible answer, anyway, because documentation is closely related to every particular situation and this is why GMP just mentions the documents directly associated with the products (specifications, formulae, processing instructions, etc.) and some general documents (sampling, testing, release, etc.). Documents have to be established on a case by case base, even if in the end all laboratories finish by having about the same documents and the basic difference relies on their extension and on how information is organized and grouped.

Documentation is used to attain two basic goals, information on how to perform operations, in general, and confidence in the control of critical operations, in particular. The first determines basically the number of documents to be written, whereas the second focuses on their contents.

Write a list of the processes of your company and then prepare flow charts for each of them. By doing this a number of operations will appear. Procedures have to describe these operations. There is no rule of thumb about how many are needed. Neither very long nor very short procedures are practical. Consequently a certain level of grouping is necessary and each company has to decide how to do it. Factors which might help in this decision are basically related to logistics, organization and personnel.

Once you have these flow charts perform on them QRA using a very basic tool such as PHA. This will allow detecting hazards and will oblige thinking of the related control measures. And then, these control measures will have to appear in the documents describing the operations.

Quality Risk Analysis: Value for Money in the Pharmaceutical Industry 407

**Figure 14.** The documentation virtuous circle
