Any action related to medicinal products must be traceable, because the life and health of humans and animals are at stake.
The requirements that have to be fulfilled, in particular the multitude of regulations and meticulous documentation of all actual values and observations, are very different from the practices in other industries. Even though instructions are often read on screen and many records are entered directly into a computer system, an ironic interpretation of the acronym GMP still works: a Great Mass of Paper.
Whether on paper or in electronic documents, careful handling is a prerequisite when dealing with large volumes of data. It is vital that documents or different versions of documents are not mistakenly or intentionally mixed up and data is not lost (data integrity). This is why a document management system must be in place which ensures that each member of staff can access an up-to-date approved version of a document when necessary. If an electronic system is used, the software must be validated (see chapter 7.C What requirements apply to computerised systems (IT systems)?), i.e. the main functions must be tested in advance to ensure that data or documents cannot be modified or deleted by mistake.
Companies are increasingly phasing out paper documents. Work instructions, specifications, reports and other documents are not only created using a computer system, they are also electronically approved and distributed. Anyone who needs process instructions, SOPs or other documents, must open the document in the computer system and read it directly on screen. Many of these documentation systems facilitate the printing of forms, checklists and work instructions. Staff members should only use these print-outs for the period of time specified (usually 24 or 48 hours) to ensure that older versions are not used by mistake.
Informal memos are not permitted in a GMP environment. This applies to both instructions and records.
All documents must state clearly:
These documents are referred to as controlled documents. They are only distributed to relevant persons and are subject to version control, i.e. they cannot be modified at random by any member of staff.
Particular care should be taken when copying documents: every copy, e.g. of instructions, records or printouts, must be complete and legible to ensure that no information is lost. The creation of uncontrolled copies is not permitted. There is a danger that changes to the original or new versions have already been authorised, and somebody is still working with these uncontrolled copies. Errors are inevitable. Companies that use paper-based documentation must define who is authorised to make copies, how originals and authorised copies are identified (e.g. using numbers, watermarks or special paper), and how older versions are taken out of circulation.
Some data and documents are repeatedly used during a normal working day, e.g. for evaluations and reviews. Other data will supposedly never be used again – until a customer files a complaint or a quality issue is discovered. Every single detail is suddenly important when the frantic search for the cause of an error commences. Even documents that have not been used in a long time are examined. It pays off if everything has been recorded and all of the required documents can be retrieved immediately.
Accurate, complete and comprehensive documentation has many advantages:
• reconstruction of origin and use
• determination of all affected products, batches and dosages
Christine Oechslein, PhD
GMP practice, Bad Säckingen
This text is an excerpt from the Step-by-Step Guide GMP Fundamentals.
What is GMP? Why do we need GMP?
You will find answers to these and many more questions on GMP in this easy-to-read guideline. It gives you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP). Some topics are: