In any industrial activity, work instructions are the basic and reference documents for operators, but also for the teams in charge of controls. The same is true in the pharmaceutical industry, a sector where the quality of products – in this case medicines – is even more sensitive and for which no breaches are accepted. The importance of having instructions to ensure the efficient conduct of manufacturing is therefore all the more important.
To better understand the issues associated with this type of document in the pharmaceutical industry, it seems appropriate to focus on the following points:
- The functions of instructions in the pharmaceutical field
- The types of data to be provided by the work instructions
- The characteristics that must be found in it if they are to play their full role
- The need to switch to digital work instructions
What is the role of work instructions in the pharmaceutical industry?
In the pharmaceutical industry, work instructions are used to produce and manufacture drugs. These documents have three main roles.
First of all, these supports are there to ensure the understanding of the actions to be taken by operators, and thus to guarantee the compliance of operations and their results with the requirements.
Whatever the formats used, they provide all the data necessary to ensure that the instructions and formulas are applied without risk of error, misinterpretation or omission. These work instructions must, therefore, ensure compliance with GMP (Good Manufacturing Practices), which are qualified as “quality assurance” and applied by all pharmaceutical industries worldwide.
The second role of work instructions is to facilitate tracking and tracing to support continuous improvement. In this field, they complement the registrations, or reports, which are of twofold importance: checking the compliance of actions with the instructions and having a history of the medicinal products produced throughout the manufacturing chain.
The third and final function of work instructions in the pharmaceutical industry derives from the first two: to guarantee the quality of the product.
It is, in fact, the proper application of operating procedures and their monitoring that ensure that medicines ready for distribution comply with the requirements, standards and expectations of both buyers and supervisory and regulatory bodies (health and medical authorities, etc.).
What exactly do they specify?
The work instructions used in the pharmaceutical industry include different types of information, ranging from specifications to procedures.
It, therefore, includes compliance requirements for products (specifications), raw materials, processing and handling tools and processes (packaging, control, etc.), as well as standardized procedures.
To these are added, for the implementation of very specific operations and the keeping of reports on them, what are called protocols. Finally, the instructions also include specifications when operations are outsourced to external service providers.
How to create work instructions, then? In principle, therefore, it is sufficient for the operator to have the work instructions in front of him and to apply them to the letter so that the operations are properly carried out and the medicines are in full compliance.
What qualities should they have?
To perform all its functions, work instructions for the manufacture of medicinal products must have a number of qualities:
- Precision: the information contained in it must be accurate, error-free and written (or illustrated, schematized… depending on the format) without leaving room for interpretation.
- Brevity: content should not be overloaded with unnecessary or irrelevant data. Only those related to the tasks to be performed should be present.
- Readability: the data must be perfectly organized, presented in a language that is totally understandable and adapted to the user.
In short, quality work instructions are essential in the pharmaceutical industry, where products of a particular type, such as drugs, must be manufactured. We are in a field, health, where we must be absolutely irreproachable at all levels.
Digitize work instructions, why?
The advantage of using dedicated solutions to create digital work instructions is the transformation of these static documents into dynamic documents. The work instructions are now intelligent and become a real work tool for operators:
- Help them to do their job better by removing any ambiguities
- Simplify and facilitate field data collection
Traceability is also supported
Picomto is the digital work instruction solution dedicated to the pharmaceutical industry and GMP / BPF regulation. Feel free to contact one of our experts to find out more about how we support you.