Careful management of specifications makes pharmaceutical products safe - Part 2

The "Careful handling of specifications in pharmaceutical quality systems“ theme is dealt with as a four part BLOG article. The article describes which cardinal errors occur when dealing with specifications, salient incorrect assumptions regarding them and how errors in managing specifications can be avoided.

Maintain traceability for specification changes in GMP

Because justification of specifications is required, but also of expected changes in the specifications in the life cycle of pharmaceutical products, it is important to ensure traceability for additions and changes to specifications. This can only be done through appropriate documentation and a change control procedure for such changes. At the same time, a degree of uniformity in specifications must be ensured at certain times in the life cycle of a pharmaceutical product so that decisions and processes, such as the implementation of further phases of the life cycle, can be made on the basis of these results.

In the course of development there may be different specification lists for the same development product, due to a thematic breakdown or a chronological sequence of development phases. Different specifications for the same product, e.g. from the laboratory and a technical center, often lead to lengthy discussions about which of the specifications is the right one.

This problem can be counteracted by clearly defining the function or application of the specification and creating summary specification lists at certain points in the product life cycle.

Here is an example: No later than the end of product development, a summary list or "specification" for the development product should also be available in order to draft a summary development report. The list is provided with references to the respective tests or development studies, which include the reasons for determining the specifications. This procedure ensures that there is adequate traceability for the selection and determination of specifications. At the same time, such a list is a prerequisite for transferring the development process to production.

Specifications used or determined in the course of development are thus, even if it is sometimes seen differently, not a relic or waste that is no longer needed in later phases of the product's life cycle. Rather, they are essential results and control elements, together with their changes, and can become particularly relevant if subsequent problems arise during production. They help to understand why the product and its manufacturing process were developed in this manner. This makes them an integral part of official inspections, especially if they are initial inspections (e.g. a pre-approval inspection).

However, for reasons of patient safety and product improvement as part of its knowledge management, the manufacturer should also be interested in achieving traceability of the specifications regarding product and process development and the life cycle of the pharmaceutical product Last but not least, proper management of specifications avoids repetition of errors and discussions through to the repetition of entire development studies and process validations (see below).

In summary, the development specifications form an essential part of the basic knowledge of the product and the manufacturing process. They are therefore a valuable treasure trove of expertise that is necessary for patient safety and product improvement and can be used specifically for this purpose.


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