GMP Compliance Adviser Update No. 4/2017

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

6.J Example SOP for the qualification
of equipment and machinery

Data integrity in the quality control

15.H Data integrity - general requirements
in a GxP-regulated environment

GMP in Practice

Chapter 6 Qualification

6.J Example SOP for the qualification of equipment and machinery

This example for a qualification SOP is applicable for all kinds of equipment up to standard off-the-shelf equipment. With the aid of an assessment matrix these are classified into different risk categories. Depending on the risk category, the qualification requirements differ in type and scope. This chapter also entails a process flowchart for qualification and examples for a qualification checklist and FAT/SAT plans and protocols. (Cornelia Wawretschek)

Chapter 14 Laboratory Controls

14.N Data integrity in the quality control laboratory

Data integrity plays an important role in pharmaceutical quality control because the results that are generated are used to evaluate the quality of the product and are therefore relevant for batch release. Data on sampling and the handling of samples is frequently stored in a LIMS. In practice, however, hybrid systems are also used. When this is the case, special care must be taken to ensure that data is properly transferred. Data on sample preparation and preparation for chromatographic determination is generally documented on paper. Not all of the data must be transferred to the LIMS, however, it is important to ensure that the batch-related traceability of data does not depend on the type of documentation used. During chromatographic determination, only electronic data is generated. It is read in the form of integrated chromatograms and the resulting peak areas. Subsequent manual reintegration is not always avoidable and continues to be a controversial aspect with regard to data integrity. The further processing of data during evaluation can be carried out using integrated evaluation software, LIMS or external programs. Different aspects of data integrity need to be observed. This is a common source of noncompliance that is often not recognised by the operator and/ or cannot be influenced by him/her and also explains why the authorities stipulate that an audit trail review has to be carried out prior to batch release. When a report is generated, it must be ensured that it is an original document, regardless of whether it is paperbased or electronic. The storage and archiving of data must also be regulated in detail so that the data is protected against subsequent manipulation, unauthorized access or loss. It must also be ensured that the data can be retrieved and remains legible for the entire mandatory period of retention. (Prof. Dr. Markus Veit)

Chapter 15 Documentation

15.H Data integrity – general requirements in a GxP-regulated environment

Data integrity is a key element in the pharmaceutical quality assurance system. It is not a recent requirement, but is already anchored in the principles of the EU GMP Guidelines. However, the topic has become more important in recent years, especially from the viewpoint of the authorities. This is the result of the ever-increasing flood of data, particularly electronic data. The significance of data integrity is reflected in the current WHO, MHRA, EMA and FDA specifications. The ALCOA principle summarises the most important requirements for data integrity: data must be attributable, legible, contemporaneous, original and accurate. To comply with the requirements of data integrity, suitable monitoring systems must be in place. In addition, regular personnel training on the importance of data integrity must be carried out. The demand for data integrity applies to the entire life cycle of the data. The prescribed mandatory retention periods must also be observed. (Prof. Dr. Markus Veit)