It might sound surprising, but the very extensive body of regulations dealing with pharmaceutical quality control does not provide clear guidelines on how numerical test results are to be determined, reported and/or used for conformity testing. At first glance, the subject appears to be straightforward, but questions soon arise when averaging and rounding are addressed. This chapter explains how reportable results are generated. In addition, the differences are highlighted with regard to reporting in different documents such as certificates, stability and development reports and the product quality review (PQR). The different ways of processing the initial test results (raw data) are examined along with methods for presenting them in a form that is appropriate for reporting and/or for conformity testing. Also included is an interpretation of the current regulatory requirements. (Markus Veit, PhD)
SOPs are work instructions. For this reason, they should be written in a language that is to the point, precise and understandable. The addressee of an SOP is the staff member who requires instructions and/or guidance on how a specific procedure is to be carried out. SOPs are also used to demonstrate internally (e. g. inhouse auditors) and externally (e. g. official inspectors) that processes are carried out in a targeted and specific way. Certain prerequisites must be met to ensure that SOPs can be used in a meaningful and effective way. The SOP must be created, put into effect, trained and understood. A clear structure and uniform format and/or layout of all SOPs improve readability and understanding. SOPs must be regularly monitored throughout their entire life cycle and their content adjusted to suit changed conditions when necessary. An intelligent system of identification facilitates the management of SOPs. SOPs are an integral part of GMP documentation and must be archived. (Christine Oechslein, PhD, Cornelia Wawretschek)
The APIC/CEFIC has updated its “How to do”-Document in the light of recent regulatory requirements. It aims at helping pharmaceutical manufacturers with the implementation of the GMP Guide for APIs and describes current practice.
Take a look at the editorially combined text of “How to do” with Part II of the EU GMP Guide. It provides you with a valuable interpretation tool directly related to the regulatory text.
The following chapters have been revised:
The EMA “Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” gave reason to a lot of questions on how to implement the requirements in the pharmaceutical industry. A draft Q&A-document was then published which caused, however, a lot of discussions. Now, finally, there is a revised version of the Q&A document that covers 13 questions and answers relating to this fervently discussed subject.
We have summarized the most important changes to the draft version for you in our news post of 2nd May 2018.