Excerpt from the GMP Series "The Road to a Pharmaceutical Quality System"
At first glance, this content appears to be the same as the requirements in the rest of the chapter and the annexes of the EU GMP Guidelines and therefore redundant. It stipulates, for example, that the analytical methods and critical stages of the manufacturing process have to be validated. It also prescribes that processes for the supervision of outsourced activities must be in place.
Furthermore, it is stated that the sampling process may only be carried out by authorised personnel. It is known that the same requirements are set out in detail in Annex 15 and Chapter 7 or Chapter 6 of the EU GMP Guidelines – together with a number of other requirements that are not explicitly included in Chapter 1 of the Guidelines. Why does Chapter 1 single out particular aspects of GMP?
This question is quickly answered when the points explicitly outlined in Chapter 1 of the EU GMP Guidelines are listed in a chronological sequence that corresponds to the manufacturing process chain of the medicinal product. From this point of view, these aspects clearly illustrate how a pharmaceutical plant uses a functioning PQS to achieve a situation that the ICH Q10 Guideline describes as a state of control, see Figure 1.A-8.
Figure 1.A-8 State of control: system for controlling/monitoring process performance and product quality in accordance with ICH Q10.
|State of control in the PQS|
|ICH Q10, glossary "State of Control": A condition in which the set of controls consistently provides assurance of continued process performance and product quality.|
|ICH Q10, Section 1.5.2, Establish and Maintain a State of Control: To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems.|
The GMP elements mentioned in Chapter 1 of the EU GMP Guidelines accurately reflect this requirement in the ICH Q10 Guideline. Broken down to the individual steps of the manufacture of medicinal products, this implies the following (the sections in parentheses refer to the corresponding sections in Chapter 1 of the EU GMP Guidelines):
In addition, sections 1.8 iv–vi and 1.8 viii, 1.9 iv and 1.9 vi in Chapter 1 of the EU GMP Guidelines contain further general requirements. These relate to necessary records, personnel training and the correct implementation of the specified processes. Processes must also be in place for the management of outsourced activities [1.4 vii].
Without doubt, Chapter 1 of the EU GMP Guidelines contains historically evolved redundancies – within the chapter itself and in relation to other chapters and the Annex of the guidelines. This makes a reading of this chapter a little tedious at times. However, the selected aspects of GMP mentioned in Chapter 1 show in a practical way that the previously described PQS elements are not an end in themselves. Instead, the PQS, as set out in Chapter 1 of the EU GMP Guidelines, is meant to serve a single purpose only. The pharmaceutical quality system should ensure that the quality of the medicinal products meet the requirements defined in the authorisation documents, are safe and effective and as a result guarantee the safety of the patient.
Excerpt from the GMP Compliance Adviser
This e-book helps you bring your drug manufacturing quality systems into compliance.
You’ll discover how to look beyond the multiple silos that so easily develop around individual drugmaking activities. You’ll be ready to implement new problem-solving approaches at every level of your manufacturing operations.
The Road to a Phamaceutical Quality System walks you step by step through the processes and procedures you’ll need to put in place.