Pharmaceutical quality system

ICH Q10. Pharmaceutical Quality System, ICH Harmonised Tripartite Guideline, Current Step 2, 09th May 2007. http //www.fda.gov/downloads /Regulatorylnformation/ Guidances/ucm 128031.pdf. Accessed on 04th September 2012. 

Quality Ten topic headings—Stability, Analytical Validation, Impurities, Pharmacopoeias, Quality of Biotechnological Products, Specifications, GMP, Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality System total of 24 guidelines... 

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. 

Food and Drug Administration. ICH QIO Pharmaceutical Quality System, FDA, Rockvill, MD, 2007. 

ICH Q8(R1) Pharmaceutical Development, Nov. 2008 ICH Q9 Quality Risk Management, Nov. 2005 ICH QIO Pharmaceutical Quality System, June 2008. 

A consensus vision statement was drafted at the July 2003 ICH meeting with regard to the objective of the ICH in harmonizing the efforts of regulatory bodies to establish quahty systems approaches in their operations Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science. ... 

Three consensus guidelines define the core of the ICH s involvement in harmonization of pharmaceutical quality systems—Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems (in addition, each of the guidance documents cites critical areas of overlap with Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances). 

International Conference on Harmonization (ICH) (2005), Q10 Pharmaceutical quality systems, final concept paper, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. 

International Conference on Harmonization (ICH) Q 10—Pharmaceutical Quality System. 

Preparation risk if the actual pharmaceutical quality system cannot guarantee that the preparation will fully meet specifications... 

QRM finds its way into medicines regulations as it is seen as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. A structured and documented management of risks is a requirement in EU GMP as well as in the European Pharmacopoeia (Ph. Eur.). A guideline with a description of QRM elements together with appropriate tools is to be found in ICH Q9, mainly directed at manufacturing. Finally implementation of QRM in the Pharmaceutical Quality System is briefly elaborated. 

EU GMP Chap. 1 on Pharmaceutical Quality System highlights the inter-relation of the basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management and emphasises their fundamental importance to the production and control of medicinal products. 

It is neither always appropriate nor always necessary to use a formal risk assessment using the tools given by ICH Q9. The use of informal risk assessment (using empirical tools and/or internal procedures) can be acceptable, as is illustrated by Sect. 21.3 and by the several forms discussed in Sect. 2.2.3 applied to small-scale preparation. However QRM should be part of the local pharmaceutical quality system (PQS) (see Sect. 35.6.8). 

Small scale preparation will already bring about different functions, delegation of tasks and the creation of a pharmaceutical quality system. 

As explained in Sects. 34.9 and 35.1 the release of pharmaceutical preparations cannot only be based on the assay of the content or on studying the preparation documentation, but has to be based above all on knowledge of and tmst of Pharmaceutical Quality Systems. The reporting... 

Senior management, the boss in smaller organisations, has the ultimate responsibility to ensure effective Pharmaceutical Quality Systems (Chap. 35) are in place, adequately resourced and to assure that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. 

Documentation is a part of the pharmaceutical quality system (PQS) of the organisation, see Sect. 35.6.2. Chapter 4 of the GMP guidelines [1] states that proper documentation is an essential part of quality control. Written information is less prone to errors than verbal information. Moreover, the history of a prepared batch can be retrieved based on the recorded information. 

All process deviations whether planned or unplanned, together with errors and out of specification results should be recorded with a controlled form or electronically onto a database system. Whether a paper system or an electronic system this needs to facilitate the management of the investigation stage, including root cause analysis where necessary, corrective and preventative actions and close out, as well as the data being available for trending (CAPA-system). This is an important part of any Pharmaceutical Quality System, see Sect. 35.6.15. 

The processes of design and preparation of medicines need to be controlled, monitored and continually improved in order to deliver products with the intended quality now and into the future. This may be accomplished in a controlled and structured way using a quality management system (QMS), which for pharmaceutical preparations is more commonly called a Pharmaceutical Quality System (PQS). The implementation of a PQS supports the operations in the highly regulated field of medicinal products. This field is characterised by high-level professional standards and comprehensive requirements to transparency and documentation. 

With the development ICH QIO (see Sects. 35.5.9 and 35.7.4) as a standard for a pharmaceutical quality system, the process approach (maintenance as well as improvement) was emphasised. QIO states as well that a PQS should cover the whole product life cycle. This section describes the product life cycle of medicines, for preparation in pharmacies as well as for industrial production. A medicine whether developed in a pharmacy or in industry is designed to meet the needs of the patient and starts with clarifying that need. The product life cycle consists of a series of processes that need to be controlled and continually improved in order to deliver products with the intended quality. 

A PQS usually covers the distribution process as well. GMP (see Sect. 35.5.7) specifies the distribution being part of the PQS in Chap. 1 Pharmaceutical Quality System ... 

QIO note for guidance on pharmaceutical quality system MRA batch certificate... 

The PQS processes, as well as their sequences, linkages and interdependencies. Process maps and flow charts can be useful tools for clarifying pharmaceutical quality system processes in a visual manner. 

GMP defines in Chap. 1 the responsibilities of Senior Management in a Quality System. It states that Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management s leadership and active participation in the Pharmaceutical QuaUty System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System. ... 

These responsibdities are further elaborated on in QIO by stating that Senior management has the ultimate responsibility to achieve the quality objectives. Management should participate in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system, define individual and collective roles, responsibilities, authorities and inter-relationships of all organisational units related to the pharmaceutical quality system. 

GMP 1 states A Pharmaceutical Quality System appropriate for the manufacture of medicinal products should... 

The way in which Root Cause Analysis (RCA) and a Corrective and preventive action system (CAPA) can be used to improve quality is given by the statement from GMP Chap. 1 Pharmaceutical quality system ... 

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