Pharmaceutical Quality Systems

Myth versus Reality: What does ICH Q10 implementation really mean for my company?

Myth: The elements of ICH Q10 Pharmaceutical Quality System (PQS) conflict with good manufacturing practices (GMPs) and the International Organization for Standardization's (ISO) quality management systems.

Table I: ICH Q10 Gap Analysis Checklist

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Reality: They really work together and augment each other. There are certain areas that GMPs don't specifically mention or if they are implicit, Q10 brings them out. What we have announced in the US Food and Drug Administration is an incremental approach to updating our GMPs, not a wholesale change of them. As shown in the ICH Q10 PQS model, GMPs are to be used in conjunction with the pharmaceutical quality system (PQS)....[the diagram] puts in place a way to follow GMPs and to have more holistic coverage because GMPs have always been represented as a minimal standard. ISO 9001 and Six Sigma principles are also consistent with the Q10 document. The important thing to keep in mind is that Q10 was written for pharmaceutical products. —Joseph C. Famulare, deputy director of the Center for Drug Evaluation and Research, FDA

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Myth: My company outsources the bulk of its production, so we don't need a full PQS.

Reality: The sponsor has the ultimate responsibility [of the pharmaceutical product] and the agreement as to how [that product's] quality functions will be carried out and ensured will have to be worked out by the sponsor. An important passage of Q10 indicates that we will look at it as being applied to sites that manufacture products or do whatever part of that manufacturing. So Q10 is applied to sites, but holistically, if you're contracting the entire operation out, you're going to have to ensure that those quality elements are put into place, either through a whole system in your own company or through an agreement to have those systems put in place for you. —J.C.F.

Myth: Following ICH Q10 is optional.

Reality: This is in fact true. ICH Q10 is a guideline in all ICH regions. If you choose to implement Q10, you're implementing something that regulators and industry from the three ICH regions have agreed is a sound approach to a PQS. Q10 is not creating new regulation..., but it does provide guidance on ways companies can better carry out their work. —Gerald Migliaccio, vice-president of Global Quality and Environmental Health and Safety Operations, Pfizer

Myth: ICH Q10 does not relate to good laboratory practices or preclinical testing of materials.

Reality: The guideline can be applied to preclinical testing in the same way it applies to commercial manufacturing, but with an appropriate quality system approach to each stage. [Note: There are charts in the Q10 document that refer to the appropriate level of quality system implementation in the development stage.] —Karen Ginsbury, president of PCI Pharmaceutical Consulting Israel

Myth: Quality systems do not apply to biologics or medical devices.

Reality: With regard to inspections from a US perspective, Q10 applies equally to drugs, biologics, and new products. It is not applicable to device inspections, however, it serves to make the approaches more parallel. —J.C.F.

Myth: My company has not caught up with Q8 or Q9, we can't possibly start implementing Q10.

Reality: While Q8, Q9, and Q10 are intended to be a trilogy, it is possible to implement Q10 without having implemented Q8 (i.e., a company could decide not to adopt quality-by-design [QbD] but to still have a modern, effective quality system with management commitment to quality, policies for risk management, and oversight of outsourcing activities and knowledge management, CAPA, etc). Looking ahead, Q11 Development and Manufacture of Drug Substances, has entered the harmonization process. Q11 is an "enabler" for Q8 Pharmaceutical Development. If active pharmaceutical ingredient manufacturers do not adopt QbD, it is going to be almost impossible for the drug product manufacturer to do so. —K.G.

Source: The above questions and responses were compiled from the June 2008 Quality Systems in a Global Market webcast (4) as well as from questions posed to the webcast panelists after the event.

For more on this topic, seeAll Roads Now Lead to Quality Systems