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This means that all environmental conditions are within the specifications. There is no difference between moving a location within a city or in another city. We request that a drug transfer form be filled out indicating that the drugs have been properly stored and shipped. The monitor will be co-signed, as will the local and global testing manager and the PQ. Should a PQ look at CROs and investigators or can a QP rely on the GCP auditors of its own company? How can this division of responsibilities be achieved? The PQ can rely on information provided by the GCP auditors. A system has been put in place within JJ to ensure that the PQ is informed if critical problems are observed during a GCP inspection. In this situation, an escalation meeting is organized to decide what to do with the drugs on the ground. What is the best option: will employees who develop the formulation also manufacture PMIs (and will suddenly have to deal with PMPs) or should they switch it to another group that is not very familiar with the formulation, but is familiar with PMPs? Both scenarios are acceptable. Within my organization, Phase 1 material is often produced by the formulation group under the control of quality assurance. They are well trained for these activities. What is the number of regular/normal complaints for pre-filled syringes and auto-injectors? There is no usual claim rate for pre-filled syringes, as the type and use of syringes can vary… But a window can be from 5 ppm to 25 ppm…

It is controversial whether higher rates are acceptable or expected for automotive injectors. Auto-injector can be complex and made up of several components. Failures are to be expected. On the other hand, auto-injectors must reduce the number of abuses of the syringe. Therefore, a slightly higher number of complaints should be acceptable. A product (sterile collyre) meets all specifications. During production, however, some microbiological monitoring results were not OK. Can I release the battery? Microbiological surveillance data do not describe the microbiological status of the lot itself.

Monitoring data is considered information about the controlled environment. A level excursion in micro-surveillance may be an indicator that there are deviations from the usual process, but they do not automatically indicate a microbiological problem of the lot. After a risk assessment of non-compliant monitoring results (type of contamination, level of contamination, location of surveillance, other surveillance data, trend), it may be possible to release the lot. Who should sign the quality agreement? Just the PQ? Qa? Legally? Head of production/QC? Business? Quality agreements should be considered GMP documents. Therefore, the involvement of legal services should be limited to not complicating and extending the process. Following the recent revision of Chapter 7 of the EU`s guide to resource management activities … 7.12 A contract should be developed between the contractor and the contract manager, which would define the responsibilities and communication processes for outsourced activities. The technical aspects of the market should be developed by competent people, who would appropriately deal with outsourced activities and related good manufacturing practices. In the revision of Chapter 2 of the EU`s GMP (staff) guide, it says 2.7 Those responsible for controlling production and quality generally have common or shared responsibilities… – the approval and follow-up of contract manufacturers; In light of these two chapters, I would endeavour to ensure that the production manager and QC sign a quality agreement.