Evidence, quality systems continuity

After reviewing model quality systems like ISO, Malcolm Baldrige, or the European Quality Award, it is evident that cGMPs fall short of being a true quality system. They lack many elements common to these quality models such as leadership, planning, process orientation, and continuous improvement. A corollary concern is sometimes expressed that the pharmaceutical business is so regulated that a best practice quality system like ISO is not sufficient. However, a central... 

It is always recommended that OQ is carried out after a service visit. Evidence of continued satisfactory performance during use (PQ) should be obtained from everyday method-related checks (e.g. system suitability testing, calibration and analytical quality control). It is advisable to set up thresholds outside of which the performance of an instrument is no longer acceptable. Each stage of the equipment qualification needs to be fully documented so that the evidence of performance at any given time can be checked. 

The rationale for basing air quality standards on smaller particles is evident from an examination of Fig. 2.12, a diagram of the human respiratory tract. Larger particles that are inhaled are removed in the head or upper respiratory tract. The respiratory system from the nose through the tracheobronchial region is covered with a layer of mucus that is continuously moved upward by the motion of small hairlike projections called cilia. Large particles deposit on the mucus, are moved up, and are ultimately swallowed. 

Top management has provided evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by... 

The purpose of validation is to demonstrate the capability of the water treatment and air handling system to continuously supply the required quantity of water and air with the specified quality attributes. Documented means to provide documented evidence. Validation provides the system owner with the means of assessing when a water treatment and/or air handling system is operating outside established control parameter limits and provides a means for bringing the system back into a state of control. It results in written operating and maintenance procedures for personnel to follow, which in turn helps ensure consistent system performance. 

A great failure routinely exhibited by many internal audit programs is the lack of an internal rating system. The results of every audit should receive a rating, and each audit should be measured against the previous audit(s) in an effort to determine whether or not the firm is making the necessary improvements. Evidence of continued digression or lack of any improvement audit to audit would serve as a very useful quality indicator and real-time alert mechanism for QA to use as part of its product quality assessment and future release decisions. 

Before other functions, e.g. tamper-evidence/resistance, child-resistance, accuracy of delivery, can be discussed, general technical factors associated with ingress and egress need further consideration. Since these are common to seal efficiency (i.e. ingress and egress) and may define seal quality, they were not covered under the headings used earlier. In the example used below a continuous screw threaded container—closure system has been employed as an indication of the typical variables involved. These are listed in Table 11.2 and then briefly discussed. 

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