Controlling complaints management

The basic structure of the ICH GMP guideline for API production is shown in Table 15. It consists of 19 chapters, which cover the requirements for quahty management, personnel, premises, equipment, documentation, materials, production and process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints, recalls, contract services, cooperators, APIs manufactured by cell culture/fermentation, and APIs used in clinical trials [52]. 

Nonconformance arises when any aspect of the work of a laboratory does not conform to its procedures, to the standard, or the agreed-upon requirements of the customer. These are detected by customer complaints, internal quality control measures, management audits and reviews, and by observations of staff. They must be dealt with under the appropriate part of the management system and fully investigated and reported. 

Supervision of the handling of data by means of an audit trail function Reservation of material and control of the execution of stability studies Assistance in the processing of stability and complaints management, recipes, and reference substances... 

A complaints management module allows the processing of complaints that are caused by internal, external, or manufacturer reasons. Such systems control all steps involved in management of electronic complaints the compilation of addresses of all participants, detailed descriptions of the defects, communication of actions, recording protocols, and setting deadlines. The system provides an automated controlling... 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

Generally, arblockers are considered as second-line agents to be added on to most other agents when hypertension is not adequately controlled. They may have a specific role in the antihypertensive regimen for elderly males with prostatism however, their use is often curtailed by complaints of syncope, dizziness, or palpitations following the first dose and orthostatic hypotension with chronic use. The roles of doxazosin, terazosin, and prazosin in the management of patients with hypertension are limited due to the paucity of outcome data and the absence of a unique role for special populations or compelling indications from JNC 7. 

An active program of surveillance of the quality of the immunostains produced must be defined. The primary elements of such a quality assurance (QA) program include procedures and policies for patient test management, quality control, proficiency testing, comparison of test results, relationship of clinical information to patient test results, personnel assessment, communications, complaint investigations, QA review with staff, and QA records. The documentation and review by the laboratory director of all QA procedures is imperative and cannot be overstressed. A brief explanation of each of the QA elements is as follows ... 

Fortunately, for most psychotropics, side effects are minimal, usually involving nuisance complaints. With some agents, such as clozapine, however, the potential for more serious adverse effects does exist and must be carefully explained to the patient and family. Although managed care has successfully controlled overall financial costs, it is our responsibility to advocate for the optimal delivery of treatment, which necessarily takes into consideration not only the immediate expense of treatment but the impact of appropriate care in the long-term. As importantly, one should always factor in the cost of not providing adequate treatment, including ... 

As shown in Tables 6-8 the Indian GMP regulations consists of eight parts I, IA, IB, IC, ID, IE, IF, and II. Part I covers the general requirements of GMP. It is divided into 29 chapters, which deal with the requirements for personnel, premises, equipment, sanitation, production and process controls, materials, documentation, quality management, validation, reserve samples, recalls, complaints, and self-inspection. Parts IA to IE cover specific requirements for the manufacture of different dosage forms regarding premises, equipment, and methods. Part IA deals with the require-... 

Examples of GxP processes (functions) include supplier management, procurement, goods receipt, materials management, production control, quality control, batch release, distribution, recall, customer complaints, batch tracking, and compliance management (e.g., SOP management, electronic data archiving). 

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