By Y. Tamkosch. Gonzaga University.
Companies tag drug pallets or other bulk packages with radio frequency tags buy duphalac pills in toronto, for example buy cheap duphalac 100 ml on line, but use barcodes or other identifers on smaller units (Lefebvre et al generic duphalac 100 ml on-line. Nevertheless, consumers and governments have demanded a stronger chain of custody (DeCardenas, 2007). This problem has been lingering for years and should be addressed promptly (Palmer, 2012). Without a clear federal mandate on the problem, companies and state governments work in a state of uncertainty, not knowing where and how to make the neces- sary investments that track-and-trace will require. If Congress does not set a mandatory requirement, then the competing demands of state track- and-trace systems will create an unmanageable burden for manufacturers, wholesalers, and retailers. Stakeholder comments on the workshop mentioned the importance of track-and-trace and “the need for one standard, without variations imposed, for example, by individual states” (Ducca, 2011). Any track-and-trace system will be an expense to manufacturers and industry, but the expense can be contained by making one national requirement. An increased track-and-trace requirement will put a fnancial burden on these companies, even if the added cost is low. This can help control the burden an inevitable shift to drug tracking will put on these businesses. Tracking primary packages through the drug distribution chain with unique serial numbers is a good defense against criminal infltration (Ludwig, 2012; Pellek, 2009; Power, 2008). A method of tracking medi- cines from the factory to the consumer could greatly reduce the chances of a dangerous product being sold at a reputable pharmacy. These solutions are of limited value in the vast pharmaceutical gray markets, however. Ig- norance, convenience, and desperation, or some combination thereof, drive patients to unlicensed pharmacies in street bazaars and on the internet. Medicines retail, the last leg of the drug distribution system, is often the most chaotic. The risk increases as drugs move farther from the manufacturer en route to the vendor. Licensed pharmacies and dispensaries can control the quality of their stock, at least insomuch as they can trust their wholesalers. They may approach medicines dispensing as any other sales job and not want a customer to leave without making a purchase. In general, these vendors exploit the chaos inherent to street markets and dry goods shops in low- and middle-income countries and to online drug stores in middle- and high-income ones. Their stock is poor because the stockists are either unable or unwilling to judge quality. Their customers are similarly ill-equipped to evaluate the dangers of buying medicine outside of controlled chains. Unlicensed medicine vendors fll a need, especially in poor countries, when time, expense, and distance impede access to registered pharmacies. Internet pharmacies can fll a simi- lar void, appealing to customers eager to save time and money or to pur- chase discretely. Both types of market are dangerous and more similar than they may appear at frst glance. A Chinese military pharmacist described the appeal of unlicensed medicine shops: “There are people who choose to seek medical help from these places, possibly because of lower prices or privacy concerns, which may increase their chances of getting counterfeit products” (Quingyun, 2012). The observation is true of all unregulated Key Findings and Conclusions • There are few high-quality, licensed drug shops in developing coun- tries, especially outside of cities. Task shifting and vocational training in medicines retail can alleviate the shortage of pharmacists. Only 7 percent of countries have a system for verifying legitimate online drug stores. The committee believes some changes to medicines retail could improve the world’s vast and disorganized pharmaceutical bazaars. Unregistered Pharmacies in Low- and Middle-Income Countries The packaging of falsifed drugs contains clues that are lost in un- regulated pharmacies (Dondorp et al. Epidemiological research suggests that falsifed medicines are often sold without packaging (Basco, 2004), by street vendors (Tipke et al. The dangers of these vendors are clear: Some sell loose pills from large plastic bags or cut apart and subdivide blister packs; none has training in the proper storage, buying, or dispensing of medicines. Even when packaged medicines happen into these markets, their customers are not often sophisticated enough to analyze packages for irregularities. Illiteracy is a known predictor of buying falsifed and substandard drugs (Erhun et al. As David Peters and Gerald Bloom observed, “The wealthiest people in developing Medicine for sale in a Côte d’Ivoire street market. Shortage of Quality-Assured Drug Shops A simple lack of alternatives pushes the poorest consumers to buy medicine at unregulated shops. High taxes and overhead costs make a diff- cult business environment for pharmacists; there are few incentives to work in underserved areas (McCabe, 2009). Research on drug shops in rural Tanzania found that despite gross regulatory violations, including stocking of controlled medicines, selling loose tablets, selling of unregistered drugs, and near universal lack of qualifed staff in sales, the shops operated with the government’s tacit permission (Goodman et al. The regulatory authority might not have enough inspectors to monitor all drug shops on the prescribed timetable (Goodman et al. The Ghanaian Pharmacy Council, for example, inspects only about 20 percent of all drug sellers annually (Segrè and Tran, 2008). Inspectors commonly fnd the shops selling restricted medicines, the products that bring in about half of the stores’ total revenues (Segrè and Tran, 2008). The low likelihood of being caught in a violation and the social and fnancial in- centives to ignore regulations outweigh the threat of punishment for many shopkeepers (Segrè and Tran, 2008). When infrequent inspection does identify violations, regulators are loath to enforce the rules, as this would remove from many communities their only medicine store (Goodman et al. People in rural areas use these shops for more than just retail; the shopkeepers are a source, sometimes the sole source, of health advice in their communities (Anderson et al. In some parts of the world, so-called pharmacy assistants may have less than a middle-school education (Goel et al. These shopkeepers are not properly trained for medicines retail, let alone patient counseling.
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Whether its report includes Conclusion / Summary, description of the performed assay, Data tables, Results, Conclusions, Protocol reference, Revision and approval signatures. In the case of water for injections systems, are the daily sampling records of at least one usage point available, with all the usage points sampled weekly? Whether report contains Summary, Description of performed tests/assays, Obtained data tables, Results, Conclusions, Installation diagrams, Revision and approval signatures. Whether report contains Summary, Description of performed tests/assays, Obtained data tables, Results, Conclusions, Revision and approval signatures. Whether report contains Summary, Description of performed tests/assays, Obtained data tables, Results, Conclusions, Revision and approval signatures. Does the protocol define the selection criteria for products or groups of products subject to cleaning validation? Is data produced supporting the conclusion that residues were removed to an acceptable level? Please specify whether the Validation Strategy include contamination risks, equipment storage time, the need to store equipment dry and sterilize and free of pyrogens if necessary? Whether validation 1 records include Recovery study data, Analytical methods including Detection Limits and Quantification Limits, Acceptance Criteria, Signatures of the Quality Assurance Manager, employee in charge of cleaning and the verification from Production and Quality Control. Name of product (i) Generic Name (ii) Brand Name (iii) Dosage Form (iv) Strength 2. Stability studies (i) Accelerated (ii) Real Time (iii) Whether the expiry date assigned on the basis of stability study? Manufacturers should ensure that qualification and validation are performed; all necessary resources are provided, including appropriately qualified and trained personnel; adequate premises and space; suitable equipment and services; appropriate materials, containers and labels; approved procedures and instructions; suitable storage and transport; adequate personnel, laboratories and equipment for in process controls; instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided; operators are trained to carry out procedures correctly; records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected; any significant deviations are fully recorded and investigated; records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; the proper storage and distribution of the products minimizes any risk to their quality; a system is available to recall any batch of product from sale or supply; complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products to prevent recurrence. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized. The key elements of a qualification and validation programme of a company should be clearly defined and documented in a validation master plan. Any aspect of operation, including significant changes to the premises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated. An on-going programme should follow their first implementation and should be based on an annual review. The commitment to maintain continued validation status should be stated in the relevant company documentation, such as the quality manual or validation master plan. A written report summarizing the results recorded and the conclusions reached should be prepared and stored. Processes and procedures should be established on the basis of the results of the validation performed. It is of critical importance that particular attention is paid to the validation of analytical test methods and automated systems. If a product defect is discovered or suspected in a batch, consideration should be given to whether other batches should be 138 checked in order to determine whether they are also affected. In particular, other batches that may contain reprocessed product from the defective batch should be investigated. Complaints records should be regularly reviewed for any indication of specific or recurring problems that require attention and might justify the recall of marketed products. The authorized person should be responsible for the execution and coordination of recalls. He/she should have sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency. All licensing authorities of all states to which a given product has been distributed should be promptly informed of any intention to recall the product because it is, or is suspected of being, defective. The report should include; (a) Self-inspection observations; (b) Evaluation and conclusions; (c) Recommended corrective actions. The company management should evaluate both the self-inspection report and the corrective actions as necessary. The duties of responsible staff may be delegated to designated deputies of a satisfactory qualification level. Key personnel include the head of production, the head of quality control and the authorized person. In large organizations, it may be necessary to delegate some of the functions; however, the responsibility cannot be delegated. Their education should include the study of an appropriate combination of: (a) Chemistry (analytical or organic) or biochemistry; (b) Chemical engineering; (c) Microbiology; (d) Pharmaceutical sciences and technology; (e) Pharmacology and toxicology; (f) Physiology; (g) Other related sciences. They should also have adequate practical experience in the manufacture and quality assurance of pharmaceutical products. In order to gain such experience, a preparatory period may be required, during which they should exercise their duties under professional guidance. The scientific education and practical experience of experts should be such as to enable them to exercise independent professional judgement, based on the application of scientific principles and understanding to the practical problems encountered in the manufacture and quality control or pharmaceutical products. The heads of the production and quality control generally have some shared, or jointly exercised, responsibilities relating to quality. The head of the production generally has the following responsibilities: (a) to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality; (b) to approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation; (c) to ensure that the production records are evaluated and signed by a designated person; (d) to check the maintenance of the department, premises, and equipment; (e) to ensure that the appropriate process validations and calibrations of control equipment are performed and recorded and the reports made available; (f) To ensure that the required initial and continuing training of production personnel is carried out and adapted according to need. The head of the quality control generally has the following responsibilities; (a) to approve or reject starting materials, packaging materials and intermediate, bulk and finished products in relation with their specification; (b) to evaluate batch records; (c) to ensure that all necessary testing is carried out; (d) to approve sampling instructions, specifications, test methods and other quality control procedures; (e) to approve and monitor analyses carried out under contract; (f) to check the maintenance of the department, premises and equipment; (g) to ensure that the appropriate validations, including those of analytical procedures, and calibrations of control equipment are carried out; (h) to ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to need. The authorized person from Quality Assurance is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale.