Manufacturing quality control responsibilities

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Pharmaceutical Purity. A safety profile of a generic drug can differ from that of the brand-name product because different impurities may be present in each of the drugs (154). Impurities can arise out of the manufacturing processes and may be responsible for adverse interactions that can occur. For example, serious adverse reactions (Lyell syndrome) were observed upon the use of isoxicam in 1985. These seemed to have resulted from trace elements of a manufacturing by-product that was within the manufacturing quality control specifications. 

Formal approval of the plan, indicating the top-level management for each function, is essential to share the responsibility. The VMP shall be supported with approval signatures from multidisciplinary functions, including Engineering, Manufacturing, Quality Control, Quality Assurance, and Validation at a minimum. 

The creation and operation of such a system and the elaboration and application of the measures involved require the participation of the staff responsible for the different department concerned development, manufacturing, quality control, etc. 

The manufacturer will have carried out a full mathematical investigation into the system vibration response. One quality control requirement will be to establish whether the correct assumptions have been made Rotor assembly and component weights should be obtained during man ufacture and verified against mathematical data used. 

Therefore, if the desired indoor air quality goals are clearly defined, they will benefit the designers, health and safety professionals, manufacturers of control technology equipment, end users, and other experts who are responsible for maintaining a safe and healthy indoor climate. In conclusion, introduction of the target level process for industrial air quality will benefit both the health sector and the production sector. 

The company was a private label manufacturer of home maintenance and personal care products. Its laboratory would be involved with new product development, evaluation of raw materials, testing of competitive products, and quality control. Laboratory personnel would also be responsible for chemical safety in the plant and for proper waste disposal. 

Investigational New Drug (IND) application. The IND petition requires full disclosure of where and how the NME is manufactured and controlled for quality and stability. It also contains proposed analytical methods, pharmacology and toxicology data, and evidence of desired effects in disease models. The application lists proposed chnical investigators and contains complete human subject protocols. Under current regulations the FDA must provide a written response to the sponsor within 30 days after submission. The lack of a timely response is tacit approval for the sponsor to proceed to the clinic. 

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

While the COA is the excipient manufacturer s responsibility, once the material is received, it is the drug product manufacturers responsibility to verify the product and ensure that it is properly tested, handled, and stored. Upon receipt of a shipment, each lot of excipient will be withheld from use until the lot is sampled, tested, or examined according to the written procedures. The quality control (QC) personnel will examine each container for (i) manufacturer s name, (ii) manufacturer s lot number, (iii) leaks or spills, (iv) contamination, (v) breached containers, (vi) proper labeling, and (vii) material safety data sheet and determined material hazards. 

Following approval of the bulk cores by quality control, they are shellac-coated. According to the manufacturing directions, one or two coats may be applied based on the process operator s judgment. A third coat is permissible but only in response to directions from the supervisor. In any event, the actual number of coats applied is recorded in the batch record. Because of its potential impact on drug availability, this information is listed as a critical parameter in Table 3. 

EOQC (1980) European Organization for Quality Control, 4th European Seminar (1980) Validation of Manufacturing Processes (Geneva) [5] Definitions, installation and operational qualification, development and manufacturing phase, responsibilities and organization, use of historical data, change control and revalidation... 

One of the classic cases is the potentiation of the insecticide malathion by another insecticide, EPN, the LD50 of the mixture being dramatically lower than that of either compound alone. This potentiation can also be seen between malathion and certain contaminants that are formed during synthesis, such as isomalathion. For this reason quality control during manufacture is essential. This example of potentiation involves inhibition, by EPN or isomalathion, of the carboxylesterase responsible for the detoxication of malathion in mammals. 

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