In the nutraceuticals,
pharmaceuticals, and cosmetics industries, quality
means conformance to standards set by both the manufacturer and the industry.
These standards must not only reflect a strong emphasis on the desired features
of a product but also on its safety and efficacy.
To maintain quality, quality control (QC) procedures are employed. These procedures are in place to identify any action that does not meet the specified standards for quality. As a tool, QC is said to be corrective in nature. Its goal is to find and eliminate where problems in quality originate from. An example of QC in a typical micro laboratory is the regular monitoring of reagents and test samples.
Controls can be reviewed at various stages to prevent errors
and thereby substantiate product safety.
Quality assurance (QA), on the other hand, is managerial in nature. It is defined as the total process of verifying and determining whether the quality of laboratory reports can be guaranteed. QA analysts are tasked to improve test processes so that erroneous reports are prevented. An example of a QA-related task is the development of standard operating procedures (SOPs) in all stages of a microbiological procedure.
Quality assurance (QA), on the other hand, is managerial in nature. It is defined as the total process of verifying and determining whether the quality of laboratory reports can be guaranteed. QA analysts are tasked to improve test processes so that erroneous reports are prevented. An example of a QA-related task is the development of standard operating procedures (SOPs) in all stages of a microbiological procedure.
An efficient quality assurance system in microbiology
testing accomplishes the following:
1. Maintains reliable and timely analytical results
There are three general stages in a microbiology testing: pre-analytical, analytical, and post-analytical. Each of these stages consists of activities that affect results. Interruption at any point in the process can destroy quality.
But with an efficient QA system, the integrity of results is ensured and maintained. Since all materials and equipment are adequately controlled, any error is prevented even before they are committed. Some of these errors include contaminated specimens or culture, usage of non-sterile container, and wrong medium.
2. Maintains the
integrity of the laboratory
Consumers and suppliers trust accurate, unbiased, and reliable results that come from a reputable microbiology lab. QA does its share by ensuring that all policies and protocols in the laboratory are complete, up-to-date, and extensively reviewed by qualified personnel. In an efficient QA system, a director spearheads a team of analysts with assigned tasks and responsibilities. This keeps order in place by encouraging a checks-and-balances system and active participation among the members of the team.
Consumers and suppliers trust accurate, unbiased, and reliable results that come from a reputable microbiology lab. QA does its share by ensuring that all policies and protocols in the laboratory are complete, up-to-date, and extensively reviewed by qualified personnel. In an efficient QA system, a director spearheads a team of analysts with assigned tasks and responsibilities. This keeps order in place by encouraging a checks-and-balances system and active participation among the members of the team.
3. Ensures that only
qualified personnel are allowed to operate
From simple tasks such as checking and recording up to complex activities such as internal audit procedures, QA can be complicated. But with an effective QA program, only qualified individuals are allowed to have access to the laboratory. These individuals have the necessary certification and have undergone continuing education activities to augment their skills.
From simple tasks such as checking and recording up to complex activities such as internal audit procedures, QA can be complicated. But with an effective QA program, only qualified individuals are allowed to have access to the laboratory. These individuals have the necessary certification and have undergone continuing education activities to augment their skills.
Role of Quality Assurance in Testing Dietary Supplements, Pharmaceutical Drugs, and Cosmetic Products
One of the most common problems in drug, dietary supplement, and cosmetic products is microbial contamination. This can lead to major recalls and serious health problems. For the manufacturers, this translates to major losses and decreased consumer confidence.
To cite an example, it can be remembered that back in January 2011, the alcohol prep pads from the Triad Group were recalled because of contamination with Bacillus cereus, a strain of bacteria whose toxins are associated with diarrhea, nausea, and vomiting.
Efficient QA and QC systems should be implemented to prevent these setbacks. Manufacturers must thoroughly test their processes, materials, and techniques to ensure a product that is consistent in quality, safe, and effective.
Contact Biolumix for more
information about rapid
microbiology testing and quality assurance of microbiology labs.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
