The surge of substandard, adulterated, and fake medicine is a global threat. The 1957 thalidomide disaster led the pharmaceutical industry to see an increase in regulation. It is important to have a scientific, systematic, and sustainable approach for commercial drug production to ensure the protection of public health. The most effective way to deal with this problem is to have a quality assurance department that will focus on the provision of suitable systems and will define standard operating procedures (SOP’s).
What is Pharmaceutical Quality Assurance?
- The World health organization defines pharmaceutical quality assurance as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is effective, safe, and acceptable to the patient.
- Within the pharmaceutical industry, this occurs during the clinical, manufacturing, and distribution stages of the product life cycle.
How does a career within QA look like?
Pharmaceutical quality assurance professionals work either in generic or specialist positions. People who have a background in either engineering or health and safety are generally the ones who move into a QA job. If starting in a graduate position within the pharmaceutical industry, the person is required to have a degree in life science. There are a lot of growth opportunities within the quality assurance and a typical career path might look like;
- Quality assurance analyst
- Testers or inspectors
- Quality assurance managers
- Product management
What are the determinants of medicine quality?
The correct API, that is the active pharmaceutical ingredient is present.
The medicine should not be contaminated with potentially harmful substances.
The consistency of shape and size of the dosage form should not vary.
The amount of the active ingredient present in the medicine is correct. Usually between 95 to 110 percent of the labeled amount.
The activity of the medicine should be ensured for the period of time stated on the product label, that is until the date of expiration.
It refers to the speed and completeness with which an administered medicine enters the bloodstream. It should be consistent to provide predictable therapeutic results.
A medicine of good quality meets the standards described in widely accepted pharmacopeia such as Britsh pharmacopeia (BP), International pharmacopeia (IP), United States Pharmacopeia (USP).
How do you get into a role within QA?
Success in any job depends on your skills. The one who constantly improves his or her skills succeeds faster. Experience is also necessary but it is a waste if you have not learned much or developed skills, even if you get to the top level then also you will have to rely on your subordinates for almost everything. With regard to the QA job, prepare a good profile of yourself as it is a must department in every pharmaceutical company, laboratories, and sometimes offices too.
QA is an extremely broad field that refers to any aspect that may affect a drug’s quality during its research, development, manufacturing, and sales phases. The QA jobs and supply chain jobs are closely related and often overlap depending on the product being manufactured and the nature of the business. Scientific qualifications are highly desirable to create a good starting place for a career in pharmaceutical quality assurance jobs. A thorough understanding of current regulations and legislations is imperative to a role within quality assurance. For example; GMP, GDP, GCP, GLP, or ISO standards (9001, 67897). To progress in the quality sector, it is essential to build a good network and reputation, learning the practices, business, and industry inside out, and conducting ethical research.
ZENES BIOTECH (Ayurvedic medicine manufacturers in Haryana)
Address – Naushera building, Kuldeep Nagar, G.T. Road, Ambala Cantt., 133004, Haryana, India
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