Quality control measures Flashcards
What is quality?
A measure of excellence or a state of being free from defects, deficiencies and significant variations
What is quality assurance?
This is gaining confidence that the required quality of the product or service is satisfactory for its intended use
What is quality control?
A part of good manufacturing practice (GMP) concerned with sampling, testing and specifications
Why is quality control important in pharmaceuticals?
It is important because it is used to consistently manufacture and deliver zero-defect products to the patients. This is important for efficacy, safety, quality and compliance
What is quality control required for?
All raw materials, packaging components, finished product
What is the impact of ignoring medicine quality?
Lack of therapeutic effect such as prolonged illness, death, toxic and adverse reaction, waste of limited financial resources, loss of credibility. It also has impacts on the manufacturing process, packaging, transportation and storage condition
What is quality metrics?
A measurement standard by which efficiency, performance, progress compliance or quality of a process, a product can be assessed.
What is a pharmacopoeia?
A legally binding collection, prepared by a national or regional authority, of standards and quality specifications for selected pharmaceutical products used in that country or region
How can uniformity of dosage units be demonstrated?
By content uniformity (CU) and mass or weight variation (MV)
How can you ensure the consistency of dosage form units?
Each unit in batch should have an API content within a narrow range around the label claim.
What is a disadvantage of content uniformity (CU) testing?
It is usually destructive and consumes resources
What are the non-destructive dosage unit uniformity tests?
Near infrared spectroscopy and mass variation
What are the objectives of quality control in the pharmaceutical industry?
Efficacy, safety, quality, compliance
What does pharmacopoeia focus on?
They focus mainly on assurance of quality of products by various tools of analytical sciences
What is the aim of pharmacopoeia?
To achieve a wide global harmonisation of quality specifications for selected pharmaceutical products, excipients and dosage forms
What is disintegration?
A physical process related to the mechanical breakdown of tablet into smaller particles/granules
What is an in vitro disintegration test?
It consists of placing a dosage form in an immersion medium under defined experimental conditions and measuring the time taken for the dosage form to disintegrate
What is dissolution?
A process by which a solid enters into a solution
What is an in vitro dissolution test?
This is a requirement for all solid oral dosage forms and is used in all phases of development for product release and stability testing. It is a key analytical test used for detecting physical changes in an active pharmaceutical ingredient (API) and in the formulated product
How is crushing strength measured?
Kilograms, newtons, pounds
What is percentage friability?
The percentage weight loss resulting from chipping, abrasion and erosion of the tablets under stress conditions
What are some common manufacturing problems?
Capping, laminating or splitting; sticking, picking and filming; chipping and cracking, binding
What is capping?
Capping occurs when the upper segment of the tablet separates from the main portion of the tablet and comes off as a cap. It can be related to the formulation or the machine
What is lamination?
The separation of the tablet into two or more distinct layers
