1. What is Quality Control :
The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. It involves in chemical, physical and some time microbiological testing of a pharmaceutical product.
Quality control involves testing of pharmaceutical products against the specifications.
The other responsibilities of Quality Control are sampling of Raw & packing material, Testing of raw material, packing material, In process, Finished product& Stability batches, Sampling & testing of water, Calibration of Instruments, Preparation of Specification of Raw, Packing, In process & Finished products, Preparation of Standard Test procedure of Raw, Packing, In process & Finished products and reporting of result after analysis & preparation of COA.
2. What is Incident :
Any unplanned or uncontrolled event in the form of non-compliance to the designed systems or procedures at any stage of testing, and storage of drug product due to system failure or equipment breakdown or manual error.
A laboratory Incident is an event in the laboratory that occurs for two primary reasons either due to analyst error or instrument error.
3. What is Deviation:
Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products.
4. What is Good Laboratory Practice (GLP) :
Good Laboratory Practice contains a set of principles that provides a framework within which laboratory studies (Activities) are planned, performed, monitored, recorded, reported and archived. GLP help assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be confidence upon when marking risk/safety assessment.
Good Laboratory Practice contains different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing.
5. What is Column in Chromatography:
A Chromatography column is a device used in chromatography for the separation of chemical compounds. A chromatography column contains the stationary phase, allowing the mobile phase to pass through it. The columns are mostly made of borosilicate glass, acrylic glass or stainless steel.
6. What are the Disintegration Time of tablets :
- Uncoated Tablet 15 min as per BP
- Uncoated Tablet 30 min as per USP
- Sugar Coated Tablet 60 min as per BP
- Film Coated Tablet 30 min as per BP
- Plain Coated Tablets DT in specific medium for 30 min as per USP
- Enteric Coated Tablets DT in simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per USP.
- Dispersible Tablets 3 min ( 15- 25º C ) as per BP.
- Effervescent Tablets 1 tablet in 200 mL water for 5 min ( 15- 25º C )
- as per BP
- Buccal Tablets 4 hrs as per USP.
- Soluble Tablets 3 min ( 15- 25º C ) as per BP.
- Chewable Tablets are not require to comply with test
7. What is Friability Test of Tablet & friability calculation :
Friability is defined as the percentage of weight loss of powder from the surface of the tablets due to mechanical action and the test is performed to measure the weight loss during transportation.
Friability (%) =W1– W2/W1X100
Where,
W1 = Weight of Tablets (Initial / Before Tumbling) &
W2 = Weight of Tablets (After Tumbling or friability)
Limit : Friability (%) = Not More Than 1.0 %
Tablets with individual weight equal to or less than 650 mg then take the sample of whole corresponding to as near as 6.5 gram equivalent and tablets with individual weight more than 650 mg then take sample of 10 whole tablets to perform friability test. Tablets must be de-dusted prior to and after use.
8. How dissolution test is Performed :
The drug is placed within the medium in the vessels after it has reached sufficient temperature and then the dissolution apparatus is operated. Sample solutions collected from dissolution testing are commonly analyzed by HPLC or Ultraviolet–visible spectroscopy.
9. What is Infrared Spectroscopy :
The infrared spectrum of a sample is recorded by passing a beam of infrared light through the sample and when the frequency of the IR is the same as the vibrational frequency of a bond or collection of bonds, absorption occurs. Examination of the transmitted light reveals how much energy was absorbed at each frequency (or wavelength). This measurement can be achieved by scanning the wavelength range using a monochromator.
10. What is limit of Quantification (LOQ) :
The quantification limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantification limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.
Based on visual evaluation: The detection limit is determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be quantified with acceptable accuracy and precision.
