Interview Questions and Answers for Quality Assurance

Which type of tablets are exempted from Disintegration testing?

Chewable Tablets

What are the common variables in the manufacturing of tablets?

1. The particle size of the drug substance
2. Bulk density of drug substance/excipients
3. Powder load in the granulator
4. Amount & concentration of binder
5. Mixer speed & mixing timings
6. Granulation moisture content
7. Milling conditions
8. Lubricant blending times
9. Tablet hardness
10. Coating solution spray rate

Whether bracketing & validation concept can be applied in process validation?

• Both Matrixing & Bracketing can be applied in validation studies. 

1. Matrixing: Different strength of same product Different size of same equipment 
2. Bracketing: Evaluating extremes Largest and smallest fill volumes Fastest and slowest operating speeds.

What is the difference between calibration and Validation?

• Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. 
• Validation is a documented program that provides a high degree of assurance that a specific process, method, or system consistently produces a result meeting pre-determined acceptance criteria.

What Are Good Manufacturing Practices (GMP)?

• Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of Drug substances and drug products, Medical devices, In vivo and in vitro diagnostic products, Foods
• The term "cGMP" is used by the federal government as current good manufacturing practices. By definition, "cGMP" indicates that the current GMP - which is "state of the art" - can change. "GMP" and "cGMP" are often used interchangeably and essentially they have the same meaning.

Who Enforces Good Manufacturing Practices (GMP)?

• Good Manufacturing Practices are enforced in the United States by the FDA (Food and Drug Administration)
• Good Manufacturing Practices are enforced in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA)
• Good Manufacturing Practices are enforced in Australia by the Therapeutical Goods Administration (TGA)
• Good Manufacturing Practices are enforced in India by the Ministry of Health, multinational and/or foreign enterprises, and those individuals in the following positions:

Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly.

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List Out the Appearance Defects of Tables During Compression Activity

1. Capping: ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling. 
2. Laminating: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
3. Sticking/filming: ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation
4. Cracking: Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
5. Chipping: ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
6. Mottling: ‘Mottling’ is the term used to describe an unequal distribution of colour on a tablet.
7. Double Impression: ‘Double impression’ involves only those punches, which have a monogram or other engraving on them.

What is the standard number of rotations used for the friability test?

100 rotations

What is the fall height of the tablets in the Friabilator during friability testing?

6 inches. Tablets falls from 6 inches height in each turn within the apparatus.

Which capsule is bigger in size - size '0' or size '1'?

'0' size

Difference-Out of specification and Out of Trend

Out of specification

• OOS is the comparison of one result versus predetermined specification criteria.
• OOS investigations focus on determining the truth about that one value.

Out of Trend

• OOT is the comparison of many historical data values versus time.
• OOT investigations focus on understanding non-random changes.

Eg: The specification limit of impurity is: Not More than 0.1%,

Case-1: 

For a particular batch, the result obtained 0.11%. This result is out of the specification limit. This is called OOS. An investigation is required. A Fishbone diagram is used for OOS investigation. After identification of the root cause, corrective and preventive measures are to be taken.

Case-2: 

The result obtained 0.08%. Although the results are well within the specifications, we should compare the result with the previous batches trend. If we found the average value of the trend as 0.05%, then this batch result (0.05%) is called out of trend. After identifying the root cause, we can approve the batch.

OOT is to be dealt with on a case-by-case approach. We need to have an understanding and control of the process.

Issuance of Batch Manufacturing Record (by Quality Assurance)

• Based on Production planning, the production manager shall decide on the product and the number of batches to be produced in the month.
• The production supervisor shall raise the requisition for the batches to be taken for the week and forward it to Quality Assurance.
• On receipt of the Batch Manufacturing Record issue requisition, QA personnel will verify the details entered in the requisition form.
• A photocopy of the MASTER COPY of the required Product Batch Manufacturing Record will be taken.
• All the pages of the photocopied sheet of Product Batch Manufacturing Record shall be signed and dated by QA Personnel.
• Check for the correctness of the Batch number by verifying the BMR register.
• Enter the details of Date, Product, Batch No, Batch size, Manufacturing Date, Expiry Date and issued by details in the BMR register.
• Check and allot expiry date by referring to the master list of product shelf life.
• If there is a deviation for change in batch size or any other equipment/process change raise the deviation approval form as per deviation procedure SOP.
• Enter the Batch No. on all the pages of the BMR and get it authorized by QA Manager or in the absence of the QA Executive or QA Officer.
• Insert the signed Batch record in a BMR cover and enter the details of product name, Batch Number, and Batch size. Manufacturing date and Expiry date.
• Batch record along with the Batch Record register shall be sent to production, the production person receiving the batch record should sign on the batch record register to acknowledge the receipt of the batch record.
• QA person who has issued Batch Record shall sign the “issued by” on batch record issue requisition sheet and file the same for future reference.

A sampling of Raw Material Procedure

• On receiving the requisition of the raw material from the store. The QC Chemist will draw the sample from the store with proper safety. If the sample is in a tanker from the outside factory gate.
• The sample will be done by the chemist with equipment such as

1. If the sample is in crystal form & powder form the sample will be taken by SS sample tube.
2. If the sample is in liquid form then the sample will be taken by glass sample tube.
3. If the sample is in the tanker the chemist will take the sample from each compartment of the tanker to the bottom. And top of each compartment with the help of a glass sample tube.

• Amount of the sample to be drawn.

1. If the sample is in solid form (like crystal or powder) then 50.0 Gms of the sample is to be withdrawn.
2. If the sample is in liquid form then 250ml of the sample is to be withdrawn.

• Sample to be taken from each batch or lot as per the package label. If the package is less than 10. The sample should be drawn from each & every package is more than 10. Then sample should be taken as per this rule √n + 1.
• After drawing the sample chemist will put the label UNDER TESTING on the package or drums from where the sample has been taken.
• The chemist will bring the sample to the QC lab and test the sample as per the SOP of the testing method.
• If the sample is approved as per SOP then the sample will be approved QC Manager and a test report will be sent to the store in charge and the production charge and the chemist will put the approved label on the package of the new material and remove the under test label.
• If the sample is not passed as per the SOP testing method. The QC Manager will reject the raw material and send the report to the store in charge and plant in charge, after the QC Chemist will put the REJECT label on the package or drum and remove the UNDERTESITNG label.

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