Top Asked Pharma Packing Questions for the Interview

The packaging of drugs is a very crucial part because the safety of drugs is a must at every stage from manufacturing to packaging. Packaging helps the drugs to prevent from the external environment. Today, there are numerous job opportunities available in the pharmaceutical field, providing you with various options to shape your career in the pharma industry according to your interests. To assist you, we have compiled a list of Pharma Packing Questions with answers. Check it out below:

Pharma packaging has a significant opportunity for growth, but you need to be well-prepared before entering this field. We have compiled a list of all questions related to Pharma packing/production. These questions and answers are prepared based on the fresher as well as experienced individuals which is generally asked in pharmaceutical interviews. These Packing questions along with answers focused on area, machinery, and technical rounds.

NOTE- More Pharma Packing Questions will be added regularly, so visit again:

Packing Questions for Freshers:

Q1: What are the Packing and types of packaging in pharmaceuticals?
Ans: Packing is an art and technology of enclosing or protecting products for distribution, storage, sales, and use.

Packing is mainly of three types as below:

• Primary packaging: Primary packing is the material that carries the drug product or fills the drugs inside.
• Secondary packaging: Secondary packing encloses the drugs inside the carton, bottle, etc.
• Tertiary packaging: A Tertiary is used for bulk handling of drugs like storage in a warehouse.

Q2: What is the objective of packaging?
Ans: The primary purpose of drug packaging is the protection of drugs from;

• Physical protection
• Barrier protection
• Containment or agglomeration
• Security
• Portion control
• Convenience.

Q3: What is the primary Packing material used for the blister pack?
Ans: Lidding foils like aluminum foil, paper aluminum foil, and glasin paper foil.

Base foil- PVC( polyvinyl chloride) and PVDC (polyvinylidene chloride).

Q4: What are the Advantages and Disadvantages of PVC?
Ans: Advantage: Low cost and Ease of thermoforming

Disadvantage: Poor barrier against moisture ingress and oxygen ingress.

Q5: How do we overcome the lack of barrier properties of PVC?
Ans: To overcome this PVC coating is done with PVDC/ laminated to PCTFE (Polychlorotrifluoroethylene) or COC (Cyclic olefin copolymers) to increase protective properties.

Q6: What are WVTR and OTR?
Ans: WVTR is the water vapor transmission Rate.

OTR is the oxygen transmission rate.

Q7: What are the WVTR and OTR of PVC?
Ans: WVTR 250 Micro PVC =3.0g/m²/day at 38 °C/90% RH.

OTR around =20 ml/m²/day.

Q8: What is GSM?
Ans: GSM is Gram per square meter, coating of PVC expressed in GSM, more GSM means more barrier property against moisture and gases.

Q9: How to take a sample for GSM?
Ans: Take a foil size in shape (it’s about 15X15), Finally cut it to weigh, and calculate GSM as per Formula.

Q10. How to calculate GSM?
Ans: Weight of sample ✕ 1000/ Area of the sample

Q11: What are thermoforming and cold forming?
Ans: Thermoforming– PVC/PVDC passage through a heating station, then PVC/PVDC took the desired shape at a temperature of around 115°C to 130 °C. The heating temperature may vary according to pocket size and shape.

Cold forming is the formation of pockets without heating PVC. Cold-forming PVC is soft and made of aluminum between PVC and polyamide.

Pharma Packing Questions for Experienced Professionals

Q12: What is name of the machine used for blister pack and strip pack?
Ans: BQS (blister quickly through servo) and elmach are mainly used in the case of product packs by using PVC/PVDC material. ALU-ALU(arithmetic logical unit) machine used for strip packing(aluminum foil used for both sides)

Q13: Tell the names of Dismantle parts of the blister machine?
Ans: The following are the dismantled parts of Packing Machines:

• Forming dia set
• Web index Roller
• Channel
• Guide track
• CSR
• Heater (PSR)
• Printing (BCP)
• Printing gears
• Perforation guide track
• Perforation tool
• Embossing tool
• Punching tool
• Cutting gears
• Sealing gear
• Punching indexing roller

Q14: What are the Different types of machines used for tablets in Primary Packing?
Ans:

• Blister machine eg. alu-alu (BQS), elmach EPI 2000,2500,3010,3015 and 3522 grand etc.
• Stripe Packing Machine.

Read Also: BQS Machine Interview Questions and Answers

Q15: Some important Terms and full forms
Ans: BFR– Blister forming Roller
CSR– Counter Sealing Roller
PHR– Peripheral Heating Roller
PSR– Pressure Sealing Roller
BCP– Batch Coding and Printing
PRC– Print Registration control,

Q16: How do we check the dispensing of raw and packing materials?
Ans: Follow FEFO (First expiry first out) rule, AR.No. (analytical report number), the quantity of material, product code, and affix of approved labels from quality control.

Q17: What is Pharmaceutical barcode system?
Ans: A Barcode is an image of lines and lines denoted with a specific number; lines may be thick, wide, or thin lines.

The code represents a sequence of lines for a particular number. A bar code symbol typically consists of five zones, a quiet zone, a start character, data digits, a stop character, and another quiet zone.

Q18: Tell me about Track and Trace system in pharmaceuticals
Ans: Track and trace systems are effectively used for serialization in pharmaceuticals, identification, and prevention of counterfeit drugs throughout the supply chain.

Q19: What is the Difference between 1D, 2D, and 3D Bar-code?
Ans: The difference between 1D, 2D, and 3D Bardcode in Pharmaceuticals is as Follows:

1D BARCODE:

ID Barcode is Also called one dimension barcode and consists of a parallel linear line with a white background. it stores 8-15 character data information.

2D BARCODE:

2D Barcode is Also called two dimensions or matrix barcode having box types structure. it can store up to 2000 characters.

3D BARCODE:

Uses the peak of the lines to insert information. The information in the 3D barcode is mostly correct and can’t be seen by the eye. This makes it tamper-proof and a great aid for business setups. 3D barcode is a superb resolution for rectifying varied issues, like inaccurate valuation, inventory errors, and overstocking, which are common in the case of 2D barcodes.

Q20: Explain 2D Barcode
Ans: It looks like squares or rectangular with small dots.

Q21: How many sensors were used in the BQS machine?
Ans:

• Lidding foil sensor
• Sensor for forming foil
• Inlet water sensor
• Hopper sensor for checking product level
• Heating plate sensor

Q22: What is the name of Sensors used in the cartonator machine?
Ans: Product magazine sensor, product count sensor, carton call, low carton call, pusher call, loading safety, a sensor for rotary, the in-counter sensor for the position, hand-wheel sensor, hand wheel out sensor, and empty carton rejection sensor.

Q23: What is the Principle of Blister packing machine (BQS)?
Ans: BQS (in the case of the heating plate and sealing plate) works on the Principle of flat sealing and flat forming.

Blister machine (in the case of the heating plate and sealing Roller) works on flat forming and roller sealing.

Q24: How Many Servo motors are in the Blister machine?
Ans: Blister Quick Through (BQS) has a total of 5 servo motors:

• Main cam
• Feeding drum
• Printing drum
• Puller drum
• Punching cam

Q25: How many Challenge tests for the Camera vision system?
Ans: challenge test for Empty cavity, Broken Tablet, Discolored tablet, and foreign Particles.

Q26: How do Thermal Test for thermally affected Blisters?
Ans: Stop the machine and mark all the blisters that are contacted with a hot or sealing plate / Roller with a marker. Ensure that all contracted blisters are rejected.

Q27: What is knurling?
Ans: Dots are found on blister /strips, which come during sealing of blister/ Strips due to the presence of dots on the Sealing plate/Roller. Knurling prevents the failure of leak tests and also contributes to maintaining good-quality blisters.

Q28: What are the Types of knurling in Pharmaceutical Packaging?
Ans: Knurling types: Cross net type, dot type, and Diamond shape

Q29: What is stiffener, and why is it used?
Ans: The presence of extra empty pockets or grooves on the Blister is known as a stiffener and is used to protect products from getting damaged during Packing and transport

Q30: Which Test is done to test for PVDC?
Ans: The morpholine test is done for checking the PVDC layer, use one drop of morpholine solution on either PVDC to check the property if the color of the foil changes to yellowish it means it passes the Test.

Q31: What does NFD stand for?
Ans: NFD stands for non-fill detector

Q32: What is the Role of a Pinhole detector?
Ans: The pinhole detection system is used to identify holes as small as 25 microns (0.001 inches). It has high infrared-sensitive radiation to detect a very small hole.

Q33: Tell the name of the Ink used to detect leakage in the Blister
Ans: Methylene blue solution is used to detect leakage in the blister.

Q34: What percentage of the methylene solution is required to detect a leak test?
Ans: The percentage of use is 2% v/v.

Q35: How many blisters/strips were used for the leak test?
Ans: It depends on the number of pockets present in sealing plates/rollers.

Q36: What is the frequency of replacing water in the leake teat apparatus?
Ans: Water shall be replaced daily.

Q37: How much vacuum is required for the check leak test?
Ans: The standard vacuum used for leak test apparatus is 280±10. It may vary from region to region.

Q38: How do we challenge test for the Leak test apparatus?
Ans: Puncher the blister/strips with the help of a small sharp needle and perform the leak test process, then visually check by opening the blister/strips. If the tablet is found to leak Means the Test is a pass.

Q39: How to discard tablets used for Leak test?
Ans: Whenever doing a leak test, put all the tablets/capsules in a designated S.S Container (with a label). At the end of the shift/ product, collect all non-recoverable in a polybag with a proper label on it, weigh them, and discard all the tablets/Capsules by pouring them into drain point in the washing area.

Q40: Why Tablets/ Capsules are not used for reprocessing and Repacking?
Ans: We can’t use these tablets/capsules because the integrity might fail due to the negative vacuum pressure applied during leak testing. Although regulatory agencies do not prefer reprocessing/repacking after leak testing.

Q41: What is the frequency of the leak test?
Ans:

• Start of batch and then after every one hour
• After the change of printing./PVC/pvdc foil.
• After every break
• At the start of the shift
• After power failure

Q42: The setting of weight limit for cartons
Ans: Take an individual 20 cartons weight and calculate avg. Weight of 20 cartons, now take half the weight of blister/strips and leaflets (lower in weight).

Q43: How to calculate the minimum and maximum weight of the carton:
Ans: Minimum weight: standard weight of carton- 50% weight of blister/leaflet (lower in weight)

Maximum weight: standard weight of carton+ 50% weight of blister/leaflet (lower in weight)

Q44: What is the standard die depth of forming Roller?
Ans: In case of PVC: For flat forming and sealing- 12mm
In the case of Alu- Alu: Cold forming- 09mm

Q45: What Rubber Stereo Size is used in Pharmaceutical Packing?
Ans: Generally, the rubber stereo size used is 1.75 to 2.5mm.

Q46: What Types of Rubber Stereo Used in Packing?
Ans: Flat and Groove

Q47: Monthly Calibration of weighing balance is done for?
Ans: Monthly Calibration of weighing balance is done for Accuracy, Reproducibility, and Eccentricity.

Q48: Why do we calibrate weighing balances?
Ans: Calibration is done to measurement accuracy of the instrument compared to specified limits.

Q49: Defects Related to Blister Pack
Ans: Empty Blister, cut pocket, knurling defects, printing defects on foil, overprinting defects, embossing defects, pocket cut, I mark defects, cutting defects, and pinhole.

Q50: Validation criteria for batch packing
Ans: Validate the batch as per the given validation protocol. Some common criteria are:

• High forming, high sealing, and low machine speed.
• Low forming, Low sealing, and High machine speed
• Moderate forming and sealing with moderate speed
• Perform in-process and leak tests at every stage and fill in details in BPR.

Q51: How to create a batch in a camera vision system
Ans: Read SOP for the Camera vision system and pinhole detector

Q52: Which coating is done on Heating drums and their purposes?
Ans: Teflon coating.

Q53: Why is Teflon coating on Heating Drums is effective for Packaging Pharmaceutical Products?
Ans: Teflon coating is done to prevent the sticking of thermoplastic foil with a heating roller or plate.

Q54: What documents are checked before starting a packing operation?
Before starting packing, verify the following:

• Batch Packaging Record (BPR) is issued and approved.
• Packing materials are released by QA and approved by QC.
• Filling of Log book for issuance and dispensing of Primary and secondary packing from warehouse.
• Check that all logs are filled, especially RH and temperature monitoring activity.
• Check BMR and report from QC for packing activity readyness.
• Records for all Area cleaning log books must be filled.
• Check that the equipment is cleaned, calibrated, and put the “Under process” status label.
• Environmental conditions (temperature, humidity, lighting) are within limits
• Check for Printed monocarton (in case of offline overprinting), (DGFT, labels are ready?)
• Check for all machine HMI product details are filled.

Q55: What is line clearance in pharmaceutical packaging, and why is it important?
Line clearance is important for verifying that a packaging line is free from any previous materials, documents, or remnants. It prevents mix-ups, cross-contamination, and label errors. Line clearance must be performed by Production and verified by QA.

Q56: How do you handle rejected packaging materials during a packing operation?
Rejection during the packing activity is a common thing, but it should be within limits. All rejected material should be stored in dedicated container along with “Rejection” label. All the rejection from primary and secondary must be reconciled at the end of batch for accountability.

Q57: What is packaging material reconciliation, and how is it done?
Reconciliation is necessary to match the quantity used, rejected, and returned at the end of batch.

Total issued Quantity = Quantity used + Quantity rejected + Quantity returned. Check the limit for in-house SOP.

Q58: What should you do if additional packing material is required beyond the standard quantity?

When packing material consumption exceeds the standard quantity for a batch:

• Raise an additional packing material requisition using the additional packing material request form attached with BPR or using ERP system.
• Get authorization from department executive or head, and finally from QA department.
• Send the authorized requisition to the warehouse for dispensing
• Check the materials for Product name, Batch no., Quantity, AR number on dispensing label.
• Transfer the dispensed material to the primary or secondary packing area and record it in BPR.

Q59: What is the role of QA during pharmaceutical packaging operations?

• Line clearance verification and approval
• Online In-process checks (for example, Blister sealing, knurling, leak test, pin hole test, camera detection test, and print quality)
• Review of online BPR entries for completeness and accuracy
• Sampling for in-process testing
• Approval of deviation reports and CAPA
• Batch record review and release after packing completion

Q60: What in-process checks are performed during blister packaging?
Read: SOP for in-process check

Q61: What is the importance of coding and printing verification in pharmaceutical packaging?
Coding and printing verification is done to check Printed information — batch number, manufacturing date, expiry date.

• Perform first-piece verification with QA sign-off
• Conduct in-process checks within the given time interval.
• Use vision systems or manual verification based on validated procedures

Q61: What is the importance of coding and printing verification in pharmaceutical packaging?
Ans: Coding and printing verification is done to check Printed information — batch number, manufacturing date, expiry date.

• Perform first-piece verification with QA sign-off
• Conduct in-process checks within the given time interval.
• Use vision systems or manual verification based on validated procedures

Q62: How do you handle a packaging deviation during production?
Ans: Way to handle the deviation process in Pharmaceutical:

1. Immediately stop the machine activity.
2. Report immediately to QA department within time frame or as per the company SOP.
3. Record the deviation details, including date, time, name of person who observed, and department name.
4. Assess the impact on product quality and regulatory compliance.
5. Do the Root cause analysis to identify the 5M (man, machine, material, method, and mother nature using the Ishikawa and fishbone diagram.
6. At last, prepare the investigation report and CAPA report.
7. QA will analyze the final cause and further take the step for deviation closer.

Q63: What is the procedure for destruction of excess printed packaging materials?

Ans: Check for the Rejection label on machine, shredding the excess materials — labels, cartons, inserts, take QA department authorization, and Record destroyed quantities in the BPR.

Q64: What GMP requirements apply to packaging equipment qualification?

Ans:

IQ: It needs to confirm that equipment is installed correctly per protocol specifications.
OQ: It is performed to Verifies equipment operates within set parameters.
PQ: PQ is performed to know is the equipment is consistently performing throughout under actual conditions.

Q65: At what stage is Requilification required for packing equipment?
Ans: Requalification is required after major repairs, modifications, or relocation.

As per ICH Q9 and (21 CFR 211.63), equipment qualification provides the best scope.

Q66: What is tamper-evident packaging, and when is it required?
Ans: Tamper-evident packaging is used to protect the product from unauthorized alteration and misuse. The US FDA requires tamper-evident packaging for all OTC drug products under 21 CFR 211.132. For patient safety and anti-counterfeiting measures.

Q67: What is the difference between a label and a leaflet in pharmaceutical packaging?
Ans: A label is used or directly affixed for the identification and to know about the current stage of any process, product, or material. It includes product name, batch number, mfg. date, expiry date, and stage.

A leaflet (package insert or PIL — Patient Information Leaflet) are inserted inside the secondary pack with full prescribing information, indications, contraindications, and patient instructions.

Q68: What is important for a fresher to know about GMP documentation in packaging?
Ans: If you are a fresher, the following GMP requirements must be known:

• Record entries at the time of activity (online filling of logs and BPR) — never do entries in the past and advance date and time.
• Use authorized writing pen as per the SOP; no pencil entries in GMP records. Any correction must use a single line strikethrough with initials, date, and reason — never use correction fluid
• Every entry must be signed and dated by the person performing the activity.

Note: More Pharma packing questions for the interview will be added soon here. Comment if any Questions to get an answer, and also share valuable information. Comment below if you need Packaging Questions related PDF.

References:

• ecfr 211.132 Tamper-evident packaging requirements
• ICH Q9 for equipment Qualification