18/07/2026
QUESTIONNAIRE FOR PRODUCTION EXECUTIVE — ANSWER KEY
PART A: WRITTEN QUESTIONS (90 marks)
1. What is dispensing? Parameters to check before/during dispensing (10)
Dispensing is the process of accurately weighing or measuring raw materials (active ingredients and excipients) required for a specific batch of a pharmaceutical product, according to the Batch Manufacturing Record (BMR), and issuing them to production in a controlled, documented manner.
Parameters to check before dispensing:
Approved status of the raw material (released by QC, not quarantined/rejected)
Material identity — label, name, and code match the BMR
Batch/lot number, AR (Analytical Report) number and expiry/retest date
Physical condition of container (no damage, contamination, leakage)
Calibration status and accuracy of the weighing balance
Cleanliness of the dispensing booth/LAF and utensils
Environmental conditions (temperature, humidity, differential pressure)
Availability of correct BMR and dispensing checklist
Parameters to check during dispensing:
Correct quantity weighed as per BMR (within tolerance limits)
Double-checking/verification by a second person
Proper labeling of dispensed containers (name, quantity, batch no., date)
Avoiding cross-contamination (one material at a time in the booth)
Recording of actual weight, balance ID, and operator/checker signatures
Proper closing and storage of dispensed material until use
2. Chemical name and sources of vitamins (10)
Vitamin
Chemical Name
Natural Sources
Vitamin A₁
Retinol
Fish liver oil, milk, butter, egg yolk, liver, carrots (beta-carotene)
Vitamin B₂
Riboflavin
Milk, eggs, green leafy vegetables, liver, yeast
Vitamin B₆
Pyridoxine
Whole grains, meat, liver, fish, vegetables, yeast
Vitamin B₁₂
Cyanocobalamin
Liver, meat, fish, eggs, milk (animal sources only)
Vitamin C
Ascorbic acid
Citrus fruits (lemon, orange), amla, guava, green vegetables
3. Ranitidine HCl dispensing (FIFO) — calculation (10)
Requirement: 250.00 kg of Ranitidine HCl (100% equivalent basis)
Since potency varies by lot, the actual Ranitidine HCl content of each lot must be calculated, and material is drawn in FIFO order (Lot A → Lot B → Lot C).
Step 1 – Actual content per lot:
Lot A: 110 kg × 99.50% = 109.45 kg
Lot B: 110 kg × 98.85% = 108.735 kg
Lot C: 100 kg × 98.35% = 98.35 kg (available)
Step 2 – Apply FIFO:
Use all of Lot A: 109.45 kg → running total = 109.45 kg
Use all of Lot B: 108.735 kg → running total = 109.45 + 108.735 = 218.185 kg
Remaining requirement = 250.00 − 218.185 = 31.815 kg (equivalent, to come from Lot C)
Step 3 – Physical quantity from Lot C:
Quantity needed = 31.815 ÷ 0.9835 = 32.35 kg (approx.)
Final Dispensing:
| Lot | Physical Qty Dispensed | Potency | Actual RH Content |
|---|---|---|---|
| A | 110.00 kg | 99.50% | 109.45 kg |
| B | 110.00 kg | 98.85% | 108.735 kg |
| C | 32.35 kg | 98.35% | 31.82 kg |
| Total | ≈ 252.35 kg | — | ≈ 250.00 kg |
Total physical quantity of Ranitidine Hydrochloride to be dispensed from the three lots ≈ 252.35 kg (of which 217.65 kg comes from Lots A+B fully, and 32.35 kg from Lot C, following FIFO).
4. Tooling in compression machine (10)
Tooling refers to the set of punches and dies fitted into a tablet compression machine that shape and compress the granules/powder into tablets of a defined size, shape, and weight.
Components of tooling:
Upper punch – moves down to compress material in the die cavity
Lower punch – supports the material and ejects the finished tablet
Die – hollow cylindrical cavity that defines the diameter/shape of the tablet
Types of tooling (based on machine/turret design):
B-tooling – standard, smaller punch head diameter (for smaller/lighter tablets)
D-tooling – larger punch head diameter, used for larger tablets and higher compression force
Punch parts: tip (embossing/plain, flat/concave/convex), neck, barrel, head, key.
Functions of tooling:
Determines tablet shape, size, weight, thickness, and hardness
Allows embossing/debossing of brand names, scoring lines, break lines
Must be made of hardened stainless steel to resist wear, corrosion, and sticking
5. Capsule sizes and physical specification of empty hard gelatin capsules (10)
Empty hard gelatin capsules are available in 8 standard sizes, numbered from largest to smallest: 000, 00, 0, 1, 2, 3, 4, 5
Size
Approx. Capacity (ml)
Approx. Length (mm)
000
1.37
26.1
00
0.95
23.3
0
0.68
21.7
1
0.50
19.4
2
0.37
18.0
3
0.30
15.9
4
0.20
14.3
5
0.13
11.1
Physical specification/structure:
Consists of two telescoping cylindrical parts – body (longer, narrower) and cap (shorter, wider) that fit over each other
Made of gelatin, water, plasticizer, colorants, and preservatives
Cap locks onto body via a locking ring/groove to prevent premature opening
Should be free from cracks, spots, and should have uniform wall thickness
Moisture content typically maintained around 13–16% for proper brittleness/flexibility balance
6. Categories of pharmaceutical packaging materials (10)
1. Primary Packaging – material in direct contact with the product
Examples: Aluminium blister/strip, bottles (glass/HDPE), ampoules, vials, tubes
2. Secondary Packaging – outer packaging that does not directly contact the product but holds primary pack
Examples: Cartons/mono-cartons, labels, package inserts
3. Tertiary Packaging – used for bulk handling, storage, and transportation
Examples: Corrugated shipper boxes, wooden pallets, shrink wraps, strapping
Classification can also be by material type:
Glass – ampoules, vials, bottles
Plastic – HDPE/LDPE bottles, blister films (PVC/PVDC/Alu-Alu)
Metal – aluminium foil, collapsible tubes, caps
Paper/Board – cartons, labels, leaflets
7. What is a Label? Types of labels (10)
A Label is a printed piece of paper, foil, or other material affixed to the container/package of a drug product that provides essential information such as product name, composition, batch number, manufacturing/expiry date, dosage, storage conditions, and manufacturer details, in compliance with regulatory requirements.
Types of labels:
Container label – on the immediate/primary container (bottle, vial, strip)
Carton label – on the secondary packaging (mono-carton)
Shipper label – on the tertiary/bulk shipping carton (batch no., quantity, storage)
Cautionary/Warning label – e.g., "For external use only," "Keep out of reach of children," "Schedule H drug"
Bar-code/QR-code label – for track-and-trace and anti-counterfeiting
Overprinted (variable) label – batch no., mfg./exp. date, MRP printed at time of packing
8. What is a tablet? Essential qualities of a good tablet (10)
A tablet is a solid unit dosage form prepared by compressing a drug (with or without suitable excipients) into a specific shape and size, intended for oral or other routes of administration.
Essential qualities of a good tablet:
Uniform weight – within pharmacopoeial tolerance limits
Uniform content of active ingredient – content uniformity
Adequate hardness/mechanical strength – to withstand handling, packaging, transport
Low friability – minimal powdering/chipping during handling
Acceptable disintegration time – as per pharmacopoeial limits
Good dissolution profile – for proper drug release and bioavailability
Elegant appearance – uniform color, smooth surface, free from defects (capping, chipping, mottling)
Chemical and physical stability over shelf life
Free from microbial contamination
9. Abbreviations (5)
MHRA – Medicines and Healthcare products Regulatory Agency (UK regulatory authority)
HVAC – Heating, Ventilation, and Air Conditioning
cGAMP – current Good Automated Manufacturing Practice
GDP – Good Distribution Practice
LAF – Laminar Air Flow
10. Dress code and color code — meaning and importance (5)
Dress code: The standard/prescribed set of protective garments (uniforms, head caps, masks, hand gloves, shoe covers, gowns) that employees must wear according to the area/zone they work in (e.g., general area, sterile area, packing area).
Color code: The system of assigning specific colors to garments, equipment, containers, or status labels (e.g., green = approved/cleaned, red = rejected/dirty, yellow = under process/quarantine) to visually distinguish areas, materials, or equipment status at a glance.
Importance in pharmaceutical industry:
Prevents cross-contamination between different areas/zones (e.g., production vs. sterile areas)
Enables quick visual identification of equipment/status/room cleanliness (clean vs. dirty vs. quarantine)
Ensures personnel hygiene and safety, protecting both product and worker
Supports cGMP compliance and regulatory audit requirements
Reduces mix-ups and human error on the shop floor
PART B: MULTIPLE CHOICE QUESTIONS (10 marks)
A — Current Good Manufacturing Practice
D — Assay (not a unit operation; it's a QC test)
B — To monitor and control manufacturing process
B — Aluminium blister
B — To prevent moisture absorption
B — Moisture Analyzer
A — First In First Out
D — All of the above
A — Batch Manufacturing Record
B — Dry granulation (commonly used for moisture-sensitive APIs, since it avoids water/heat)
Total: Part A (90) + Part B (10) = 100 marks
