What is Quality by Design and what does it mean for you?

Traditionally, products were tested only after they were finished. If a batch failed, it was discarded—but the root cause might remain a mystery.

Quality by Design turns this on its head. It means that we build quality into the product from the very first day of research. Think of it like baking: instead of just tasting the cake at the end to see if it’s good, we study exactly how the temperature of the oven, the quality of the flour, and the mixing speed affect the final result. By understanding these factors perfectly, we can guarantee a perfect cake every single time. QbD is a proactive, science-based approach that ensures high quality is integrated into the product from the initial development stages, rather than being tested for after the fact.

For you, this means total reliability. Whether it is your first dose or your last, the medicine you receive is identical in potency and performance.

Why This Matters to You?

• Consistency: You can trust that the medication you buy today is identical in quality to the one you bought last month.

• Reliability: By preventing manufacturing errors before they happen, we reduce the risk of drug shortages and recalls, ensuring your medicine is always available when you need it.

• Ethical Standards: We abide by the ICH Q8, Q9, and Q10 guidelines—the "gold standard" for pharmaceutical quality. Our commitment to QbD is our commitment to you: science-driven, patient-focused, and ethically uncompromising.

How We Implement QbD for Your Safety?

Our implementation follows a rigorous, five-step ethical framework to ensure your medicine is "Right First Time":

1. Defining the Goal (The Patient First): We start with the "Quality Target Product Profile"—a detailed blueprint of exactly how the medicine must perform for the patient to be safe and get the best results.

2. Identifying Critical Features: We identify the "Critical Quality Attributes"—the specific chemical and physical properties (like how fast a tablet dissolves) that are essential for the medicine to work.

3. Scientific Risk Assessment: Using advanced science and data, we map out every step of the manufacturing process to identify anything that could cause a variation. We don't leave quality to chance; we manage it through Quality Risk Management.

4. Creating a "Safe Zone": We establish a "Design Space". This is a scientifically proven range within which our machines can operate. As long as we stay in this zone, we know the quality is guaranteed.

5. Real-Time Monitoring: We use Process Analytical Technology (PAT)—sophisticated sensors that monitor our production in real time. If even a tiny variation is detected, the system adjusts instantly to bring it back to perfection.

How We Deliver Quality Across Our Portfolio?

We apply specialized QbD protocols to each of our core dosage forms to ensure they perform exactly as intended:

1. Precision Tablets

• The Challenge: Ensuring every tablet dissolves at the right speed and contains the exact dose.

• Our Approach: We use Design of Experiments (DoE) to study how different compression forces and ingredient ratios affect tablet hardness and dissolution. This allows us to guarantee that our tablets won't crumble in the bottle but will

  release the medicine precisely when needed in your body.

2. Advanced Capsules

• The Challenge: Protecting sensitive ingredients from moisture and air while ensuring they are easy to swallow.

• Our Approach: We identify Critical Material Attributes (CMAs) for our capsule shells and fillings. By monitoring environmental conditions in real-time, we ensure that every capsule remains stable and effective throughout its shelf life.

3. Pure Oral Liquids

• The Challenge: Maintaining a perfectly uniform mixture so that every spoonful contains the correct amount of medicine.

• Our Approach: For our syrups and suspensions, we focus on Critical Process Parameters (CPPs) like mixing speed and temperature. This prevents the "settling" of active ingredients, ensuring a consistent dose every time without the need for excessive shaking.

Why Our "Non-Beta Lactam" Focus Matters?

Patient safety is our highest ethical priority. We operate a strictly non-beta-lactam facility, meaning we do not manufacture penicillin or related antibiotics that can cause severe allergic reactions in some individuals.

• Zero Cross-Contamination: By dedicating our facility to non-beta lactam products, we eliminate the risk of trace antibiotic residues entering your medication.

• Stringent Hygiene: Our premises follow WHO-GMP and ISO standards, utilising advanced air-handling systems and rigorous cleaning protocols to maintain a pristine environment for your health.

By choosing our products, you are choosing a company that values science over guesswork and integrity over shortcuts. We don't just make medicine; we design quality for your life.