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Because of the multi-layered system: strict regulations (cGMP), rigorous supplier checks, precise processes, extensive in-process and final product testing by QC, meticulous documentation reviewed by QA, and oversight by government health authorities who inspect the plant regularly.
This is a "deviation." Production stops immediately. QA investigates the root cause thoroughly. The batch might be rejected or reworked (if possible and approved). Corrective actions are implemented to prevent recurrence. It's taken very seriously.
It varies hugely! A simple tablet batch might take days. Complex products requiring long-term stability testing can take weeks or even months from start to final release. Quality testing adds significant time.
It can be demanding due to the high stakes (patient safety), strict regulations, need for absolute precision, and frequent audits. Attention to detail is critical. However, it's also often seen as highly rewarding and purposeful work.
A diverse team! * Science: Chemists, Microbiologists, Pharmacists (QC/QA). * Engineering: Chemical, Process, Mechanical, Automation Engineers. * Operations: Technicians, Operators (running machines), Supervisors. * Support: Validation Specialists, Maintenance Techs, Warehouse Staff, IT, HR. * Management. Backgrounds range from high school diplomas (with training) to PhDs, depending on the role.
Medicines directly impact human health and lives. Governments have strict agencies (FDA in the US, EMA in Europe, etc.) to enforce rules (cGMP) ensuring every medicine is safe, effective, high-quality, and consistently made. Non-compliance can mean plant shutdowns or product recalls.
It's proving, with documented evidence, that a process, machine, or system consistently does exactly what it's supposed to do. For example: proving that a sterilization cycle always kills all microbes, or that a mixing process always gives a uniform blend. It's not a one-time thing; it's ongoing.
*QC (Quality Control):* The "testers." They physically run lab tests on materials and products (e.g., "Does this pill dissolve properly?" "Is the dose correct?" "Is it free of bacteria?"). * *QA (Quality Assurance):* The "system guardians." They ensure the rules are followed, review all documentation, approve processes and releases, handle investigations when things go wrong, and manage the overall quality system to meet regulations.
To prove everything was done correctly, safely, and consistently. This "documentation trail" (batch records, test results, logs) is required by strict regulations (like cGMP - Current Good Manufacturing Practice) and is essential for tracing problems, passing audits, and ensuring patient trust.
They have vital jobs! They might help bind the pill together, make it dissolve at the right speed in your body, improve taste/stability, add color for identification, or help the cream spread smoothly. They must be safe and not interfere with the drug.
Through extreme precision at every step: exact weighing, perfectly uniform mixing/granulation, controlled compression in tablet presses, and rigorous testing throughout the process to verify dose uniformity.
*Sterile:* Products injected, used in eyes, or applied to open wounds (like injections, IV bags, eye drops). Made in ultra-clean "aseptic" environments to be completely free of all living microbes. Highest level of control. * *Non-Sterile:* Products taken orally (pills, syrups) or applied to intact skin (creams, ointments). Must be clean and safe, but absolute sterility isn't required.
Contamination (like dust, microbes, or even trace chemicals) could make the medicine unsafe, ineffective, or cause side effects. Strict cleanliness ("contamination control") is non-negotiable for patient safety.
Drug discovery happens in labs. The initial chemical manufacturing (making the pure active ingredient) is often done in separate "API Plants" (Active Pharmaceutical Ingredient Plants). The formulations plant takes that API and formulates it into a usable, stable, safe, and effective final product.
It takes the active drug ingredient (the part that treats your condition) and combines it with other safe, inactive ingredients (like fillers, binders, coatings) to turn it into the final medicine you use – pills, capsules, syrups, injections, creams, patches, etc.
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