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GMP (good manufacturing practice) for injection is a definite form of quality assurance that is aimed at ensuring that these formulations are produced keeping in conformity to standards appropriate for its intended use. We, at S.G.Biopharm, have adopted GMP approved by WHO (World Health Organization) for reducing the risk involved in production of pharmaceutical goods. We not only manufacture but also are WHO GMP approved exporter for injection in India.
The risks involved in preparing injections are two fold: mix-ups or cross-contamination, and inaccurate labeling. Either of these is risky both for the patient and the manufacturer. From our side to eliminate any such risks, we take adequate safety precautions at each level of drug production. Quality management is an exhaustive process and involves several steps. In addition to processes involved, great care is taken to maintain a thoroughly sanitized and hygienic environment.
Contamination free production process – We maintain a totally contamination free production process at our factory. Our entire processing operation is sanitized and allows no scope for bacterial or cross contamination. Caution is also exercised in the packing process of these injections. Damages due to breakage are common during packing and hence, extreme care is taken in this last stage of manufacturing.
Quality control of raw material and finished products – Quality check is a continuous process at our works and is done both for ingredients as well as finished injections. Raw materials bought in bulk are procured from genuine sources that conform to international quality standards. These ingredients are once again tested in our factory and checked for their authenticity. Checks are repeated at intermediary levels to ensure their purity continually. These tests are carried out as per latest international standards of drug manufacturing. Stability studies and batch record reviews are done regularly to minimize our risk to ‘zero’. This becomes even more pertinent with injections and medicines as they could be life saving.
Our Premises – Premises includes production, storage, quality control, weighing and ancillary areas. It is essential to maintain our premise in topmost hygienic state, free from any sort of contamination, to adhere to superlative levels of cleanliness. It is our prerogative to maintain our premises in a completely sanitized state so as to achieve highest levels of cleanliness.
In our commitment to offer top quality formulations, we follow the practice of recalling an entire batch of medicines even if a single unit is found defective. As a WHO GMP approved exporter for injection in India, we are always critical about the quality of our product.
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