The control sample is a portion of a finished product or raw material’s specific lot or the packing material’s few units, preserved in a control area for future analysis and reproducing purposes. Retention of the control sample is a part of the huge documentation process practiced in the pharmaceutical manufacturing industry. A dedicated SOP for […]
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Functions of Quality Control in the Pharmaceutical Industry Introduction: Quality Control is a critical part of a pharmaceutical company. It is a testing laboratory in the pharmaceutical industry. It performs not only the testing of material but also forces all departments to follow quality standards. QC also furnishes documents like COA, calibration of instruments, stability
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Working standards are an integral part of any pharmaceutical laboratory. The working standard allows knowing the assay value of any tested product against the potency of the working standard. There are two types of standards in the laboratory (i) Reference Standard and (ii) Working Standard. Reference Standards are procured from Central Drug Laboratories like CDL
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The pharmaceutical industry is a highly regulated industry by Drug Departments. Every action in the pharmaceutical manufacturing company needs to be documented and verified. Action without documentation is understood as manipulation or out of specification because without SOP no action is permissible in this industry. Therefore, to meet the requirements, proper SOP for maintaining a
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SOP for sampling of Raw Materials In pharmaceutical companies, every job is expected to be done according to a pre-approved SOP. Similarly, SOP for sampling of Raw Materials is assigned for the sampling of incoming raw materials in the company. SOP should contain all directions according to GMP guidelines. The SOP would have to extensively
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The Pharma marketing business is not as easy as it looks, because of drug License liability and other technical issues. Drug license and GST registration are two main legal liabilities, that should have before opening the shutter of your shop. Let’s make the whole process easy and simplify how to start a pharma wholesale business?
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For pharmaceutical manufacturers in India, complying with Schedule M – the cornerstone of Good Manufacturing Practices (GMP) – has long been the game. But the winds of change have blown, ushering in a revised Schedule M, promising a more robust and globally aligned quality management system. Buckle up, because this blog post dives deep into
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Introduction Quality assurance in pharmaceutical industry is an important pillar of any company. Quality assurance (QA) is the central point of all activities performed in a pharmaceutical company, all work goes through the QA department’s approval like research, Raw Material Store, quality control, manufacturing, and sales. QA ensures that pharmaceutical products are manufactured to a
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Pharmaceutical companies are a highly regulated industry in India, it’s not easy to start a manufacturing company like other non-regulated industries. The construction of the building requires a high level of guidance following the Schedule-M norms. The layout of the plant should be as prescribed in the Schedule-M of Drug and Cosmetic Act 1945. There
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The Medicines and Healthcare Products Regulatory Agency (MHRA) is a government agency in the United Kingdom. MHRA’s prime role is to regulate medicines, medical devices, and blood components for transfusion in the UK. MHRA guidelines are very important recommendations for any drug-related activity in the United Kingdom. It is a branch of the Department of
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