How to start Factory in India?

If you are going to start any Pharmaceutical, Ayurvedic, Cosmetic and Food & dietary supplements manufacturing unit and that requires more than ten workers then you have to register your manufacturing unit under Factory Act, 1948 also along with required licenses and documents required for starting pharmaceutical manufacturing unit, Ayurvedic Manufacturing Unit, Cosmetic Manufacturing Unit […]

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WHO Good manufacturing practices for pharmaceutical products

GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing […]

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What is BIHRT? Is it legal to compound and manufacture BIHRT in India

What is BIHRT? Bioidentical Hormone Replacement Therapy. BIHRT is the use of supplemental doses of hormones that have a chemical structure identical to the hormones that the human body naturally produces. Query:   I have a query regarding the regulatory requirements of compounding pharmacies in India. Do Bioidentical hormones come under the category of Ayurvedic […]

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What is Recall in Pharmaceutical Industry? Procedure involved in Product Recall

Product Recall means any action/procedure taken by the manufacturer, importer, marketer, supplier or registrant or enlistment holder of a product to remove it from the market or to retrieve from any person to whom it has been supplied because of the reason that the product;- may be hazardous to health; or/and may fail to conform […]

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What is Quality Control? Basic Requirements for Quality Control

Quality Control means that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has […]

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What is Quality Assurance? Basic Principles of Quality Assurance

Quality assurance means the sum total of the organized arrangements made with the objective of ensuring that medicines and health products are of the quality required for their intended use. The system of quality assurance for the manufacture of medicines and health products should ensure that Medicine and health products are designed and developed in a way […]

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What is GMP and cGMP? Basic Principles of GMP and cGMP

GMP is a short form of Good Manufacturing Practice and cGMP is short form of Current Good Manufacturing Practice. Good Manufacturing Practice is a way of manufacturing followed by manufacturing units to ensure quality and efficacy of a products. Good manufacturing practice is based at standards and guidelines recommended by licensing authorities. It involves production […]

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Who is Production Supervisor? Definition, Job Responsibilities and Qualification

Production Supervisor: Production Supervisor is a person who look after all daily activities of work and follow the instruction of manufacturing chemist. We can say, Production supervisor as semi-technical person to conduct, initiate and perform all manufacturing processes. Number of supervisors present into a unit depend at work load and production capacity of any manufacturing […]

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Machinery and Equipment for Pharmaceutical, Ayurvedic and Nutraceutical Manufacturing Plant

Essential Machinery and Equipment:All the machines are in SS-304 and contact part in SS-316 Liquid and Syrup Section: High speed mixer for 500 liter/1000 liter tank S. S. tank- 200 Liter/500 liter/1000 liter capacity with wheel and cover lid Diagram   Related Article: Manufacturing Solid Dosage Form i.e Tablet/CapsuleManufacturing of Liquid Dosage FormManufacturing of Parenteral Dosage Form […]

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Who is Analytical Chemist? Definition, Job Responsibilities, Qualification etc.

Analytical Chemist: A Pharmaceutical manufacturing unit requires two authorized person for smooth running. One is manufacturing chemist and Second is Analytical Chemist. Analytical Chemist is a person who are responsible for quality, efficacy and sustainability of the product. Read Related: Who is Manufacturing Chemist? Definition, Qualification and Responsibilities How can we define Analytical Chemist?   An […]

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