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Minimum Requirements of EU for Premises and Equipment in Human Pharmaceutical products Manufacturing site  as per EU Guideline before going for EU Regulatory Audit.   PRINCIPLE Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk

Definitions of Pharmaceutical terms as per WHO. The definitions given below apply to the terms used in this guide. They may have different meanings in other contexts. Active Pharmaceutical Ingredient (API) Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes

Process Validation Successful  Process Validation gives assurance about produced Drug Quality . which is Drug should be fit for its intended use. Quality ,  safety and efficacy should be built into the product. Only in-process test & finished products tests can not give assurance of product quality. because of it every step of product manufacturing

current Good manufacturing practices for pharmaceutical products (cGMP) As per WHO 1.1 Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent

SOP on Handling of Incidents and Deviations PROCEDURE: Definition: Departure from an approved instruction or established standard. Deviation shall be lodged when deviation from the written procedure is observed / taken from following documents (but not limited to): SOP BMR BPR STP SPEC. No deviation is permitted from Pharmacopoeia and other Regulatory specifications. However additional