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Pharmaceutical Manufacturing Premises – Risk classification observations

Pharmaceutical Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations Risk 1 (critical) observations There was no air filtration system to eliminate airborne contaminants likely to be generated during fabrication or packaging. There was generalized malfunctioning of the ventilation system(s), with evidence of widespread cross-contamination. Segregation of …

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Process Validation: General Principles (USFDA)

Process Validation: General Principles (USFDA) This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle. The lifecycle concept links product and process …

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Indian pharmacopoeia 2007

Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …

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SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE

SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE INTRODUCTION Technology transfer of a pharmaceutical product from research to the production floor with simultaneous increase in production outputs is commonly known as scale-up. In simple terms, the process of increasing batch size is termed as scale-up. Conversely, …

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PLASTICS AS PACKAGING MATERIAL

PLASTICS AS PACKAGING MATERIAL Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality, and the freedom of design to which they can be changed. Plastic containers are extremely resistant to breakage and thus offer safety to …

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Hold Time Studies Protocol of Ornidazole Tablets 500 mg

Hold Time Studies Protocol of Ornidazole Tablets 500 mg Process Step – Blending/ Lubrication About 500 gms material from blended mass is kept under simulating conditions. The material is subjected to analysis for Assay of Ornidazole,Total & single impurity  and LOD at 0 day, after 7th day & after 15th day. These …

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All Post URL of Drugs formulations

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …

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Sterilization (Introduction, Methods, Definition of Terms)

Sterilization (Introduction, Methods, Definition of Terms) Introduction A major risk of all such medical and surgical instruments procedures is the introduction of pathogens that can lead to infection. Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person …

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Technology Transfer in pharmaceutical manufacturing (WHO)

Technology Transfer in pharmaceutical manufacturing (WHO) Introduction Scope Glossary Organization and management Production: transfer (processing, packaging and cleaning) Quality control: analytical method transfer Premises and equipment Documentation Qualification and validation 1.1 Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, …

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Process Validation Critical Parameters

Process Validation Critical Parameters Process Validation(FDA Definition) Establishing Documented Evidence, Which provides a high degree of assurance that a specific process will  consistently produce a product meeting its predetermined specifications and quality attributes.” Steps in Validating a Process: Develop validation protocol Conduct installation qualification Conduct operational qualification Conduct performance qualification …

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