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Pharmaceutical Guidanace

Mr. 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 remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES

INTRODUCTION To establish inspection consistency and uniformity by discussing practices that has been found acceptable (or unacceptable). The cleaning validation – to validate the process and collect the scientific data that prove the system consistently does as expected and produce a result that consistently meets predetermined specifications. This guide is …

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Non-sterile process validation

Non-sterile process validation Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. The validation should be carried out in accordance with good manufacturing practices (GMP) and data should be held at the manufacturing location and made available …

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URS of De-Dusting Machine

URS of De-Dusting Machine S. No. Table of Contents 1.0 General 2.0 Salient Features 3.0 Operational Requirements 4.0 Utilities 5.0 Maintenance 6.0 Commissioning and Documentation 7.0 Training 8.0 Packaging 9.0 Deviations 10.0 Delivery TECHNICAL  S. No. Parameters Required Specifications 1. 1.1 General Equipment No. 1.2 Description Portable unit for Tablets …

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SOP on house keeping, cleaning and sanitization of general area in Pharmaceutical company

SOP on house keeping, cleaning and sanitization of general area in Pharmaceutical company. Objective :To lay down a procedure for Good House Keeping, cleaning and sanitization of General Area. Scope: This procedure is applicable for cleaning and sanitization of General areas other than manufacturing area of the Pharmaceutical Company. Responsibility: …

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QUALITY SYSTEMS MODEL (Resources)IN PHARMACEUTICAL INDUSTRY (Part – II)

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

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Pharma WhatsApp Groups for Latest Pharma Jobs, Pharma news and Pharma Post

Dear All Please find the Pharma WhatsApp Groups for Latest Pharma Jobs, Pharma news and Pharma Post. Please Click the below link and Join the group easily Pharma Vacancy https://chat.whatsapp.com/CjIJ1h6A0De05we3uX4hK0 Pharmaguidance 01 https://chat.whatsapp.com/EvhBElM2JcuBuOhn0YbPS6 Pharma Post and Jobs 01 https://chat.whatsapp.com/Dy1GkgHZloYJPsfzIC6tnZ Pharma Job & Post 02 https://chat.whatsapp.com/La8yGcVqeknKkfEeymYwMv Pharma jobs & post 03 …

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QUALITY SYSTEMS MODEL IN PHARMACEUTICAL INDUSTRY (Part – I)

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

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CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS Quality should be built into the product, and testing alone cannot be relied on to ensure product quality. Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to …

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What are good documentation practices & how can they best be implemented?

What are good documentation practices & how can they best be implemented? Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from “good distribution practice” also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards …

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Drug Master Files (DMFs) and it submission

Drug Master Files (DMFs) and it submission Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those …

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