Tag: Netherlands

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist Building and Facilities. Check whether Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance. Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and…

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COMPRESSED MEDICAL GASES AS PER USFDA GUIDELINE INTRODUCTION This guideline describes practices and procedures for compressed medical gas (CMG) fillers (including companies engaged in home respiratory services) that constitute acceptable means of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug products (21 CFR Parts 210 and 211). All sections…

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Data Integrity In Pharmaceuticals Data integrity: Data integrity is a fundamental component of information security. In its broadest use, “data integrity” refers to the accuracy, reliability and consistency of data stored over its entire life-cycle in a database, data warehouse, data mart or other construct. The term – Data Integrity – can be used to…

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PROCEDURE FOR VIABLE AIR MONITORING OBJECTIVE:To lay down a procedure for environmental monitoring of air. SCOPE:This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY :Quality Control Executive / Officer. ACCOUNTABILITY:Head Quality Assurance. PROCEDURE:The microbial environmental conditions of unit II shall be monitored by Settle plate method or air sampling at…

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PHARMACOVIGILANCE PLAN AS PER ICH Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug .  Pharmacovigilance Plan that might be submitted at the time of licence application. Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that prefer this approach Pharmacovigilance Plan into the Common…

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INPROCESS CONTROL DURING TABLET MANUFACTURING OBJECTIVE:        To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE:                 This SOP shall be applicable for in process controls during tablets manufacturing. RESPONSIBILITY:             In process Quality Assurance Executive/Officer. ACCOUNTABILITY:          Head Quality Assurance. PROCEDURE: Carry out line clearance at each stage of operation prior to…

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RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven bags with polybag inside Packed…

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International Organization for Standardization ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies.Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. The ISO is a multinational agency . It was established in 1947 as…

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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING Dosage Form: Tablet Date / Time: Product: Batch No.  : Previous product: Batch No.  : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time COATING [Released / Not Released / Hold / Rejected / Not…

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