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Basic Overview of Contamination Control in GMP Facility

Dispensing areas have been designed to minimize the risk of contamination and mix-up. It’s important that only raw materials are dispensed by authorized operators following … See more

Actived: 9 days ago

URL: https://www.gmpsop.com/basic-overview-of-contamination-control-in-gmp-facility/

Supplementary guidelines on good manufacturing practices …

Weba quality appropriate to its purpose. If the herbal medicine is not described in a recognized pharmacopoeia, a herbarium sample of the fl owering or fruiting top of the whole …

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Annex 4 Supplementary guidelines on good manufacturing …

WebAn authorized written procedure giving instructions for performing opera-tions not necessarily specifi c to a given product or material but of a more general nature (e.g. …

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Quality Assessment for Reworking Active Pharmaceutical …

WebThis practice should apply to all GMP Sites where Pharmaceutical and Animal Health API and marketed drug products are produced. Standard Operating …

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Record Keeping and Record Management Practice in GMP

WebAuditors review records to ensure they are accurate and complete and follow GMP. They place importance on this review when forming opinions on company GMP …

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Annex 3 Guidelines on Good Manufacturing Practices for

Web29 sanitized. Adequate precautions should be taken to avoid contamina-tion of the drainage system with radioactive efﬂuents. 4.4 Lighting, heating, ventilation and, if necessary, air …

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Good Working Practice – Facilities and Equipments

Web7. Areas and Facilities Cleaning and Maintenance. -This section of practice document defines the cleaning and maintenance of GMP facilities (e.g., rooms/areas, modules) …

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Health Products and Food Branch Inspectorate

WebHealth Canada / Health Products and Food Branch Inspectorate Good Manufacturing Practices (GMP) Guidelines – 2009 Edition, Version 2 (GUI-0001) / March 4, 2011 Page …

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EHS-130 Environmental Health and Safety Risk Assessment …

WebIn a GMP environment a risk-based approach has to be used to evaluate the hazards and controls used to mitigate them. Hence it is essential for Risk assessments to be …

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EHS-100 Personal Protective Equipment (PPE) Policy for a GMP

WebFind it here! Update Account Profile. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written …

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Guidance 060 – Product Quality Complaint Handling

WebIn addition, the appropriate regulatory agencies and/or competent authorities should be informed, when necessary, if the site is considering action following possibly faulty …

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Standard Operating Procedure Incident Management …

WebA serious incident is an unplanned event, which could have led to seriously harm to people, premises, the environment or the business. In case of a serious environmental incident …

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Good Practice Quality Systems Management Samples

WebDeviations to approved Production, Testing, or Distribution Procedures for Active Pharmaceutical Ingredients (API), Drug Products, Medical Devices, Consumer Health …

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EHS-065 Hot Work Permit Procedure

Web5.1. Initiation of Hot Work Permit 5.1.1 Prior to commencement of any hot work, the Engineering or Facilities representative must be contacted to obtain a blank Hot Work …

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Annex 7 Application of Hazard Analysis and Critical Control …

Web103 Some stages are linked to speciﬁc principles while others serve as an introduction to the concept. The seven principles are: 1. Conduct a hazard analysis.

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Environmental Health and Safety Risk Management

WebThe purpose of this SOP is to: Describe the risk management process of identifying EHS hazards, assessing risk, designing appropriate controls and reviewing the controls. …

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Manual 058 Out of Specification Results Investigation

Web2 Scope and Applicability. This Guideline applies whenever a laboratory test result is out of specification. It may apply to any laboratory, its joint ventures and licensees who operate …

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Guidance 080 Reduced Testing Program

WebGuidance 080 Reduced Testing Program Copyright©www.gmpsop.com. All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the

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Standard Operating Procedure

WebTitle: Environmental Health and Safety Training. Incident / Accident Reporting. Spill Response procedures. First Aid procedures. Use of personal protective equipment. All …

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